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Common Limitations and Challenges of Dietary Clinical Trials for Translation into Clinical Practices. 饮食临床试验转化为临床实践的常见限制和挑战。
IF 2.1 Q3 Medicine Pub Date : 2021-05-01 eCollection Date: 2021-07-01 DOI: 10.5812/ijem.108170
Parvin Mirmiran, Zahra Bahadoran, Zahra Gaeini

The progressive development of clinical and public health nutrition has long relied on dietary clinical trials (DCTs), investigating the causal relationship between diet and multiple risk factors of non-communicable and chronic diseases. DCTs are also hallmarks for establishing dietary requirements and promoting overall nutritional health among the population. Despite their critical importance in translation into public health strategies and practices, DCTs have several limitations and challenges for study design, implementation and finding interpretation. The complex nature of nutrition interventions, collinearity between diet components, multi-target effects of the interventions, diverse dietary behaviors, and food culture are the most challenging issues. Furthermore, baseline exposure and dietary status, appropriate control groups, blinding, randomization, and poor adherence undermine the effectiveness of DCTs in translation into practices. Disruptive factors will be minimized if researchers are committed to following good clinical practice (GCP) standards available for common designs of clinical trials. Planning DCTs, however, needs careful considerations for hypothesis generation, study design development, the definition of primary and secondary outcome measures, and target population.

长期以来,临床和公共卫生营养学的逐步发展一直依赖于膳食临床试验(dct),研究饮食与非传染性疾病和慢性疾病的多种危险因素之间的因果关系。dct也是确定膳食需求和促进人口整体营养健康的标志。尽管dct在转化为公共卫生战略和实践方面至关重要,但在研究设计、实施和寻找解释方面存在一些限制和挑战。营养干预的复杂性、饮食成分之间的共线性、干预的多目标效应、多样化的饮食行为和饮食文化是最具挑战性的问题。此外,基线暴露和饮食状况、适当的对照组、盲法、随机化和依从性差都会破坏dct转化为实践的有效性。如果研究人员致力于遵循临床试验通用设计的良好临床实践(GCP)标准,破坏性因素将被最小化。然而,规划dct需要仔细考虑假设的产生、研究设计的发展、主要和次要结果测量的定义以及目标人群。
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引用次数: 27
Evidence Gap and Knowledge Map of Physical Activity Research in Diabetes in Iran: A Scoping Review. 伊朗糖尿病身体活动研究的证据缺口和知识图谱:范围综述。
IF 2.1 Q3 Medicine Pub Date : 2021-04-27 eCollection Date: 2021-04-01 DOI: 10.5812/ijem.110636
Mahnaz Sanjari, Shahnaz Esmaeili, Hossein Yarmohammadi, Rasha Atlasi, Maryam Aalaa, Bagher Larijani, Ensieh Nasli-Esfahani

Context: The important role of physical activity in the prevention and management of diabetes necessitates a review of current research to shed light on gaps in national diabetes guidelines.

Evidence acquisition: This scoping review was part of the Iran Diabetes Research Roadmap (IDRR) study. A systematic search was used based on the Arksey and O'Malley method consisting of six steps. The descriptive analysis was done with SPSS software. Additionally, VOS veiwer software was used to draw the knowledge map of the included studies.

Results: There were 169 articles included from the beginning of 2015 to the end of 2019 in Iran. Aerobic and resistance exercises were types of physical activity with more number of articles. Most of the included clinical studies were randomized clinical trials and had a level of evidence two. Also, there was more interest in outcomes such as glycemic control and insulin sensitivity, metabolic syndrome, metabolism, and cardiovascular health. The network of co-authorship was drawn, and "controlled study", "male", and "rat" were the most frequent keywords.

Conclusions: The number of Iranian diabetes researchers on physical activity is increasing, and the majority of clinical studies had a high level of evidence. With maintaining previous interests and investigations, there should be more emphasis on research in elderly and children age groups as evidence gap in Iran. Also, longitudinal cohort studies should be highlighted and Iranian researchers should be encouraged to participate in new topics of research worldwide.

背景:体育活动在糖尿病预防和管理中的重要作用,需要对当前的研究进行审查,以阐明国家糖尿病指南中的差距。证据获取:本综述是伊朗糖尿病研究路线图(IDRR)研究的一部分。采用了基于Arksey和O'Malley方法的系统搜索,包括六个步骤。描述性分析采用SPSS软件。此外,采用VOS viewer软件绘制纳入研究的知识图谱。结果:2015年初至2019年底,伊朗共纳入文献169篇。有氧运动和阻力运动是文章数量较多的体育活动类型。大多数纳入的临床研究为随机临床试验,证据等级为二级。此外,人们对血糖控制和胰岛素敏感性、代谢综合征、新陈代谢和心血管健康等结果更感兴趣。绘制了合作作者网络,“对照研究”、“男性”和“老鼠”是最常见的关键词。结论:伊朗糖尿病研究人员对身体活动的研究人数正在增加,并且大多数临床研究具有高水平的证据。在保持原有兴趣和调查的同时,应更加重视对老年人和儿童年龄组的研究,作为伊朗的证据缺口。此外,应强调纵向队列研究,并应鼓励伊朗研究人员参与世界范围内的新研究课题。
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引用次数: 1
Iranian National Clinical Practice Guideline for Exercise in Patients with Diabetes. 伊朗国家糖尿病患者运动临床实践指南。
IF 2.1 Q3 Medicine Pub Date : 2021-04-26 eCollection Date: 2021-07-01 DOI: 10.5812/ijem.109021
Mohammad Hassabi, Alireza Esteghamati, Farzin Halabchi, Amir Hosein Abedi-Yekta, Behnaz Mahdaviani, Bahar Hassanmirzaie, Farhad Hosseinpanah, Majid Valizadeh

Context: Growing evidence highlights the importance of physical activity as a critical element for the prevention and control of diabetes. However, there is no clinical practice guideline focusing on the different aspects of exercise in patients with diabetes, especially for the Iranian population.

