Introduction: Early gestational diabetes mellitus (EGDM) is a relatively new entity, and there is a lack of clarity regarding treatment. This study was carried out to compare the maternal and neonatal outcomes between treated EGDM and late GDM.
Methods: This prospective cohort study was conducted in a tertiary care teaching hospital in South India. Pregnant women more than 18 years of age with a singleton foetus and diagnosed with GDM on a 75 g oral glucose tolerance test (OGTT) using the World Health Organization (WHO) 2013 criteria were included in the study. The study participants were divided into two groups of 306 each, based on their gestational age at the time of GDM diagnosis. EGDM was diagnosed before 24 weeks of gestation, and late gestational diabetes mellitus (LGDM) was diagnosed at or after 24 weeks of gestation. They were followed until delivery, and the pregnancy outcomes, maternal, and perinatal were documented using a predesigned proforma.
Results: Among the 612 participants, a significantly higher proportion of elderly gravida (>35 years) was observed in the EGDM group compared to LGDM (9.5% vs. 4.3%, P = 0.01). The need for insulin (13.1% vs. 6.9%; adjusted relative risk [aRR]: 1.91, 95% confidence interval [CI]: 1.15-3.14; P = 0.011) was significantly higher in women with EGDM relative to LGDM, after adjusting for confounders. There were no other significant differences in outcomes between women with EGDM and LGDM.
Conclusions: Women with treated EGDM are older and have a significantly higher insulin requirement than LGDM.
简介:妊娠早期糖尿病(EGDM)是一个相对较新的疾病,其治疗方法尚不明确。本研究旨在比较经治疗的EGDM和晚期GDM的产妇和新生儿结局。方法:本前瞻性队列研究在印度南部的一家三级护理教学医院进行。采用世界卫生组织(WHO) 2013年标准,经75克口服葡萄糖耐量试验(OGTT)诊断为GDM的18岁以上单胎孕妇被纳入研究。研究参与者根据GDM诊断时的胎龄分为两组,每组306人。妊娠24周前诊断为EGDM,妊娠24周后诊断为LGDM。随访至分娩,并使用预先设计的形式记录妊娠结局、产妇和围产期。结果:在612名参与者中,EGDM组的高龄孕妇(bb0 ~ 35岁)比例明显高于LGDM组(9.5% vs. 4.3%, P = 0.01)。经混杂因素校正后,EGDM患者对胰岛素的需求(13.1% vs. 6.9%;校正相对危险度[aRR]: 1.91, 95%可信区间[CI]: 1.15-3.14; P = 0.011)显著高于LGDM患者。EGDM和LGDM患者的预后没有其他显著差异。结论:接受治疗的EGDM患者年龄较大,胰岛素需求明显高于LGDM患者。
{"title":"Comparison of Pregnancy Outcomes between Treated Early Gestational Diabetes Mellitus (EGDM) and Late Gestational Diabetes Mellitus (LGDM).","authors":"Manjeera Nekkanti, Mahadevan Duraiswamy, Sadishkumar Kamalanathan, Viswanathan Mohan, Yavana S Venkatesh, Haritha Sagili","doi":"10.4103/ijem.ijem_133_25","DOIUrl":"10.4103/ijem.ijem_133_25","url":null,"abstract":"<p><strong>Introduction: </strong>Early gestational diabetes mellitus (EGDM) is a relatively new entity, and there is a lack of clarity regarding treatment. This study was carried out to compare the maternal and neonatal outcomes between treated EGDM and late GDM.</p><p><strong>Methods: </strong>This prospective cohort study was conducted in a tertiary care teaching hospital in South India. Pregnant women more than 18 years of age with a singleton foetus and diagnosed with GDM on a 75 g oral glucose tolerance test (OGTT) using the World Health Organization (WHO) 2013 criteria were included in the study. The study participants were divided into two groups of 306 each, based on their gestational age at the time of GDM diagnosis. EGDM was diagnosed before 24 weeks of gestation, and late gestational diabetes mellitus (LGDM) was diagnosed at or after 24 weeks of gestation. They were followed until delivery, and the pregnancy outcomes, maternal, and perinatal were documented using a predesigned proforma.</p><p><strong>Results: </strong>Among the 612 participants, a significantly higher proportion of elderly gravida (>35 years) was observed in the EGDM group compared to LGDM (9.5% vs. 4.3%, <i>P</i> = 0.01). The need for insulin (13.1% vs. 6.9%; adjusted relative risk [aRR]: 1.91, 95% confidence interval [CI]: 1.15-3.14; <i>P</i> = 0.011) was significantly higher in women with EGDM relative to LGDM, after adjusting for confounders. There were no other significant differences in outcomes between women with EGDM and LGDM.</p><p><strong>Conclusions: </strong>Women with treated EGDM are older and have a significantly higher insulin requirement than LGDM.</p>","PeriodicalId":13353,"journal":{"name":"Indian Journal of Endocrinology and Metabolism","volume":"29 5","pages":"531-536"},"PeriodicalIF":0.0,"publicationDate":"2025-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12604843/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145503583","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-09-01Epub Date: 2025-10-25DOI: 10.4103/ijem.ijem_28_25
Sai N Gogineni, Adlyne R Asirvatham, Vasireddy N Tara, Veeraraghava K Ramadesikan, Asha Ranjan, Shriraam Mahadevan
Introduction: Immunoassays used to measure thyroid function tests (TFTs) are prone to interference due to several factors that could potentially affect clinical decisions. With increased awareness and frequency of testing TFT, even 1% prevalence of assay interferences would possibly increase the occurrence of deranged TFT significantly. In this study, we report six cases of thyroid hormone assay interference in acute scrub typhus infection.
