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Clinical Trials/CTRI/2024/04/066456
CTRI/2024/04/066456Not yet recruitingNot Applicable

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

DBT Wellcome Trust India Alliance1 site in 1 country250 target enrollmentStarted: May 15, 2024Last updated:

Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Sponsor
Enrollment
250
Locations
1
Primary Endpoint
Relative contributions of insulin resistance and insulin deficiency to type2 diabetes in India

Study Overview

Brief Summary

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

Study Design

Study Type
Observational

Eligibility Criteria

Ages
18.00 Year(s) to 45.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • 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.

Exclusion Criteria

  • 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.

Outcomes

Primary Outcomes

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

Time Frame: 18 months

Secondary Outcomes

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

Investigators

Sponsor
DBT Wellcome Trust India Alliance
Sponsor Class
Government funding agency
Responsible Party
Principal Investigator
Principal Investigator

Mitnala Sasikala

Translational research centre,Asian Healthcare Foundation

Study Sites (1)

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