跳至主要内容
临床试验/CTRI/2025/03/083731
CTRI/2025/03/083731尚未招募不适用

Molecular mechanisms in T2D, prediabetes phenotypes and vascular disease in South Asians

Novo Nordisk Foundation3 个研究点 分布在 1 个国家目标入组 11,136 人开始时间: 2025年5月1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
11,136
试验地点
3
主要终点
The primary outcome will be the identification of genetic variants associated with glycemic traits and development of polygenic prediction models for drug response traits for type 2 diabetes.

研究概览

简要总结

This project is based on banked biospecimens (by adding whole genome sequencing (WGS) measurements) and annually collected data from the ongoing NIH-funded cohort study, Precision-CARRS (P-CARRS; P01HL154996; 1R01AG089759). P-CARRS is a representative population-based longitudinal study (initiated in 2010) of socio-demographically diverse adults aged 20 and older living in Delhi and Chennai, India (total=21,864; biospecimens banked for n: 19,278)). P-CARRS has an available and ongoing collection of sociodemographic, behavioral (objectively measured activity, sleep, and stress), environmental (pollutants at street-geocode level), cardiometabolic phenotyping data (risk factors, and imaging of vessels and retina, myocardium, and related organs), and multimodal cognitive (neuropsychological examination, neuroimaging, and blood biomarkers).

There is no new recruitment of participants. We are only using the stored biospecimens from P-CARRS cohort in India for DNA isolation and whole genome sequencing.

研究设计

研究类型
Observational

入排标准

年龄范围
20.00 Year(s) 至 80.00 Year(s)(—)
性别
All

入选标准

  • Group 1: Normal Glucose Tolerant individuals (NGT; n=6793) Individuals with fasting plasma glucose less than 100mg/dl and 2h-PG less than 140mg/dl or HbA1c less than or equal to 5.7% and on no antidiabetic medication.
  • Group 2: Individuals with prediabetes (n=1782) Fasting plasma glucose between 100-125 mg/dL or 2h-PG between 140-199 mg/dL or HbA1c gretaer than 5.7-6.4% and on no antidiabetic medication.
  • Group 3: Individuals with type 2 diabetes (T2D; n=2561) Diagnosis of T2D is based on the ADA criteria.
  • Fasting plasma glucose greater than or equal to 126mg/dl or 2h-PG greater than or equal to200mg/dl or HbA1c greater than 6.4%.

排除标准

  • Participants with type 1 diabetes will be excluded.

结局指标

主要结局

The primary outcome will be the identification of genetic variants associated with glycemic traits and development of polygenic prediction models for drug response traits for type 2 diabetes.

时间窗: At Baseline

次要结局

未报告次要终点

研究者

发起方
Novo Nordisk Foundation
申办方类型
Other [Danish enterprise foundation that supports scientific, humanitarian and social causes]
责任方
Principal Investigator
主要研究者

Dr V Mohan

Madras Diabetes Research Foundation

研究点 (3)

Loading locations...

相似试验