Methods: A prospective observational study was conducted in patients admitted with acute scrub typhus infection. TFT was done for some indication that showed discordance with clinical suspicion. Initial assay was performed by electrochemiluminescence immunoassay (ECLIA) using a Roche Cobas e411 analyzer, which was verified by Chemiluminescent Microparticle Immuno Assay (CMIA) with an ARCHITECT i1000SR analyzer.
Results: Initial TFT done by ECLIA showed elevated FT4 and FT3(FT4>> FT3) with a normal or low-normal TSH in all cases. Samples were re-analyzed in the CMIA platform within 24 hours, which showed normal TFT, raising the suspicion of assay interference. TFT performed by ECLIA 6 weeks after recovery was normal in all patients.
Conclusion: Assay interference with TFT should always be considered when there is a discrepancy between clinical suspicion and biochemical values. It is prudent to confirm abnormal values on another platform to avoid misdiagnosis and unwarranted therapeutic decisions.
{"title":"Variation in Thyroid Function Tests in Acute Scrub Typhus Infection.","authors":"Sai N Gogineni, Adlyne R Asirvatham, Vasireddy N Tara, Veeraraghava K Ramadesikan, Asha Ranjan, Shriraam Mahadevan","doi":"10.4103/ijem.ijem_28_25","DOIUrl":"10.4103/ijem.ijem_28_25","url":null,"abstract":"<p><strong>Introduction: </strong>Immunoassays used to measure thyroid function tests (TFTs) are prone to interference due to several factors that could potentially affect clinical decisions. With increased awareness and frequency of testing TFT, even 1% prevalence of assay interferences would possibly increase the occurrence of deranged TFT significantly. In this study, we report six cases of thyroid hormone assay interference in acute scrub typhus infection.</p><p><strong>Methods: </strong>A prospective observational study was conducted in patients admitted with acute scrub typhus infection. TFT was done for some indication that showed discordance with clinical suspicion. Initial assay was performed by electrochemiluminescence immunoassay (ECLIA) using a Roche Cobas e411 analyzer, which was verified by Chemiluminescent Microparticle Immuno Assay (CMIA) with an ARCHITECT i1000SR analyzer.</p><p><strong>Results: </strong>Initial TFT done by ECLIA showed elevated FT4 and FT3(FT4>> FT3) with a normal or low-normal TSH in all cases. Samples were re-analyzed in the CMIA platform within 24 hours, which showed normal TFT, raising the suspicion of assay interference. TFT performed by ECLIA 6 weeks after recovery was normal in all patients.</p><p><strong>Conclusion: </strong>Assay interference with TFT should always be considered when there is a discrepancy between clinical suspicion and biochemical values. It is prudent to confirm abnormal values on another platform to avoid misdiagnosis and unwarranted therapeutic decisions.</p>","PeriodicalId":13353,"journal":{"name":"Indian Journal of Endocrinology and Metabolism","volume":"29 5","pages":"578-581"},"PeriodicalIF":0.0,"publicationDate":"2025-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12604834/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145503543","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-09-01Epub Date: 2025-10-25DOI: 10.4103/ijem.ijem_183_25
Shahnaz A Mir, Mohammad S Baba, Javaid A Bhat, Mohammad H Bhat, Abid H Bhat, Md E Alam, Basharat Q Q Dar, Nadia Shafi, Showkat A Kadla, Bashir A Laway
Introduction: Patients with Sheehan's syndrome (SS) commonly exhibit cardiovascular risk factors, including abdominal obesity, dyslipidaemia, hepatic steatosis and chronic inflammation. In addition, quality of life (QOL) is poor despite adequate replacement with glucocorticoids and thyroxine. This study evaluated the effects of growth hormone (GH) replacement on body mass index (BMI), lipid profile, body/hepatic fat and QOL in SS patients.