Objective: We aimed to prepare and adopt a clinical practice guideline to provide well-defined, simple, and concise responses to certain questions related to physical activity and exercise in all patients with diabetes, including type 1, 2, and gestational diabetes mellitus (GDM).

Evidence acquisition: A multidisciplinary team of experts in various fields (sports medicine specialists, endocrinologists, and cardiologists) developed the guideline. This group did the task in four stages: (1) identifying and refining the subject area using 17 clinical questions; (2) appraising evidence through a systematic review of the literature; (3) extracting recommendations from evidence and grading them as A, B, C, or D based on the quality, quantity, and consistency of existing evidence; and (4) subjecting the guideline to external review and finally selecting the recommendations with high scores of appropriateness and agreement. The final version was evaluated and approved by the National Deputy for Curative Affairs - Ministry of Health and Medical Education and has also been endorsed by the Iran Endocrine Society (IES) and Iranian Association of Sports and Exercise Medicine (IASEM).

Results: The guideline consists of 52 recommendations addressing 17 important questions concerning different aspects of exercise prescription in Iranian patients with diabetes.

Conclusions: The guideline provides evidence-based information that may help physicians to prescribe exercise for Iranian patients with diabetes safely and effectively.

背景:越来越多的证据强调了身体活动作为预防和控制糖尿病的关键因素的重要性。然而,没有临床实践指南关注糖尿病患者运动的不同方面,特别是针对伊朗人群。目的:我们旨在制定并采用一项临床实践指南,为所有糖尿病患者(包括1型、2型和妊娠期糖尿病(GDM))的身体活动和锻炼相关的某些问题提供明确、简单和简明的回答。证据获取:由不同领域的专家(运动医学专家、内分泌学家和心脏病学家)组成的多学科团队制定了指南。这个小组分四个阶段完成任务:(1)用17个临床问题确定和完善主题领域;(2)通过对文献的系统回顾来评价证据;(3)从证据中提取建议,并根据现有证据的质量、数量和一致性将其分为A、B、C或D;(4)对指南进行外部评审,最终选择适当性和一致性得分较高的建议。最终版本由国家医疗事务副主管——卫生和医学教育部进行了评估和批准,并得到了伊朗内分泌学会(IES)和伊朗体育和运动医学协会(IASEM)的认可。结果:该指南包括52条建议,涉及伊朗糖尿病患者运动处方不同方面的17个重要问题。结论:该指南提供了基于证据的信息,可以帮助医生安全有效地为伊朗糖尿病患者开运动处方。
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引用次数: 3
Subcutaneous Calcification and Fixed Flexion Deformity of the Right Elbow Joint in a Child with a GNAS Mutation: A Case Report. GNAS突变儿童右肘关节皮下钙化和固定屈曲畸形1例报告。
IF 2.1 Q3 Medicine Pub Date : 2021-04-19 eCollection Date: 2021-04-01 DOI: 10.5812/ijem.110792
Hussain Alsaffar, Najya Attia, Senthil Senniappan

Introduction: The art of medicine glorifies when a clinician listens carefully to the patient's story, gives a thorough examination, performs appropriate investigations, and finally links findings together to reach a definite diagnosis. An interesting case was reported here, highlighting the integration of different symptoms and manifestations with some relevant biochemical investigations to reach a final diagnosis. To the best of our knowledge, fixed flexion deformity, as a complication of subcutaneous calcification, has not been previously reported in a child with Albright hereditary osteodystrophy (AHO).

Case presentation: A 2.5-year-old boy was born at term with a birth weight of 3.5 kg (-0.49 SDS). The child was referred to a general pediatrician with a history of right elbow joint swelling noticed initially at six months of age. He then developed the limitation of right upper arm movement, which slowly progressed afterward. The patient had no history of trauma. At nine months of age, he was diagnosed with hypothyroidism, preceded by cold skin, dry hair, and constipation. At nine years of age, he presented with a fixed flexion deformity of the right elbow associated with markedly limited joint movement and symmetrical hands with hyperpigmented knuckles of right metacarpal bones. Subcutaneous masses were felt along the right forearm, showing tenderness on palpation. Investigations revealed elevated serum parathyroid hormone and normal calcium indicating parathyroid hormone resistance. Further genetic testing revealed GNAS mutation. The child was obese throughout his childhood.

Conclusions: This case report describes an obese child with subcutaneous calcification that led to fixed flexion deformity of the elbow, starting at an incredibly early age. Hypothyroidism and pseudohypoparathyroidism raised the suspicion of AHO, which was later confirmed by genetic testing. This is the first case report on fixed flexion deformity in a patient with GNAS mutation (c.719-1G > A Chr20: 57484737) in West Asia.

