Clinical Diabetes and Endocrinology最新文献

Background: Thyroid dysfunction in pregnancy can adversely impact maternal and fetal outcomes. However, the association between thyroid status and specific adverse outcomes needs clarity, especially in understudied regions.

Objective: This prospective cohort study aimed to illuminate the multifaceted associations between maternal thyroid dysfunction and feto-maternal outcomes in Gujarat, India.

Methods: This hospital-based cohort study recruited and monitored 500 euthyroid, 250 hypothyroid, and 150 hyperthyroid pregnant women until delivery. Maternal thyroid status was determined by serum thyroid stimulating hormone (TSH) and free thyroxine (fT4) levels. Adverse fetal outcomes included preterm birth, neonatal intensive care unit (NICU) admission, respiratory issues, and low APGAR scores. Maternal outcomes included preeclampsia, haemorrhage, hypertension, postpartum thyroiditis, and thromboembolism. Relative risks quantified associations between thyroid dysfunction and outcomes.

Results: Compared to euthyroid women, hypothyroid women had a higher RR for preterm birth (RR 1.8, 95% CI 1.1-3.0), low APGAR score (RR 2.5, 95% CI 1.5-4.1), preeclampsia (RR 3.0, 95% CI 1.9-4.8), postpartum haemorrhage (RR 1.6, 95% CI 1.2-2.1), and venous thromboembolism (RR 3.1, 95% CI 1.7-5.7). Hyperthyroid women had over twice the risk of low APGAR score (RR 1.8, 95% CI 0.9-3.5), neonatal hypoglycemia (RR 1.5, 95% CI 0.5-4.3), respiratory distress (RR 1.4, 95% CI 0.7-2.8), and postpartum thyroiditis (RR 2.3, 95% CI 1.1-4.8).

Conclusion: Maternal thyroid dysfunction escalates risks for adverse fetal and maternal outcomes. Thyroid monitoring and management during pregnancy are critical to mitigate complications.

Aims: The ICMR INDIAB-17 study revealed a diabetes prevalence of 11.4% in India, emphasizing the need for effective treatment for glycemic control. A Phase IV study was conducted to evaluate the safety and efficacy of a Fixed Dose Combination (FDC) of Remogliflozin, Metformin and Vildagliptin (RMV) in Type 2 Diabetes Mellitus (T2DM) patients uncontrolled on Metformin plus SGLT2 inhibitor or Metformin plus DPP4 inhibitor dual therapy.

Methods: A total of 215 patients (mean age: 46.4 years; 64% male, 36% female) were enrolled across multiple centers in India. The study population included patients with a baseline HbA1c ≥ 8% at the time of screening. The primary objective was to assess safety based on treatment-emergent adverse events (TEAEs), while the secondary. aim was to evaluate effectiveness in terms of glycemic (HbA1c, fasting plasma glucose, postprandial glucose) and extra-glycemic measures (renal and lipid parameters). Statistical analysis was conducted using paired t-tests and the Wilcoxon signed-rank test for within-group comparisons, and the Bonferroni correction was applied to adjust for multiple comparisons. Effectiveness was evaluated at baseline, week 12, and week 24.

Results: The study demonstrated statistically significant reductions in mean HbA1c levels from baseline to both week 12 and week 24 (p < 0.00001). At 24, weeks, 45.1% of patients achieved target HbA1c levels of ≤ 7%. Significant reduction was also observed in fasting plasma glucose (FPG) and postprandial glucose (PPG) levels. Renal parameters remained stable or improved, and lipid profile parameters, including LDL-C and triglycerides, showed favorable changes. Adverse events of special interest, including hypoglycemia and urinary tract infections, were reported in 4.7% of patients, with no serious adverse event recorded.

Conclusions: The twice daily triple FDC of RMV was well tolerated, safe and effective in patients with Type 2 Diabetes Mellitus uncontrolled on dual drug therapy of Metformin plus SGLT2i or Metformin plus DPP4i. The treatment led to significant improvements in glycemic control and other metabolic parameters over 24 weeks, without compromising renal function or causing serious adverse events.

Trial registration: CTRI, CTRI/2022/05/042581. Registered 17 May 2022, https//ctri.nic.in/Clinicaltrials/rmaindet.php? trialid=68,757&EncHid=36127.16500&modid=1&compid=19.

Background: This meta-analysis study aims to evaluate the Diabetes Self-Management Education and Support (DSMES) online application for reducing glycated hemoglobin levels among patients with type 1 diabetes mellitus (T1DM) patients.