Methods: This prospective study enrolled 14 SS patients with GH deficiency on stable hormonal therapy (excluding GH). Waist-hip ratio (WHR), BMI, lipids, liver steatosis and fibrosis, body fat (by dual energy X-ray absorptiometry) and QoL (using QOL in Adult GH Deficiency Assessment (QoL-AGHDA)) were assessed at baseline and after 24 weeks of GH replacement.
Results: The mean age of the patients was 55.7 ± 6.9 years, with a mean disease duration of 19.4 ± 1.6 years (range, 8-27 years). After GH replacement, total cholesterol decreased from 213.35 ± 43.66 to 189.29 ± 23.49 mg/dl, LDL-cholesterol from 120.79 ± 38.73 to 89.36 ± 20.47 mg/dl and triglycerides from 288.79 ± 91 to 231.50 ± 47.15 mg/dl, while HDL-cholesterol increased from 41.29 ± 11.44 to 45.64 ± 4.39 mg/dl. Total body fat reduced from 39.97 ± 5.0% to 37.99 ± 4.5% (P = 0.015); WHR and BMI remained unchanged. Liver fat (controlled attenuation parameter) decreased from 248.64 ± 42.14 to 230.29 ± 36.86 dB/m (P = 0.025) and liver stiffness from 5.13 ± 0.90 to 4.53 ± 1.25 kPa (P = 0.025). QoL-AGHDA scores improved from 11.79 ± 3.14 to 4 ± 3.06.
Conclusion: GH replacement in SS patients improves lipid parameters, reduces body and hepatic fat and enhances QOL.
{"title":"Effect of Growth Hormone Therapy on Cardiometabolic Risk Factors, Hepatic Fat Content and Quality of Life in Patients with Sheehan's Syndrome.","authors":"Shahnaz A Mir, Mohammad S Baba, Javaid A Bhat, Mohammad H Bhat, Abid H Bhat, Md E Alam, Basharat Q Q Dar, Nadia Shafi, Showkat A Kadla, Bashir A Laway","doi":"10.4103/ijem.ijem_183_25","DOIUrl":"10.4103/ijem.ijem_183_25","url":null,"abstract":"<p><strong>Introduction: </strong>Patients with Sheehan's syndrome (SS) commonly exhibit cardiovascular risk factors, including abdominal obesity, dyslipidaemia, hepatic steatosis and chronic inflammation. In addition, quality of life (QOL) is poor despite adequate replacement with glucocorticoids and thyroxine. This study evaluated the effects of growth hormone (GH) replacement on body mass index (BMI), lipid profile, body/hepatic fat and QOL in SS patients.</p><p><strong>Methods: </strong>This prospective study enrolled 14 SS patients with GH deficiency on stable hormonal therapy (excluding GH). Waist-hip ratio (WHR), BMI, lipids, liver steatosis and fibrosis, body fat (by dual energy X-ray absorptiometry) and QoL (using QOL in Adult GH Deficiency Assessment (QoL-AGHDA)) were assessed at baseline and after 24 weeks of GH replacement.</p><p><strong>Results: </strong>The mean age of the patients was 55.7 ± 6.9 years, with a mean disease duration of 19.4 ± 1.6 years (range, 8-27 years). After GH replacement, total cholesterol decreased from 213.35 ± 43.66 to 189.29 ± 23.49 mg/dl, LDL-cholesterol from 120.79 ± 38.73 to 89.36 ± 20.47 mg/dl and triglycerides from 288.79 ± 91 to 231.50 ± 47.15 mg/dl, while HDL-cholesterol increased from 41.29 ± 11.44 to 45.64 ± 4.39 mg/dl. Total body fat reduced from 39.97 ± 5.0% to 37.99 ± 4.5% (<i>P</i> = 0.015); WHR and BMI remained unchanged. Liver fat (controlled attenuation parameter) decreased from 248.64 ± 42.14 to 230.29 ± 36.86 dB/m (<i>P</i> = 0.025) and liver stiffness from 5.13 ± 0.90 to 4.53 ± 1.25 kPa (<i>P</i> = 0.025). QoL-AGHDA scores improved from 11.79 ± 3.14 to 4 ± 3.06.</p><p><strong>Conclusion: </strong>GH replacement in SS patients improves lipid parameters, reduces body and hepatic fat and enhances QOL.</p>","PeriodicalId":13353,"journal":{"name":"Indian Journal of Endocrinology and Metabolism","volume":"29 5","pages":"562-566"},"PeriodicalIF":0.0,"publicationDate":"2025-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12604848/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145503727","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Introduction: Individuals living with obesity are prone to vitamin D deficiency. On supplementing vitamin D, lower serum 25(OH)D levels may be achieved in them. The present study aimed to compare the change in serum 25(OH)D after supplementation with vitamin D in children living with obesity versus children with normal body mass index (nBMI) and to study its correlation with BMI and fat mass (FM).