导言:当临床医生仔细倾听病人的故事,进行彻底的检查,进行适当的调查,并最终将结果联系在一起以达到明确的诊断时,医学艺术就会得到赞美。这里报告了一个有趣的病例,强调将不同的症状和表现与一些相关的生化检查相结合,以达到最终诊断。据我们所知,固定屈曲畸形作为皮下钙化的并发症,在患有奥尔布赖特遗传性骨营养不良(who)的儿童中尚未见报道。病例介绍:一名2.5岁男孩足月出生,出生体重为3.5 kg (-0.49 SDS)。该患儿在6个月大时发现右肘关节肿胀,并被转介给普通儿科医生。随后出现右上臂活动受限,此后病情缓慢好转。患者无外伤史。9个月大时,他被诊断为甲状腺功能减退症,并伴有皮肤冰冷、头发干燥和便秘。9岁时,患者出现右肘固定屈曲畸形,关节活动明显受限,双手对称,右掌骨指关节色素沉着。右前臂皮下肿块,触诊有压痛。调查显示血清甲状旁腺激素升高,钙正常,提示甲状旁腺激素抵抗。进一步基因检测显示GNAS突变。这个孩子整个童年都很肥胖。结论:本病例报告描述了一个肥胖儿童,皮下钙化导致肘关节固定屈曲畸形,开始于令人难以置信的早期。甲状旁腺功能减退和假性甲状旁腺功能减退引起了世卫组织的怀疑,后来通过基因检测得到证实。这是西亚第一例GNAS突变(c.719-1G > a Chr20: 57484737)患者的固定屈曲畸形病例报告。
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引用次数: 0
Accuracy of Urinary Etiocholanolone/Androsterone Ratio as Alternative to Serum Testosterone/Dihydrotestosterone Ratio for Diagnosis of 5 Alpha-reductase Type 2 Deficiency Patients and Carriers in Indonesia. 尿Etiocholanolone/Androsterone比值替代血清睾酮/双氢睾酮比值诊断印度尼西亚5例α -还原酶2型缺乏患者和携带者的准确性
IF 2.1 Q3 Medicine Pub Date : 2021-04-18 eCollection Date: 2021-04-01 DOI: 10.5812/ijem.109510
Nanis Sacharina Marzuki, Firman Pratama Idris, Hannie Kartapradja, Shirley Renata, Alida Harahap, Jose Rizal Latief Batubara
Background The 5 Alpha-reductase type 2 deficiency (5ARD2) is an inherited condition, which clinically presents as variable degrees of under virilization in affected 46,XY individuals. In the diagnostic pathway of 5ARD2, the testosterone/dihydrotestosterone (T/DHT) ratio is broadly employed before molecular analysis of the SRD5A2 gene. However, due to cost-benefit considerations, the DHT test in our country is routinely lacking in clinical settings; therefore, we considered applying the urinary etiocholanolone/androsterone (Et/An) ratio as an alternative test. Objectives We aimed to determine the diagnostic value of the urinary Et/An ratio versus the T/DHT ratio in diagnosing 5ARD2 patients and carriers. Methods Sixty-six suspected 5ARD2 46,XY disorders of sex development (DSD) individuals and 95 family members were recruited in the study. Their clinical manifestations, T/DHT and urinary Et/An ratios, and SRD5A2 genes were analyzed. Using molecular analysis of the SRD5A2 gene as the gold standard, we compared the accuracy of both ratios in diagnosing 5ARD2 patients and carriers with receiver operating characteristic (ROC) curve analysis. Results Thirty-seven patients were confirmed molecularly to have 5ARD2, and the rest (n = 29) were assessed as normal controls, while in the carrier group, 53 were molecularly confirmed as carriers and 42 as controls. The AUCs (areas under the curve) of the T/DHT and urinary Et/An ratios were 57.7% (95% CI 43.0 - 72.4%, P > 0.05) and 79.7% (95% CI 69.0 - 90.4%, P < 0.001), respectively, in diagnosing 5ARD2 patients and 54.1% (95% CI 42.4 - 65.8%, P > 0.05) and 75.1% (95% CI 65.1 - 85.1%, P < 0.001), respectively, in diagnosing carriers. The cutoff value of the urinary Et/An ratio was set at ≥ 0.95 for detecting 5ARD2 patients and ≥ 0.99 for detecting carriers. Conclusions The testosterone/DHT ratio was inaccurate in diagnosing 5ARD2 patients. When molecular analysis for the SRD5A2 gene is lacking, the urinary Et/An ratio may be a useful test to diagnose 5ARD2 patients and carriers.
背景:5α -还原酶2型缺乏症(5ARD2)是一种遗传性疾病,临床表现为46,xy患者不同程度的低男性化。在5ARD2的诊断途径中,在对SRD5A2基因进行分子分析之前,广泛采用睾酮/双氢睾酮(T/DHT)比值。然而,由于成本效益的考虑,DHT检测在我国通常缺乏临床设置;因此,我们考虑采用尿etiocholanolone/androsterone (Et/An)比值作为替代测试。目的:我们旨在确定尿Et/An比与T/DHT比在诊断5ARD2患者和携带者中的诊断价值。方法:招募66例疑似5ard46、XY性发育障碍(DSD)患者及95名家庭成员。分析患者的临床表现、T/DHT、尿Et/An比值及SRD5A2基因。以SRD5A2基因分子分析为金标准,采用受试者工作特征(ROC)曲线分析比较两种比值诊断5ARD2患者和携带者的准确性。结果:分子确诊5ARD2患者37例,其余29例为正常对照组,携带者组53例为携带者,对照组42例。诊断5ARD2患者T/DHT和尿Et/An比值的auc(曲线下面积)分别为57.7% (95% CI 43.0 ~ 72.4%, P > 0.05)和79.7% (95% CI 69.0 ~ 90.4%, P < 0.001),诊断携带者分别为54.1% (95% CI 42.4 ~ 65.8%, P > 0.05)和75.1% (95% CI 65.1 ~ 85.1%, P < 0.001)。5ARD2患者尿Et/An比值临界值≥0.95,携带者尿Et/An比值临界值≥0.99。结论:睾酮/DHT比值在诊断5ARD2患者时是不准确的。当缺乏SRD5A2基因的分子分析时,尿Et/An比值可能是诊断5ARD2患者和携带者的有用测试。
{"title":"Accuracy of Urinary Etiocholanolone/Androsterone Ratio as Alternative to Serum Testosterone/Dihydrotestosterone Ratio for Diagnosis of 5 Alpha-reductase Type 2 Deficiency Patients and Carriers in Indonesia.","authors":"Nanis Sacharina Marzuki,&nbsp;Firman Pratama Idris,&nbsp;Hannie Kartapradja,&nbsp;Shirley Renata,&nbsp;Alida Harahap,&nbsp;Jose Rizal Latief Batubara","doi":"10.5812/ijem.109510","DOIUrl":"https://doi.org/10.5812/ijem.109510","url":null,"abstract":"Background The 5 Alpha-reductase type 2 deficiency (5ARD2) is an inherited condition, which clinically presents as variable degrees of under virilization in affected 46,XY individuals. In the diagnostic pathway of 5ARD2, the testosterone/dihydrotestosterone (T/DHT) ratio is broadly employed before molecular analysis of the SRD5A2 gene. However, due to cost-benefit considerations, the DHT test in our country is routinely lacking in clinical settings; therefore, we considered applying the urinary etiocholanolone/androsterone (Et/An) ratio as an alternative test. Objectives We aimed to determine the diagnostic value of the urinary Et/An ratio versus the T/DHT ratio in diagnosing 5ARD2 patients and carriers. Methods Sixty-six suspected 5ARD2 46,XY disorders of sex development (DSD) individuals and 95 family members were recruited in the study. Their clinical manifestations, T/DHT and urinary Et/An ratios, and SRD5A2 genes were analyzed. Using molecular analysis of the SRD5A2 gene as the gold standard, we compared the accuracy of both ratios in diagnosing 5ARD2 patients and carriers with receiver operating characteristic (ROC) curve analysis. Results Thirty-seven patients were confirmed molecularly to have 5ARD2, and the rest (n = 29) were assessed as normal controls, while in the carrier group, 53 were molecularly confirmed as carriers and 42 as controls. The AUCs (areas under the curve) of the T/DHT and urinary Et/An ratios were 57.7% (95% CI 43.0 - 72.4%, P > 0.05) and 79.7% (95% CI 69.0 - 90.4%, P < 0.001), respectively, in diagnosing 5ARD2 patients and 54.1% (95% CI 42.4 - 65.8%, P > 0.05) and 75.1% (95% CI 65.1 - 85.1%, P < 0.001), respectively, in diagnosing carriers. The cutoff value of the urinary Et/An ratio was set at ≥ 0.95 for detecting 5ARD2 patients and ≥ 0.99 for detecting carriers. Conclusions The testosterone/DHT ratio was inaccurate in diagnosing 5ARD2 patients. When molecular analysis for the SRD5A2 gene is lacking, the urinary Et/An ratio may be a useful test to diagnose 5ARD2 patients and carriers.","PeriodicalId":13969,"journal":{"name":"International Journal of Endocrinology and Metabolism","volume":null,"pages":null},"PeriodicalIF":2.1,"publicationDate":"2021-04-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/88/8c/ijem-19-2-109510.PMC8198621.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"39249535","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}
引用次数: 1
The Association Between Male Infertility and Cardiometabolic Disturbances: A Population-Based Study. 男性不育与心脏代谢紊乱之间的关系:一项基于人群的研究。
IF 2.1 Q3 Medicine Pub Date : 2021-04-13 eCollection Date: 2021-04-01 DOI: 10.5812/ijem.107418
Samira Behboudi-Gandevani, Razieh Bidhendi Yarandi, Marzieh Rostami Dovom, Fereidoun Azizi, Fahimeh Ramezani Tehrani