Main text: The Web of Science (WoS), Cochrane Library, PubMed, Scopus, PROSPERO, and EMBASE databases were searched with Medical Subject Headings (MeSH) terms without minimum time limitation until February 2024. To be eligible, all the following predefined inclusion criteria must have been met in the original randomized controlled trial (RCT) studies without language limitation including T1DM, patients, online digital interventions such as web-based, mobile health applications, or e-health, 3 or more months follow-up, and measuring HbA1c. Finally, 10 studies were conducted, 1195 T1DM patients were included in this study of which 421 (35.2%) were adults and 774 (64.8%) were adolescents. Overall, the mean differences for HbA1c at 6 months between baseline and follow-up groups was 0.27% (-0.76, 1.31) (P < 0.001) in adultescents and 0.92% (0.34, 1.5) (P < 0.001) in adults. Moreover, the mean differences for HbA1c at 12 months between baseline and follow-up groups was - 0.02% (-0.31, 0.26) (P = 0.85) in adults.

Conclusions: Online DSME is effective in improving the glycemic control of adults and adultescents individuals with T1DM for reducing HbA1c while maintaining this important factor at an appropriate dose.

Background: The management of diabetic foot osteomyelitis (DFO) is complex. The targeted use of adjuvant local antibiotics, in the form of biocomposite bone void filler, in DFO, can enhance patient outcomes while minimising the adverse effects associated with systemic antibiotic therapy and its shortcomings.

Methods: We reviewed a series of 105 consecutive patients who underwent surgical management for diabetic foot osteomyelitis. In the NLAB group, (no adjuvant local antibiotic use), 49 patients, received the current standard of care treatment with no use of adjunctive local antibiotic therapy. In group LAB, (adjuvant use of local antibiotics), 56 patients received additional adjuvant local antibiotic therapy. Patient outcomes were compared between both groups.

Results: Infection healing was demonstrated in 10 (20.41%) patients from group NLAB and 41 (73.21%) from group LAB (p < 0.0001). Persistence of infection with no evidence of wound healing, 6 months from surgery, was observed in 15 (30.61%) patients in group NLAB. Among the LAB group, only 4 (7.14%) patients demonstrated infection persistence (p = 0.00183). Reinfection was observed in 24 of 49 patients in group NLAB (49%) and in only 11 out of 56 patients in group LAB (20%) (p = 0.001466). 7 (6.67%) patients required major amputation with 6 (12.24%) belonging to group NLAB. Only 1 (1.78%) patient in group LAB underwent major amputation. A higher 5-year mortality rate was noted within patients in group NLAB, 27 (55.1%). The mortality rate in group LAB was (12.5%).

Conclusion: The adjuvant use of antibiotic loaded bio-composite bone void filler locally was associated with increased infection clearance rates regarding diabetic foot osteomyelitis when compared with the standard care of treatment while achieving lower rates of infection persistence and recurrence. It also has the potential to reduce amputation and mortality rates with further research.

Objective: This study aimed to determine the prevalence of Normal Weight Obesity (NWO) and evaluate its association with cardiometabolic risk factors among patients with Type 2 Diabetes Mellitus (T2DM) in Gujarat, India.

Methods: This cross-sectional study included 432 adults with T2DM attending a Non-Communicable Disease clinic. Anthropometric measurements, body composition analysis using bioelectrical impedance, and clinical parameters were assessed. NWO was defined as normal BMI (18.5-24.9 kg/m²) with high body fat percentage (≥ 25% for men, ≥ 32% for women). Cardiometabolic risk factors, including blood glucose, blood pressure, and lipid profile, were evaluated. Statistical analyses included descriptive statistics, correlation analysis, and multivariate logistic regression.

Results: The prevalence of NWO was 33% among the study population. Significant discordance was observed between BMI classification and body fat percentage, with 91% of males and 51.8% of females with normal BMI having obese levels of body fat. Individuals with NWO demonstrated higher cardiometabolic risk profiles compared to non-obese counterparts, including elevated random blood glucose levels (290 ± 110 mg/dL vs. 180 ± 80 mg/dL, p < 0.001), higher systolic (148.8 ± 25.4 mmHg vs. 122.5 ± 19.5 mmHg, p < 0.001) and diastolic blood pressure (98.5 ± 55.6 mmHg vs. 78.6 ± 36.6 mmHg, p < 0.001), and increased prevalence of hypertension (61% vs. 15%, p < 0.001). A moderate positive correlation was found between body fat percentage and random blood sugar levels (r = 0.504, p < 0.001). Multivariate analysis identified age, duration of diabetes, blood glucose levels, and blood pressure as independent factors associated with NWO.