Method: Sixty vitamin D-deficient children (Groups 1-30 with BMI ≥23rd adult equivalent of Indian Academy of Pediatrics BMI charts and Groups 2-30 nBMI children) were administered oral vitamin D3 (60,000 IU weekly for five doses) in an open-labelled nonrandomised controlled trial. Serum 25(OH)D was measured before intervention and at days 7, 30 and 90 post-intervention, along with serum and urine calcium.
Results: The change/rise in 25(OH)D was significantly less in Group 1at days 7, 30 and 90. At day 30, the rise was 25% lower than in Group 2 and had a negative correlation with BMI (r = -0.412, P = 0.001) and FM (r = -0.452, P = 0.002). The mean circulating levels at days 30 and 90 were 20% lower in Group 1. The area under curve of the 25(OH)D profile in the two groups demonstrated a significant difference between the groups (3776.9 ± 780.0 in Group 1 vs 4857.9 ± 1267.8 in Group 2, P = 0.0002). Transient hypervitaminosis (without hypercalcaemia or hypercalciuria) was seen in 2/28 of Group 1 and 8/30 of Group 2 (only at day 7).
Conclusion: The higher BMI children had a 25% lower rise in serum 25(OH)D levels.
简介:肥胖的人容易缺乏维生素D。补充维生素D,可以降低血清25(OH)D水平。本研究旨在比较肥胖儿童与正常体重指数(nBMI)儿童补充维生素D后血清25(OH)D的变化,并研究其与BMI和脂肪质量(FM)的相关性。方法:在一项开放标记的非随机对照试验中,60名维生素d缺乏儿童(BMI≥23的印度儿科学会成人BMI图表1-30组和2-30组非BMI儿童)被给予口服维生素D3(每周60000 IU,共5次)。在干预前、干预后第7天、30天和90天测定血清25(OH)D,以及血清和尿钙。结果:第1组在第7、30、90天25(OH)D的变化/升高明显小于第1组。第30天,升高幅度比第2组低25%,且与BMI (r = -0.412, P = 0.001)和FM (r = -0.452, P = 0.002)呈负相关。第1组在第30天和第90天的平均循环水平降低20%。两组25(OH)D谱曲线下面积差异有统计学意义(1组为3776.9±780.0,2组为4857.9±1267.8,P = 0.0002)。1组2/28和2组8/30(仅在第7天)出现短暂性维生素过多症(无高钙血症或高钙尿症)。结论:BMI越高的儿童血清25(OH)D水平的升高幅度要低25%。
{"title":"Response to Weekly Oral Vitamin D Supplementation in Children Living with Obesity versus those with Normal BMI.","authors":"Kanhaiya Lal, Shikha Sharma, Medha Mittal, Rajesh Khadgawat, Kirtisudha Mishra, Sreenivas Vishnubhatla","doi":"10.4103/ijem.ijem_162_25","DOIUrl":"10.4103/ijem.ijem_162_25","url":null,"abstract":"<p><strong>Introduction: </strong>Individuals living with obesity are prone to vitamin D deficiency. On supplementing vitamin D, lower serum 25(OH)D levels may be achieved in them. The present study aimed to compare the change in serum 25(OH)D after supplementation with vitamin D in children living with obesity versus children with normal body mass index (nBMI) and to study its correlation with BMI and fat mass (FM).</p><p><strong>Method: </strong>Sixty vitamin D-deficient children (Groups 1-30 with BMI ≥23<sup>rd</sup> adult equivalent of Indian Academy of Pediatrics BMI charts and Groups 2-30 nBMI children) were administered oral vitamin D3 (60,000 IU weekly for five doses) in an open-labelled nonrandomised controlled trial. Serum 25(OH)D was measured before intervention and at days 7, 30 and 90 post-intervention, along with serum and urine calcium.</p><p><strong>Results: </strong>The change/rise in 25(OH)D was significantly less in Group 1at days 7, 30 and 90. At day 30, the rise was 25% lower than in Group 2 and had a negative correlation with BMI (<i>r</i> = -0.412, <i>P</i> = 0.001) and FM (<i>r</i> = -0.452, <i>P</i> = 0.002). The mean circulating levels at days 30 and 90 were 20% lower in Group 1. The area under curve of the 25(OH)D profile in the two groups demonstrated a significant difference between the groups (3776.9 ± 780.0 in Group 1 vs 4857.9 ± 1267.8 in Group 2, <i>P</i> = 0.0002). Transient hypervitaminosis (without hypercalcaemia or hypercalciuria) was seen in 2/28 of Group 1 and 8/30 of Group 2 (only at day 7).</p><p><strong>Conclusion: </strong>The higher BMI children had a 25% lower rise in serum 25(OH)D levels.</p>","PeriodicalId":13353,"journal":{"name":"Indian Journal of Endocrinology and Metabolism","volume":"29 5","pages":"555-561"},"PeriodicalIF":0.0,"publicationDate":"2025-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12604838/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145503739","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Introduction: The risk of recurrent/persistent disease (RD/PD) in differentiated thyroid cancer (DTC) is predicted using American Thyroid Association (ATA) Risk Stratification System (RSS) guidelines - 2009 followed by revision in 2015, which necessitated a more detailed histopathology report which was not available in resource poor settings. A comparative study of the two systems was done to assess the change in risk status and the impact on outcome in a cohort of DTC patients.