Background: Further studies are needed to extend our knowledge about the association between male infertility and cardio-metabolic disorders.

Objectives: We aimed to assess the association between male infertility and cardiometabolic disturbances using a population-based design.

Methods: In total, 1611 participants of the Tehran-Lipid and Glucose-Study (phase III) were categorized into two groups of men with documented male infertility (n = 88) and those with at least one live birth and no history of primary infertility (n = 1523). Logistic regression was applied to explore the association between male infertility and cardiometabolic disturbances, including diabetes mellitus, pre-diabetes, hypertension, metabolic syndrome, dyslipidemia, obesity, central obesity, and chronic kidney disease, following adjustment for age and body mass index (BMI).

Results: The unadjusted model revealed a significant association between infertility and hypertension and CKD (OR = 1.8; 95% CI: 1.2, 2.9, P-value = 0.006 and OR = 1.9; 95% CI: 1.1, 3.6, P-value = 0.033), respectively. However, after adjusting for age and BMI, as potential confounders, this association was not significant. Moreover, there was no association between infertility and other cardiometabolic disturbances, including diabetes and pre-diabetes, metabolic syndrome, dyslipidemia, obesity, and central obesity in both unadjusted and adjusted models.

Conclusions: Our study revealed no association between male infertility and cardiometabolic disturbances. The findings can pave the way for further studies to extend our knowledge in this field. More population-based studies with a large sample size are warranted to confirm these findings.