Conclusion: The high prevalence of NWO and its significant association with adverse cardiometabolic risk factors in T2DM patients underscores the limitations of using BMI alone for obesity assessment. These findings highlight the need for incorporating body composition analysis in routine clinical practice to improve risk stratification and management strategies in T2DM patients, particularly in the Asian Indian population.

Background: Metabolic-associated fatty liver disease (MAFLD) is a major public health problem worldwide. This study aimed to determine the prevalence of MAFLD and evaluate the diagnostic accuracy of the Fatty Liver Index (FLI) compared to ultrasonography for detecting fatty liver in adults attending a tertiary care hospital in Gujarat, India.

Methods: This cross-sectional study included 500 adults visiting the outpatient department between January 2023 and December 2023. MAFLD was diagnosed on ultrasound. FLI was calculated using body mass index, waist circumference, triglycerides, and gamma-glutamyl transpeptidase levels. FLI ≥ 60 indicated fatty liver. Logistic regression analysis identified factors associated with fatty liver.

Results: MAFLD prevalence was 32.2% on ultrasound. High FLI (≥ 60) was present in 26.2%. Male sex, higher BMI, waist circumference, night shift work, diabetes, and triglycerides were independent predictors of fatty liver. FLI showed excellent diagnostic accuracy with a sensitivity of 96%, specificity of 92.5%, and AUC of 0.92 for detecting fatty liver on ultrasound.

Conclusion: MAFLD prevalence among adults was high in this hospital-based sample. FLI can serve as an accurate non-invasive tool for identifying individuals with a high probability of MAFLD. These findings emphasize the need for larger population-based studies and the implementation of regular MAFLD screening programs in high-risk groups.

Background: The literature has been evolving to standardize gestational diabetes mellitus (GDM) diagnosis and terminology. The significance of timing in diagnosing hyperglycemia during pregnancy is underlined by evidence that women diagnosed at 24 weeks of gestation or earlier are at a higher risk of developing postpartum prediabetes, but its association with adverse outcomes for the newborn is controversial. We aimed to investigate the association between early-onset GDM and adverse outcomes in newborns and neonates, comparing it with the late-onset GDM model.

Methods: It was a retrospective cohort study conducted at the Perinatal Diabetes Research Center in Assis/SP, affiliated with the Botucatu Medical School-UNESP in Brazil. The group composition was as follows: early-onset participants had fasting glucose levels ≥ 92 mg/dL and < 126 mg/dL before 20 weeks of gestation, while late-onset participants had a negative first-trimester screening and a positive 75g-OGTT at 24-28 weeks. For early-onset GDM, a fasting glucose level of ≥ 92 mg/dL is a recognized threshold associated with an increased risk of adverse pregnancy outcomes, while < 126 mg/dL ensures the exclusion of overt diabetes. The criteria for late-onset GDM, involving a negative initial screening and a positive OGTT at 24-28 weeks, align with the standard diagnostic timeframe when insulin resistance typically peaks due to placental hormone secretion. The maternal baseline characteristics included pre-pregnancy body mass index (BMI; kg/m2) and pregnancy weight gain (kg), calculated as the difference between the final pregnancy weight (36 gestational weeks or more) and pre-pregnancy maternal weight, classified according to the pre-pregnancy BMI. Additionally, the perinatal outcomes evaluated in this study included gestational age (GA) at birth, birth weight (BW) categorized according to GA as adequate, large, or small and Apgar scores at the first and 5th minutes.

Results: Eight hundred eighty pregnant women were selected, of whom 203 (23.07%) presented GDM and were eligible from December 2016 to December 2021. Based on the timing onset of GDM, 89 (43.8%) were in the early-onset group, and 114 (56.2%) were in the late-onset group. The fasting plasma glucose values in the first trimester were higher in the early-onset group. The 75-g OGTT values were higher in the late-onset group. The final BMI was higher in the early-onset group. Univariate linear regression was performed to determine the relationship between late-onset and maternal and neonatal outcomes; however, no significant relation was detected.

Conclusion: Pregnant women with early-onset GDM showed a higher BMI during pregnancy, but there was no difference between early and late-onset GDM concerning neonatal adverse outcomes.

Objective: To evaluate the specular microscopy findings in patients with diabetes mellitus (DM) through a systematic review and meta-analysis.

Methods: A systematic search with the appropriate keyword was done in the online databases including PubMed, Scopus, and Web of Sciences. The records were imported into EndNote software and duplicated records were removed. The title, abstract, and full text of the articles were evaluated carefully. STATA software also was used for all data analyses. The mean difference (MD) and 95% confidence intervals (95% CIs) were used to examine the data.