Methods: Clinico-pathologic parameters of 221 adults with DTC who had total thyroidectomy with subsequent radioactive iodine ablation were analysed to reassign risk category according to the ATA RSS 2009 and 2015, and the clinical end points were compared between both systems.
Results: Among the 127 subjects in the intermediate risk category of ATA RSS-2009, when re-categorised under ATA RSS-2015, only 12 subjects (9.4%) had a change of risk status. Response to therapy at 1 year and final outcome were comparable among the similar risk categories, irrespective of the ATA system used. ATA RSS-2009 and ATA RSS-2015 were comparable in predicting the outcome at final follow-up.
Conclusion: When risk status was reassigned with ATA RSS-2015, the study showed a shift in the intermediate risk category of ATA RSS-2009, but this was not statistically significant. Moreover, in predicting the outcome, ATA RSS 2015 was similar to ATA RSS-2009. This implies that the ATA RSS-2009 can be used for the initial risk stratification of patients in a resource-poor setting where the availability of complete histopathological data may be lacking.
{"title":"Comparative Study of Two Successive American Thyroid Association Risk Stratification Systems in Patients with Differentiated Thyroid Cancer in India.","authors":"Malavika Satheesh, Malini Eapen, Usha V Menon, Vasantha Nair, Niveditha Kartha","doi":"10.4103/ijem.ijem_64_25","DOIUrl":"10.4103/ijem.ijem_64_25","url":null,"abstract":"<p><strong>Introduction: </strong>The risk of recurrent/persistent disease (RD/PD) in differentiated thyroid cancer (DTC) is predicted using American Thyroid Association (ATA) Risk Stratification System (RSS) guidelines - 2009 followed by revision in 2015, which necessitated a more detailed histopathology report which was not available in resource poor settings. A comparative study of the two systems was done to assess the change in risk status and the impact on outcome in a cohort of DTC patients.</p><p><strong>Methods: </strong>Clinico-pathologic parameters of 221 adults with DTC who had total thyroidectomy with subsequent radioactive iodine ablation were analysed to reassign risk category according to the ATA RSS 2009 and 2015, and the clinical end points were compared between both systems.</p><p><strong>Results: </strong>Among the 127 subjects in the intermediate risk category of ATA RSS-2009, when re-categorised under ATA RSS-2015, only 12 subjects (9.4%) had a change of risk status. Response to therapy at 1 year and final outcome were comparable among the similar risk categories, irrespective of the ATA system used. ATA RSS-2009 and ATA RSS-2015 were comparable in predicting the outcome at final follow-up.</p><p><strong>Conclusion: </strong>When risk status was reassigned with ATA RSS-2015, the study showed a shift in the intermediate risk category of ATA RSS-2009, but this was not statistically significant. Moreover, in predicting the outcome, ATA RSS 2015 was similar to ATA RSS-2009. This implies that the ATA RSS-2009 can be used for the initial risk stratification of patients in a resource-poor setting where the availability of complete histopathological data may be lacking.</p>","PeriodicalId":13353,"journal":{"name":"Indian Journal of Endocrinology and Metabolism","volume":"29 5","pages":"573-577"},"PeriodicalIF":0.0,"publicationDate":"2025-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12604840/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145503656","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-09-01Epub Date: 2025-10-25DOI: 10.4103/ijem.ijem_179_25
Debmalya Sanyal, Banshi Saboo, Sanjeev R Phatak, Prasanna K M Kumar, Debasis Basu, Nikhil Verma, Arjun Nair, Kingshuk Bhattacharjee, Pankaj Aneja, Brij M M Makkar, Vijay Negalur, Ambrish Mithal, Ambika G Unnikrishnan
Introduction: The PIONEER REAL India study assessed the effectiveness of oral semaglutide in adults with type 2 diabetes (T2D).
Methods: This was a 34-44-week, multicenter, non-interventional study in participants who had not previously received injectable glucose-lowering medications and had initiated treatment with oral semaglutide. Change in HbA1c from baseline to end-of-study (EoS) was the primary endpoint. Change in body weight, proportion of participants achieving HbA1c <7% and HbA1c reduction ≥1%-points plus body weight reduction ≥3% or ≥5%, also changes in HbA1c by baseline HbA1c (≤9% and >9%) from baseline to EoS were assessed. Here, we present the results from on-treatment analyses.