背景:需要进一步的研究来扩大我们对男性不育与心脏代谢紊乱之间关系的认识。目的:我们旨在通过基于人群的设计评估男性不育与心脏代谢紊乱之间的关系。方法:1611名德黑兰血脂和血糖研究(III期)的参与者被分为两组,一组有男性不育症(n = 88),另一组至少有一次活产且无原发性不育症史(n = 1523)。在调整年龄和体重指数(BMI)后,应用Logistic回归探讨男性不育与心脏代谢紊乱(包括糖尿病、糖尿病前期、高血压、代谢综合征、血脂异常、肥胖、中枢性肥胖和慢性肾脏疾病)之间的关系。结果:未经调整的模型显示不孕症与高血压和CKD之间存在显著相关性(OR = 1.8;95% CI: 1.2, 2.9, p值= 0.006,OR = 1.9;95% CI: 1.1, 3.6, p值= 0.033)。然而,在调整了年龄和BMI(作为潜在的混杂因素)后,这种关联并不显著。此外,在未调整和调整的模型中,不孕症与其他心脏代谢紊乱(包括糖尿病和糖尿病前期、代谢综合征、血脂异常、肥胖和中心性肥胖)之间没有关联。结论:我们的研究显示男性不育和心脏代谢紊乱之间没有关联。这些发现可以为进一步的研究铺平道路,以扩展我们在这一领域的知识。需要更多基于人群的大样本量研究来证实这些发现。
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引用次数: 7
Association Between Serum Nitric Oxide Level and Changes in Thyroid Function Test in a Population-based Study: Tehran Thyroid Study Participants (TTS). 在一项基于人群的研究中,血清一氧化氮水平与甲状腺功能测试变化之间的关系:德黑兰甲状腺研究参与者(TTS)。
IF 2.1 Q3 Medicine Pub Date : 2021-03-28 eCollection Date: 2021-07-01 DOI: 10.5812/ijem.109214
Behnaz Ghazisaeidi, Farzaneh Sarvghadi, Asghar Ghasemi, Maryam Tohidi, Fereidoun Azizi, Atieh Amouzegar

Background: Nitric oxide (NO) plays a key role in thyroid function regulation through the inhibition of iodide (I) uptake at the thyroidal sodium-iodide symporter (NIS) and impacts on the thyroid vascularity and blood flow.

Objectives: This study aimed to evaluate the association between serum NO metabolites (NOx) and thyroid-stimulating hormone (TSH), free thyroxin (FT4), and anti-thyroid peroxidase (TPOAb) changes. Also, it aimed at evaluating the correlation between serum NOx and the incidence of clinical hypothyroidism, characterized by elevated TSH level and decreased FT4 concentration, and subclinical hypothyroidism, characterized by mildly elevated TSH level despite FT4 concentration within the normal range, over three years of follow-up.

Methods: This study included 1,137 participants of the Tehran Thyroid study (TTS), aged > 20 years old, for whom data on serum TSH, FT4, and TPOAb in the third and fourth phases, and serum NOx in the third phase were available. Changes in TSH (ΔTSH), FT4 (ΔFT4), and TPOAb (ΔTPO) between the third and fourth phases were calculated, and the associations between serum NOx and ΔTSH, ΔFT4, and ΔTPOAb were assessed after multivariable adjustment using linear regression analysis.

Results: No significant association was found between serum NOx and ΔTSH, ΔFT4, and ΔTPOAb after the multivariable adjustment; neither was any observed in TPOAb split groups after multivariable adjustment. No significant association was found between serum NOx tertiles and clinical and subclinical hypothyroidism incidence in the fourth phase of TTS.

Conclusions: There was no association between serum NOx levels and changes in TSH, FT4, and TPOAb and clinical and subclinical hypothyroidism incidence.

背景:一氧化氮(NO)通过抑制甲状腺碘化钠同调体(NIS)对碘(I)的摄取以及对甲状腺血管和血流的影响,在甲状腺功能调节中起关键作用。目的:本研究旨在探讨血清NO代谢物(NOx)与促甲状腺激素(TSH)、游离甲状腺素(FT4)、抗甲状腺过氧化物酶(TPOAb)变化的关系。同时,通过3年的随访,评估血清NOx与临床甲状腺功能减退(以TSH水平升高、FT4浓度降低为特征)和亚临床甲状腺功能减退(以FT4浓度在正常范围内但TSH水平轻度升高为特征)发生率的相关性。方法:本研究纳入了德黑兰甲状腺研究(TTS)的1137名年龄> 20岁的参与者,他们在第三期和第四期的血清TSH、FT4和TPOAb以及第三期的血清NOx数据。计算第三期和第四期TSH (ΔTSH)、FT4 (ΔFT4)和TPOAb (ΔTPO)的变化,并通过线性回归分析进行多变量调整后评估血清NOx与ΔTSH、ΔFT4和ΔTPOAb的相关性。结果:经多变量调整后,血清NOx与ΔTSH、ΔFT4、ΔTPOAb无显著相关性;经多变量校正后,TPOAb分裂组均未见异常。血清NOx含量与TTS第四期临床和亚临床甲状腺功能减退发生率无显著相关性。结论:血清NOx水平与TSH、FT4和TPOAb的变化与临床和亚临床甲状腺功能减退发病率无相关性。
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引用次数: 1
Prediction Models for Type 2 Diabetes Risk in the General Population: A Systematic Review of Observational Studies. 普通人群2型糖尿病风险预测模型:一项观察性研究的系统综述
IF 2.1 Q3 Medicine Pub Date : 2021-03-22 eCollection Date: 2021-07-01 DOI: 10.5812/ijem.109206
Samaneh Asgari, Davood Khalili, Farhad Hosseinpanah, Farzad Hadaegh

Objectives: This study aimed to provide an overview of prediction models of undiagnosed type 2 diabetes mellitus (U-T2DM) or the incident T2DM (I-T2DM) using the transparent reporting of a multivariable prediction model for individual prognosis or diagnosis (TRIPOD) checklist and the prediction model risk of the bias assessment tool (PROBAST).

Data sources: Both PUBMED and EMBASE databases were searched to guarantee adequate and efficient coverage.

Study selection: Articles published between December 2011 and October 2019 were considered.

