Secular Trends in the Prevalence of Diabetes in India

PreDiabetes Clinical Trial

— STRiDE-I  

Official title:

Secular TRends in DiabEtes in India

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03490136
• Other study ID #: IDRF-ARH-004
• Status: Completed
• Start date: May 2016
• Est. completion date: June 2019

Study information

• Verified date: July 2019
• Source: India Diabetes Research Foundation & Dr. A. Ramachandran's Diabetes Hospitals
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Series of epidemiological studies have been carried out by the research team since 1988 studying the changes in the prevalence of type 2 diabetes, prediabetes and associated risk factors. These studies have shown that the determinants to rising prevalence of diabetes vary among populations and with time. Comparative studies from the same region can help to understand the secular changes occurring in a specific population. In this proposal we intend to conduct a cross-sectional survey with varied levels of urbanisation and compare the findings with our earlier reported data to assess the degree of changes in dysglycaemic prevalences. The primary aim of the proposal is to study the secular changes and the prevalence of diabetes, prediabetes and associated cardio-metabolic risk factors with varying levels of urbanization.

A multi-stage random selection method will be used. Field workers will conduct an enumeration of the individuals above 20 years of age. In each location, streets will be randomly selected to have an equal representativeness from different socio-economic strata. All eligible family members of the selected households are invited for the survey. The study outcomes will be of relevance in public health research in modeling effective national healthcare policies.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9848
• Est. completion date: June 2019
• Est. primary completion date: October 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 70 Years

Eligibility

Inclusion Criteria:

Willing to participate and provide informed consent form.

Exclusion Criteria:

Age less than 20 years,cognitive impairment, unwilling to participate

Related Conditions & MeSH terms

• Diabetes Mellitus
• PreDiabetes
• Prediabetic State
• Type2 Diabetes

Locations

Country	Name	City	State
India	Dr.Ambady Ramachandran	Chennai	Tamil Nadu

Sponsors (1)

Lead Sponsor	Collaborator
India Diabetes Research Foundation & Dr. A. Ramachandran's Diabetes Hospitals

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prevalence of type 2 diabetes	Prevalence of type 2 diabetes ,impaired fasting glucose and impaired glucose tolerance in a city, town and peri urban village in Southern India	Upto 18 months
Secondary	Secular trend in diabetes risk factors		Upto 18 months
Secondary	Prevalence of cardiovascular risk factors		Upto 18 months
Secondary	Prevalence of dysglycaemia in the young population aged = 40 years		Upto 18 months
Secondary	Prevalence of age-related hypertension in these regions		Upto 18 months
Secondary	Changes in physical activity		Upto 18 months
Secondary	Quality of diabetes care		Upto 18 months
Secondary	Changes in dietary habits		Upto 18 months