Results: Of 388 enrolled, 70.1% of participants completed the study. At baseline, the mean age and T2D duration of the study population were 50.1 and 6.3 years; mean HbA1c and body weight were 9.0% and 89.0 kg, respectively. Estimated mean changes (95% confidence interval, CI) in HbA1c and body weight were - 1.78%-points (-1.88, -1.68; P < 0.0001) and - 7.23 kg (-7.84, -6.63; P < 0.0001), respectively. At EoS, 34.2% achieved HbA1c <7%. Estimated mean HbA1c changes (95% CI) for participants with baseline HbA1c ≤9% and >9% were - 0.93%-points (-1.07, -0.79; P < 0.0001) and - 2.48%-points (-2.60, -2.35; P < 0.0001), respectively. No new safety signals were observed.
Conclusions: Individuals with T2D treated with once-daily oral semaglutide experienced significant reductions in HbA1c and body weight, without any new safety events. These findings will add to the decision-making for initiating oral semaglutide in individuals with T2D in India.Trial registration: NCT05502562.
{"title":"Real-World Usage of Once-Daily Oral Semaglutide in Adults with Type 2 Diabetes: Findings from PIONEER REAL India.","authors":"Debmalya Sanyal, Banshi Saboo, Sanjeev R Phatak, Prasanna K M Kumar, Debasis Basu, Nikhil Verma, Arjun Nair, Kingshuk Bhattacharjee, Pankaj Aneja, Brij M M Makkar, Vijay Negalur, Ambrish Mithal, Ambika G Unnikrishnan","doi":"10.4103/ijem.ijem_179_25","DOIUrl":"10.4103/ijem.ijem_179_25","url":null,"abstract":"<p><strong>Introduction: </strong>The PIONEER REAL India study assessed the effectiveness of oral semaglutide in adults with type 2 diabetes (T2D).</p><p><strong>Methods: </strong>This was a 34-44-week, multicenter, non-interventional study in participants who had not previously received injectable glucose-lowering medications and had initiated treatment with oral semaglutide. Change in HbA<sub>1c</sub> from baseline to end-of-study (EoS) was the primary endpoint. Change in body weight, proportion of participants achieving HbA<sub>1c</sub> <7% and HbA<sub>1c</sub> reduction ≥1%-points plus body weight reduction ≥3% or ≥5%, also changes in HbA<sub>1c</sub> by baseline HbA<sub>1c</sub> (≤9% and >9%) from baseline to EoS were assessed. Here, we present the results from on-treatment analyses.</p><p><strong>Results: </strong>Of 388 enrolled, 70.1% of participants completed the study. At baseline, the mean age and T2D duration of the study population were 50.1 and 6.3 years; mean HbA<sub>1c</sub> and body weight were 9.0% and 89.0 kg, respectively. Estimated mean changes (95% confidence interval, CI) in HbA<sub>1c</sub> and body weight were - 1.78%-points (-1.88, -1.68; <i>P</i> < 0.0001) and - 7.23 kg (-7.84, -6.63; <i>P</i> < 0.0001), respectively. At EoS, 34.2% achieved HbA<sub>1c</sub> <7%. Estimated mean HbA<sub>1c</sub> changes (95% CI) for participants with baseline HbA<sub>1c</sub> ≤9% and >9% were - 0.93%-points (-1.07, -0.79; <i>P</i> < 0.0001) and - 2.48%-points (-2.60, -2.35; <i>P</i> < 0.0001), respectively. No new safety signals were observed.</p><p><strong>Conclusions: </strong>Individuals with T2D treated with once-daily oral semaglutide experienced significant reductions in HbA<sub>1c</sub> and body weight, without any new safety events. These findings will add to the decision-making for initiating oral semaglutide in individuals with T2D in India.<b>Trial registration:</b> NCT05502562.</p>","PeriodicalId":13353,"journal":{"name":"Indian Journal of Endocrinology and Metabolism","volume":"29 5","pages":"523-530"},"PeriodicalIF":0.0,"publicationDate":"2025-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12604836/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145503730","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-09-01Epub Date: 2025-10-25DOI: 10.4103/ijem.ijem_85_25
Sunetra Mondal, Deep K Hathi, Saptarshi Bhattacharya, Sanjay Kalra
Testosterone is a predominantly anabolic hormone whereas cortisol is a catabolic hormone. Measurement of testosterone-cortisol ratio (TCR) can serve as a surrogate for the balance in the anabolic: catabolic states in the body and was studied as a marker in different aspects of sports endocrinology. However, data is limited and conflicting. A comprehensive search using the PubMed and Google Scholar data base was conducted to write a narrative review summarising all available evidences of TCR in endocrinology and their clinical. TCR has been found to be important in predicting overtraining syndrome, timing peak performance in competitive sports in athletes, psychologic stress, social aggressive behaviour and has also been tested as a marker of increased cardiovascular risk. However, there are several controversies regarding its application and a definite threshold has not been established. TCR has many potential applications in clinical endocrine practice but needs further research.