Data extraction: For each article, information on model development requirements, discrimination measures, calibration, overall performance, clinical usefulness, overfitting, and risk of bias (ROB) was reported.

Results: The median (interquartile range; IQR) number of the 46 study populations for model development was 5711 (1971 - 27426) and 2457 (2060 - 6995) individuals for I-T2DM and U-T2DM, respectively. The most common reported predictors were age and body mass index, and only the Qrisk-2017 study included social factors (e.g., Townsend score). Univariable analysis was reported in 46% of the studies, and the variable selection procedure was not clear in 17.4% of them. Moreover, internal and external validation was reported in 43% the studies, while over 63% of them reported calibration. The median (IQR) of AUC for I-T2DM models was 0.78 (0.74 - 0.82); the corresponding value for studies derived before October 2011 was 0.80 (0.77 - 0.83). The highest discrimination index was reported for Qrisk-2017 with C-statistics of 0.89 for women and 0.87 for men. Low ROB for I-T2DM and U-T2DM was assessed at 18% and 41%, respectively.

Conclusions: Among prediction models, an intermediate to poor quality was reassessed in several aspects of model development and validation. Generally, despite its new risk factors or new methodological aspects, the newly developed model did not increase our capability in screening/predicting T2DM, mainly in the analysis part. It was due to the lack of external validation of the prediction models.

目的:本研究旨在通过透明报告个体预后或诊断的多变量预测模型(TRIPOD)清单和预测模型风险偏倚评估工具(PROBAST),对未确诊的2型糖尿病(U-T2DM)或T2DM (I-T2DM)的预测模型进行概述。数据来源:检索了PUBMED和EMBASE数据库,以确保充分和有效的覆盖。研究选择:纳入2011年12月至2019年10月间发表的文章。数据提取:对于每篇文章,报告了关于模型开发要求、判别措施、校准、总体性能、临床有用性、过拟合和偏倚风险(ROB)的信息。结果:中位数(四分位数间距;46个研究人群中I-T2DM和U-T2DM模型开发的IQR数分别为5711(1971 - 27426)和2457(2060 - 6995)例。最常见的预测因素是年龄和体重指数,只有Qrisk-2017研究纳入了社会因素(例如汤森评分)。46%的研究报告了单变量分析,17.4%的研究报告的变量选择程序不明确。此外,43%的研究报告了内部和外部验证,而超过63%的研究报告了校准。I-T2DM模型AUC的中位数(IQR)为0.78 (0.74 ~ 0.82);2011年10月之前的研究对应值为0.80(0.77 ~ 0.83)。Qrisk-2017的歧视指数最高,女性的c统计值为0.89,男性为0.87。I-T2DM和U-T2DM的低ROB分别为18%和41%。结论:在预测模型中,在模型开发和验证的几个方面重新评估了中等到较差的质量。总的来说,尽管有新的危险因素或新的方法方面,新开发的模型并没有提高我们筛查/预测T2DM的能力,主要是在分析部分。这是由于预测模型缺乏外部验证。
{"title":"Prediction Models for Type 2 Diabetes Risk in the General Population: A Systematic Review of Observational Studies.","authors":"Samaneh Asgari,&nbsp;Davood Khalili,&nbsp;Farhad Hosseinpanah,&nbsp;Farzad Hadaegh","doi":"10.5812/ijem.109206","DOIUrl":"https://doi.org/10.5812/ijem.109206","url":null,"abstract":"<p><strong>Objectives: </strong>This study aimed to provide an overview of prediction models of undiagnosed type 2 diabetes mellitus (U-T2DM) or the incident T2DM (I-T2DM) using the transparent reporting of a multivariable prediction model for individual prognosis or diagnosis (TRIPOD) checklist and the prediction model risk of the bias assessment tool (PROBAST).</p><p><strong>Data sources: </strong>Both PUBMED and EMBASE databases were searched to guarantee adequate and efficient coverage.</p><p><strong>Study selection: </strong>Articles published between December 2011 and October 2019 were considered.</p><p><strong>Data extraction: </strong>For each article, information on model development requirements, discrimination measures, calibration, overall performance, clinical usefulness, overfitting, and risk of bias (ROB) was reported.</p><p><strong>Results: </strong>The median (interquartile range; IQR) number of the 46 study populations for model development was 5711 (1971 - 27426) and 2457 (2060 - 6995) individuals for I-T2DM and U-T2DM, respectively. The most common reported predictors were age and body mass index, and only the Qrisk-2017 study included social factors (e.g., Townsend score). Univariable analysis was reported in 46% of the studies, and the variable selection procedure was not clear in 17.4% of them. Moreover, internal and external validation was reported in 43% the studies, while over 63% of them reported calibration. The median (IQR) of AUC for I-T2DM models was 0.78 (0.74 - 0.82); the corresponding value for studies derived before October 2011 was 0.80 (0.77 - 0.83). The highest discrimination index was reported for Qrisk-2017 with C-statistics of 0.89 for women and 0.87 for men. Low ROB for I-T2DM and U-T2DM was assessed at 18% and 41%, respectively.</p><p><strong>Conclusions: </strong>Among prediction models, an intermediate to poor quality was reassessed in several aspects of model development and validation. Generally, despite its new risk factors or new methodological aspects, the newly developed model did not increase our capability in screening/predicting T2DM, mainly in the analysis part. It was due to the lack of external validation of the prediction models.</p>","PeriodicalId":13969,"journal":{"name":"International Journal of Endocrinology and Metabolism","volume":null,"pages":null},"PeriodicalIF":2.1,"publicationDate":"2021-03-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/65/3b/ijem-19-3-109206.PMC8453657.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"39474825","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}
引用次数: 9
Prevalence of Subclinical Hypothyroidism in Chronic Kidney Disease in a Population-based Study: Tehran Thyroid Study. 一项基于人群的慢性肾病亚临床甲状腺功能减退患病率研究:德黑兰甲状腺研究
IF 2.1 Q3 Medicine Pub Date : 2021-03-17 eCollection Date: 2021-04-01 DOI: 10.5812/ijem.103750
Sara Kazempour-Ardebili, Atefeh Amouzegar, Maryam Tohidi, Atieh Amouzegar, Fereidoun Azizi

