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临床试验/CTRI/2024/04/066456
CTRI/2024/04/066456尚未招募不适用

Multi-Omics markers validation in pre-diabetic individuals to find correlations with insulin deficiency.

DBT Wellcome Trust India Alliance1 个研究点 分布在 1 个国家目标入组 250 人开始时间: 2024年5月15日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
250
试验地点
1
主要终点
Relative contributions of insulin resistance and insulin deficiency to type2 diabetes in India

研究概览

简要总结

This is a clinical cohort study to assess disease progression by baseline pathophysiology - insulin resistance and insulin secretion. A total 2000 healthy individuals will be screened through a clinical questionnaire and physical examination to exclude chronic disease/ drug intake. All the individuals will undergo oral glucose tolerance test. individuals with 2 hour glucose more between 140-199 mg/dl will be considered to have prediabetes and those individuals with 2 hour glucose less than 140mg/dl will be considered controls.Total 200 prediabetc and 50 healthy controls will be recruited in year 1.After obtaining written consent form, participant will provide 3 aliquots of 5ml whole blood, one will be used for biochemical fasting assay (fasting C-peptide, glucagon, somatostatin, polypeptide levels, lipids, liver function test, and HOMA IR, HOMA S, HbA1c) and other 2 aliquots will be stored at -80⁰C. Individuals who are matched for age, gender, and BMI will return for clamp study. Hyperglycaemic clamps studies will be conducted on these 250 individuals and will be carefully followed to assess disease progression by baseline pathophysiology (insulin secretion and insulin resistance). In addition, all individuals screened for the study will have oral glucose tolerance (2hr-OGTT) and bio specimens stored for future validation. The hyperglycaemic clamp study will be repeated on the pre-DM and control individuals at the end of 3 years and 5 years to measure the changes in insulin secretion level. Additionally, biomarkeres identified in the islet OMICS study will be validated in the clinical cohort to assess if any of these markers correlate with insulin secretion

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 45.00 Year(s)(—)
性别
All

入选标准

  • Controls: BMI less than 25 kg/m2 2-hour glucose on OGTT ,140 mg/dl Prediabetes: BMI less than 25 kg/m2 2-hour glucose on OGTT ,140-199 mg/dl.

排除标准

  • Individuals below 18 years and above 45 years of age, BMI more than 25 kg/m2, Individuals with chronic diseases and drug intake, pregnant and lactating females patients who have diabetes related-complications or other co-morbidities.

结局指标

主要结局

Relative contributions of insulin resistance and insulin deficiency to type2 diabetes in India

时间窗: 18 months

次要结局

  • correlations between islet biomarker and insulin deficiency(48 months)

研究者

发起方
DBT Wellcome Trust India Alliance
申办方类型
Government funding agency
责任方
Principal Investigator
主要研究者

Mitnala Sasikala

Translational research centre,Asian Healthcare Foundation

研究点 (1)

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