{"title":"The Testosterone: Cortisol Ratio - A Tool with Practical Use and Research Potential in Endocrinology.","authors":"Sunetra Mondal, Deep K Hathi, Saptarshi Bhattacharya, Sanjay Kalra","doi":"10.4103/ijem.ijem_85_25","DOIUrl":"10.4103/ijem.ijem_85_25","url":null,"abstract":"<p><p>Testosterone is a predominantly anabolic hormone whereas cortisol is a catabolic hormone. Measurement of testosterone-cortisol ratio (TCR) can serve as a surrogate for the balance in the anabolic: catabolic states in the body and was studied as a marker in different aspects of sports endocrinology. However, data is limited and conflicting. A comprehensive search using the PubMed and Google Scholar data base was conducted to write a narrative review summarising all available evidences of TCR in endocrinology and their clinical. TCR has been found to be important in predicting overtraining syndrome, timing peak performance in competitive sports in athletes, psychologic stress, social aggressive behaviour and has also been tested as a marker of increased cardiovascular risk. However, there are several controversies regarding its application and a definite threshold has not been established. TCR has many potential applications in clinical endocrine practice but needs further research.</p>","PeriodicalId":13353,"journal":{"name":"Indian Journal of Endocrinology and Metabolism","volume":"29 5","pages":"510-516"},"PeriodicalIF":0.0,"publicationDate":"2025-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12604835/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145503522","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-09-01Epub Date: 2025-10-25DOI: 10.4103/ijem.ijem_878_25
Ambrish Mithal
{"title":"Changing Concepts in Osteoporosis Management and their Relevance to India.","authors":"Ambrish Mithal","doi":"10.4103/ijem.ijem_878_25","DOIUrl":"10.4103/ijem.ijem_878_25","url":null,"abstract":"","PeriodicalId":13353,"journal":{"name":"Indian Journal of Endocrinology and Metabolism","volume":"29 5","pages":"481-483"},"PeriodicalIF":0.0,"publicationDate":"2025-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12604833/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145503625","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-09-01Epub Date: 2025-09-16DOI: 10.4103/ijem.ijem_13_25
Pramila Kalra, Gurinder Mohan, Prasanta K Bhattacharya, Iada Tiewsoh, Raveendra K Ramamurthy, Ravi M Kiran, Sreejith N Kumar, Sujoy Ghosh, Mala Dharmalingam, Chitra Selvan, Kaushik Pandit, Richa G Thaman, Monaliza Lyngdoh, Pradip Mukhopadhyay, Manish Chandey, Smitha Jain, Sundararaman Rajagopalan, Vedantha J Srinivas, Veena Sreejith, Reetu Singh, Theertha Sekhar, Mercy R Elizabeth, Sreelakshmi P Ramakrishnan
Introduction: Diabetes mellitus (DM) is a major public health concern in India. A diabetes registry provides a reliable method for collecting real-world data on patients in a variety of situations. Despite the high prevalence of diabetes in India, there is a lack of systematic data on the disease's progression, complications, treatment patterns, and outcomes.
Methods: This registry is planned to create a readymade set of patients who will be ready for future clinical trials and will be able to continuously provide data on real-world practices and standards of care for diabetes mellitus in India. To ensure the correct blend in site selection, the centers have been chosen from different geographical regions across India, with a combination of government and private sectors. All sites will use the same protocol, training, SOPs, and data management to achieve harmonization in the process. Patients with known instances of Type 1 and Type 2 diabetes mellitus who will attend seven hospitals' outpatient departments (OPD) will be screened for eligibility and willingness to participate in future clinical studies after signing an informed consent or assent form (if minor). A common IT platform for entering and preserving registry data has been developed, which will enable us to establish a central database.
Conclusion: A national diabetes registry can provide useful insights into the epidemiology, risk factors, and outcomes of diabetes in India by combining clinical, demographic, and behavioral data. This information is critical for designing evidence-based therapies, optimizing resource allocation, and increasing the quality of care for diabetes patients.