Background: Chronic kidney disease (CKD) is a rising public health concern that has detrimental effects on cardiovascular health and overall survival. Subclinical hypothyroidism (SCH) has been associated with poor outcomes in the general population. It is thought to be more prevalent in CKD subjects, and their coexistence may contribute to poor outcomes in these patients. We aimed to determine the prevalence of SCH in CKD.

Methods: Using data from the Tehran thyroid study, which is a prospective population-based cohort study, adult subjects with an estimated Glomerular Filtration Rate (eGFR) of 60 mL/min/1.73 m2 or less were selected for studying the prevalence of thyroid abnormalities, as well as other known cardiovascular risk factors.

Results: Of 5,626 subjects recruited, 823 (14.6%) individuals had CKD. Individuals with CKD were older, heavier, had a higher prevalence of diabetes, higher serum thyrotropin, and thyroid peroxidase anti-body levels, but lower free thyroxine levels. The prevalence of SCH was 7.3% and 5.2% (P < 0.001) in kidney disease and non-kidney disease subjects, respectively. However, there was no difference in the risk of SCH between CKD and non-CKD subjects after adjustment for age, sex, BMI, smoking, and TPOAb (OR: 1.28; 95%CI, 0.89 - 1.83). None of the metabolic markers compared between the CKD subgroups of those with and without SCH remained statistically significantly different after adjusting for age and gender.

Conclusions: The prevalence of SCH was not higher in CKD after controlling for confounding factors. Besides, CKD subjects with and without SCH had no different metabolic parameters.

背景:慢性肾脏疾病(CKD)是一个日益严重的公共卫生问题,对心血管健康和总体生存有不利影响。在一般人群中,亚临床甲状腺功能减退症(SCH)与不良预后相关。它被认为在CKD患者中更为普遍,它们的共存可能导致这些患者预后不良。我们的目的是确定慢性肾病中SCH的患病率。方法:使用来自德黑兰甲状腺研究的数据,这是一项前瞻性人群队列研究,选择肾小球滤过率(eGFR)估计为60 mL/min/1.73 m2或以下的成人受试者,研究甲状腺异常的患病率,以及其他已知的心血管危险因素。结果:在招募的5626名受试者中,823人(14.6%)患有CKD。CKD患者年龄较大,体重较重,糖尿病患病率较高,血清促甲状腺素和甲状腺过氧化物酶抗体水平较高,但游离甲状腺素水平较低。肾脏疾病和非肾脏疾病患者的SCH患病率分别为7.3%和5.2% (P < 0.001)。然而,在调整年龄、性别、BMI、吸烟和TPOAb后,CKD和非CKD受试者之间发生SCH的风险没有差异(OR: 1.28;95%ci, 0.89 - 1.83)。在调整年龄和性别后,有和没有SCH的CKD亚组之间的代谢标志物比较没有统计学意义上的显著差异。结论:在控制了混杂因素后,慢性阻塞性肺病的SCH患病率并不高。此外,有无SCH的CKD受试者的代谢参数没有差异。
{"title":"Prevalence of Subclinical Hypothyroidism in Chronic Kidney Disease in a Population-based Study: Tehran Thyroid Study.","authors":"Sara Kazempour-Ardebili,&nbsp;Atefeh Amouzegar,&nbsp;Maryam Tohidi,&nbsp;Atieh Amouzegar,&nbsp;Fereidoun Azizi","doi":"10.5812/ijem.103750","DOIUrl":"https://doi.org/10.5812/ijem.103750","url":null,"abstract":"<p><strong>Background: </strong>Chronic kidney disease (CKD) is a rising public health concern that has detrimental effects on cardiovascular health and overall survival. Subclinical hypothyroidism (SCH) has been associated with poor outcomes in the general population. It is thought to be more prevalent in CKD subjects, and their coexistence may contribute to poor outcomes in these patients. We aimed to determine the prevalence of SCH in CKD.</p><p><strong>Methods: </strong>Using data from the Tehran thyroid study, which is a prospective population-based cohort study, adult subjects with an estimated Glomerular Filtration Rate (eGFR) of 60 mL/min/1.73 m<sup>2</sup> or less were selected for studying the prevalence of thyroid abnormalities, as well as other known cardiovascular risk factors.</p><p><strong>Results: </strong>Of 5,626 subjects recruited, 823 (14.6%) individuals had CKD. Individuals with CKD were older, heavier, had a higher prevalence of diabetes, higher serum thyrotropin, and thyroid peroxidase anti-body levels, but lower free thyroxine levels. The prevalence of SCH was 7.3% and 5.2% (P < 0.001) in kidney disease and non-kidney disease subjects, respectively. However, there was no difference in the risk of SCH between CKD and non-CKD subjects after adjustment for age, sex, BMI, smoking, and TPOAb (OR: 1.28; 95%CI, 0.89 - 1.83). None of the metabolic markers compared between the CKD subgroups of those with and without SCH remained statistically significantly different after adjusting for age and gender.</p><p><strong>Conclusions: </strong>The prevalence of SCH was not higher in CKD after controlling for confounding factors. Besides, CKD subjects with and without SCH had no different metabolic parameters.</p>","PeriodicalId":13969,"journal":{"name":"International Journal of Endocrinology and Metabolism","volume":null,"pages":null},"PeriodicalIF":2.1,"publicationDate":"2021-03-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/db/cd/ijem-19-2-103750.PMC8198616.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"39249530","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}
引用次数: 1
Clinical and Laboratory Characteristics of a Large Iranian Kindred Afflicted with Von Hippel Lindau Disease. 一个伊朗大亲属患Von Hippel Lindau病的临床和实验室特征
IF 2.1 Q3 Medicine Pub Date : 2021-03-16 eCollection Date: 2021-04-01 DOI: 10.5812/ijem.105189
Ali Asghar Mir Saeid Ghazi, Atieh Amouzegar, Azita Zadeh-Vakili, Abdolreza Sheikh Rezaei, Alireza Amirbaigloo, Marjan Zarif Yeganeh, Hasan Hashemi, Fereidoun Azizi