Results: After a systematic search, 781 records were evaluated and finally, 14 of them were selected for final analysis. The results showed that the mean differences in average cell size (MD = 21.22, 95% CI 10.43, 32.01, P 0.001), central corneal thickness (MD = 9.90, 95% CI 6.07, 13.73, P 0.001), and coefficient of variation (MD = 1.11, 95% CI 0.11, 2.11, P = 0.03) were higher in diabetic patients in comparison with healthy cases. However, the mean differences in endothelial cell density (MD = -114.29, 95% CI -158.34, -70.24, P 0.001) and hexagonal cell ratio (MD = -3.52, 95% CI -5.79, -1.25, P < 0.001) were lower in diabetic cases.

Conclusions: Patients with DM have higher average cell size, corneal thickness, and coefficient of variation. On the other hand, the endothelial cell density and hexagonal cell ratio were reduced in diabetic cases.

Background: Diabetes distress "refers to the negative emotional or affective experiences resulting from the challenge of living with the demands of diabetes." Despite recommendations to screen for distress at regular intervals, it usually remains undiagnosed. This study aimed to determine the prevalence of diabetes distress among adults living with diabetes, determine the factors associated with distress, the association between selfcare and distress, glycemic control and distress and compare the health-related quality of life among those with and without distress.

Methods: This cross-sectional, community-based study was conducted in an urban colony in Delhi, India. The participants were selected using simple random sampling and included adults diagnosed with diabetes mellitus. The sample size calculated was 390. The questionnaire included the Diabetes Distress Scale 17, Diabetes Self-Management Questionnaire and Healthy Days measure. Factors associated with distress were tested using bivariate followed by multivariable logistic regression. Multivariable logistic regression was used to find the association between selfcare and distress and glycemic control and distress. Mean number of unhealthy days and health rating were compared between distressed and non-distressed diabetics using Wilcoxon rank sum test and chi square test respectively.

Results: A total of 412 adults were included in the study, of which 35.4% had clinically significant distress. Female sex, low socio-economic status, 1 or more comorbidities, diagnosis of diabetes 10 or more years prior, being on treatment and an unmet need for social support were the factors found to be associated with distress. There was a positive association between physicians contact and distress. Those with poor glycemic control had higher odds of distress. There was a significant difference in the health reported by those with and without distress (p < 0.001). Those with distress also suffered from significantly more physically unhealthy days and mentally unhealthy days than those without distress (p < 0.001).

Conclusion: In this study, more than one in three diabetics were found to be distressed. Healthcare providers should increase their focus on the psychological aspects of diabetes and improve their communication with patients. Diabetes distress needs to be screened for in routine clinical settings and addressed appropriately.

Background: Type 2 diabetes mellitus (T2DM) is a major global non-communicable disease, leading to increased morbidity and mortality. Its prevalence in Nigeria is driven by various risk factors. This review assesses the national and regional prevalence and risk factors of T2DM in Nigeria.

Methods: Following PRISMA guidelines, electronic databases (PubMed, Scopus, Google Scholar, African Journals Online) and gray literature were searched for English-language studies. The quality of the included studies was assessed using the Newcastle-Ottawa Scale. Data were extracted with Microsoft Excel and analyzed using Stata version 16 software. Random effect meta-regression analysis at 95% CI was used to assess pooled prevalence and risk factors. Heterogeneity was determined using the I² statistic, and publication bias was evaluated with a funnel plot.

Results: Sixty studies from different Nigerian geopolitical zones met eligibility criteria, with a total sample size of 124,876 participants and a mean age of 48 ± 9.8 years. The pooled prevalence of T2DM in Nigeria was 7.0% (95% CI: 5.0-9.0%). Moderate publication bias was observed. The South-south zone had the highest prevalence at 11.35% (95% CI: 4.52-20.72%), while the North-central zone had the lowest at 2.03% (95% CI: 1.09-3.40%). Significant risk factors included family history (9.73), high socioeconomic status (6.72), physical inactivity (5.92), urban living (4.79), BMI > 25/m² (3.07), infrequent vegetable consumption (2.68), and abdominal obesity (1.81).

Conclusion: The prevalence of T2DM in Nigeria (7.0%) nearly doubled the 2019 International Diabetes Federation estimate (3.7%) and shows a 21.3% increase from the 2019 review. Efforts should focus on modifying identified risk factors to reduce prevalence and prevent complications.