{"title":"Study Protocol for Multicentric Hospital-Based Diabetes Registry-Clinical Trial Network.","authors":"Pramila Kalra, Gurinder Mohan, Prasanta K Bhattacharya, Iada Tiewsoh, Raveendra K Ramamurthy, Ravi M Kiran, Sreejith N Kumar, Sujoy Ghosh, Mala Dharmalingam, Chitra Selvan, Kaushik Pandit, Richa G Thaman, Monaliza Lyngdoh, Pradip Mukhopadhyay, Manish Chandey, Smitha Jain, Sundararaman Rajagopalan, Vedantha J Srinivas, Veena Sreejith, Reetu Singh, Theertha Sekhar, Mercy R Elizabeth, Sreelakshmi P Ramakrishnan","doi":"10.4103/ijem.ijem_13_25","DOIUrl":"10.4103/ijem.ijem_13_25","url":null,"abstract":"<p><strong>Introduction: </strong>Diabetes mellitus (DM) is a major public health concern in India. A diabetes registry provides a reliable method for collecting real-world data on patients in a variety of situations. Despite the high prevalence of diabetes in India, there is a lack of systematic data on the disease's progression, complications, treatment patterns, and outcomes.</p><p><strong>Methods: </strong>This registry is planned to create a readymade set of patients who will be ready for future clinical trials and will be able to continuously provide data on real-world practices and standards of care for diabetes mellitus in India. To ensure the correct blend in site selection, the centers have been chosen from different geographical regions across India, with a combination of government and private sectors. All sites will use the same protocol, training, SOPs, and data management to achieve harmonization in the process. Patients with known instances of Type 1 and Type 2 diabetes mellitus who will attend seven hospitals' outpatient departments (OPD) will be screened for eligibility and willingness to participate in future clinical studies after signing an informed consent or assent form (if minor). A common IT platform for entering and preserving registry data has been developed, which will enable us to establish a central database.</p><p><strong>Conclusion: </strong>A national diabetes registry can provide useful insights into the epidemiology, risk factors, and outcomes of diabetes in India by combining clinical, demographic, and behavioral data. This information is critical for designing evidence-based therapies, optimizing resource allocation, and increasing the quality of care for diabetes patients.</p>","PeriodicalId":13353,"journal":{"name":"Indian Journal of Endocrinology and Metabolism","volume":"29 5","pages":"542-547"},"PeriodicalIF":0.0,"publicationDate":"2025-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12604845/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145503699","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-09-01Epub Date: 2025-10-25DOI: 10.4103/ijem.ijem_24_25
Harisankar K Das, Thiruchengodu R Kanmani, Prasad N Nagamangala, Pramila Kalra, Sridhar Rajendaran
The current systematic review aims to check the impact of gender-affirming interventions (GAIs) on the mental health and body satisfaction of transgender individuals. The literature search was carried out in PubMed, ProQuest, and Scopus, and screening was done based on PRISMA guidelines. Data were extracted using a custom-developed template, and quality assessment was carried out using ROBINS-I and ROB-2. Sixteen studies were finalised for the review. Data were synthesised narratively based on the impact of these GAIs on anxiety, depression, self-harm, and body image satisfaction. Individuals who received the GAIs showed significant improvement in their mental health and body image acceptance. A system of integrative medical, surgical, and psychological interventions for transgender healthcare by incorporating the clinicians, researchers, and policymakers relied on comprehensive evidence on the diverse experiences of transgender individuals. The long-term effects of GAIs remain unclear, underscoring the need for further longitudinal research.
{"title":"Impact of Gender-Affirming Interventions on Mental Health and Body Image Satisfaction of Transgender Individuals: A Systematic Review.","authors":"Harisankar K Das, Thiruchengodu R Kanmani, Prasad N Nagamangala, Pramila Kalra, Sridhar Rajendaran","doi":"10.4103/ijem.ijem_24_25","DOIUrl":"10.4103/ijem.ijem_24_25","url":null,"abstract":"<p><p>The current systematic review aims to check the impact of gender-affirming interventions (GAIs) on the mental health and body satisfaction of transgender individuals. The literature search was carried out in PubMed, ProQuest, and Scopus, and screening was done based on PRISMA guidelines. Data were extracted using a custom-developed template, and quality assessment was carried out using ROBINS-I and ROB-2. Sixteen studies were finalised for the review. Data were synthesised narratively based on the impact of these GAIs on anxiety, depression, self-harm, and body image satisfaction. Individuals who received the GAIs showed significant improvement in their mental health and body image acceptance. A system of integrative medical, surgical, and psychological interventions for transgender healthcare by incorporating the clinicians, researchers, and policymakers relied on comprehensive evidence on the diverse experiences of transgender individuals. The long-term effects of GAIs remain unclear, underscoring the need for further longitudinal research.</p>","PeriodicalId":13353,"journal":{"name":"Indian Journal of Endocrinology and Metabolism","volume":"29 5","pages":"484-494"},"PeriodicalIF":0.0,"publicationDate":"2025-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12604846/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145503703","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}