Background: Von Hippel Lindau (VHL) disease is a hereditary disorder characterized by the development of benign or malignant tumors in the brain, spinal cord, eyes, adrenal medulla, kidney, pancreas, and many other organs. Advances in molecular diagnosis have led to the identification of the affected members of families at earlier stages. We present the clinical, laboratory, and genetic characteristics of five generations of a large Iranian kindred with VHL.

Methods: The proband, a 52-year-old Iranian man, was recognized with VHL. All family members underwent clinical, laboratory, imaging, and genetic evaluation. Medical files and histopathology reports of patients who had been operated on before were also reviewed. Diagnosis of the disease was based on clinical findings, positive family history of VHL, and development of a central nervous system or retinal hemangioblastoma or pheochromocytoma.

Results: Based on diagnostic criteria, our initial evaluations revealed that 10 members of the family had already been affected by the disease. Among them, nine had pheochromocytoma, and one had retinal hemangioblastoma. There was no case of kidney tumors among the kindred.

Conclusions: Study results show the high penetrance of the disease and focus on the large burden imposed by the disease on the health and quality of life of patients afflicted with the disease, emphasizing the importance of surveillance from early childhood for detection and management of the disease as early as possible.

背景:Von Hippel - Lindau (VHL)病是一种遗传性疾病,其特征是在脑、脊髓、眼睛、肾上腺髓质、肾脏、胰腺和许多其他器官中发生良性或恶性肿瘤。分子诊断的进步使我们能够在早期阶段识别出受影响的家庭成员。我们提出临床,实验室和遗传特征的五代大伊朗亲属与VHL。方法:先证者为52岁伊朗男性,确诊为VHL。所有家庭成员都接受了临床、实验室、影像学和遗传评估。对既往手术患者的医疗档案和组织病理学报告也进行了回顾。该疾病的诊断基于临床表现、VHL阳性家族史、中枢神经系统或视网膜血管母细胞瘤或嗜铬细胞瘤的发展。结果:根据诊断标准,我们的初步评估显示,该家庭已有10名成员受到该病的影响。其中嗜铬细胞瘤9例,视网膜血管母细胞瘤1例。本组亲属无肾肿瘤病例。结论:研究结果显示该病的高外显率,并关注该病对患者健康和生活质量造成的巨大负担,强调儿童早期监测对尽早发现和管理该病的重要性。
{"title":"Clinical and Laboratory Characteristics of a Large Iranian Kindred Afflicted with Von Hippel Lindau Disease.","authors":"Ali Asghar Mir Saeid Ghazi,&nbsp;Atieh Amouzegar,&nbsp;Azita Zadeh-Vakili,&nbsp;Abdolreza Sheikh Rezaei,&nbsp;Alireza Amirbaigloo,&nbsp;Marjan Zarif Yeganeh,&nbsp;Hasan Hashemi,&nbsp;Fereidoun Azizi","doi":"10.5812/ijem.105189","DOIUrl":"https://doi.org/10.5812/ijem.105189","url":null,"abstract":"<p><strong>Background: </strong>Von Hippel Lindau (VHL) disease is a hereditary disorder characterized by the development of benign or malignant tumors in the brain, spinal cord, eyes, adrenal medulla, kidney, pancreas, and many other organs. Advances in molecular diagnosis have led to the identification of the affected members of families at earlier stages. We present the clinical, laboratory, and genetic characteristics of five generations of a large Iranian kindred with VHL.</p><p><strong>Methods: </strong>The proband, a 52-year-old Iranian man, was recognized with VHL. All family members underwent clinical, laboratory, imaging, and genetic evaluation. Medical files and histopathology reports of patients who had been operated on before were also reviewed. Diagnosis of the disease was based on clinical findings, positive family history of VHL, and development of a central nervous system or retinal hemangioblastoma or pheochromocytoma.</p><p><strong>Results: </strong>Based on diagnostic criteria, our initial evaluations revealed that 10 members of the family had already been affected by the disease. Among them, nine had pheochromocytoma, and one had retinal hemangioblastoma. There was no case of kidney tumors among the kindred.</p><p><strong>Conclusions: </strong>Study results show the high penetrance of the disease and focus on the large burden imposed by the disease on the health and quality of life of patients afflicted with the disease, emphasizing the importance of surveillance from early childhood for detection and management of the disease as early as possible.</p>","PeriodicalId":13969,"journal":{"name":"International Journal of Endocrinology and Metabolism","volume":null,"pages":null},"PeriodicalIF":2.1,"publicationDate":"2021-03-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/64/53/ijem-19-2-105189.PMC8198607.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"39249531","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}
引用次数: 1
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International Journal of Endocrinology and Metabolism
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