Clinical trial NCT03490136: Secular Trends in the Prevalence of Diabetes in India
Official title: Secular TRends in DiabEtes in India
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Type2 Diabetes
PreDiabetes
Lead sponsor: India Diabetes Research Foundation & Dr. A. Ramachandran's Diabetes Hospitals
Sponsor class: OTHER
First posted: 2018-04-06
Enrollment: 9848
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Households of selected families of a city, town and peri-urban village

Brief 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.


Eligibility criteria: Inclusion Criteria:

Willing to participate and provide informed consent form.

Exclusion Criteria:

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

Primary outcomes:
measure: Prevalence of type 2 diabetes
timeFrame: Upto 18 months
Secondary outcomes:
measure: Secular trend in diabetes risk factors
timeFrame: Upto 18 months
measure: Prevalence of cardiovascular risk factors
timeFrame: Upto 18 months
measure: Prevalence of dysglycaemia in the young population aged ≤ 40 years
timeFrame: Upto 18 months
measure: Prevalence of age-related hypertension in these regions
timeFrame: Upto 18 months
measure: Changes in physical activity
timeFrame: Upto 18 months
measure: Quality of diabetes care
timeFrame: Upto 18 months
measure: Changes in dietary habits
timeFrame: Upto 18 months
Other outcomes:
Locations:
city: Chennai
country: India
facility: Dr.Ambady Ramachandran
state: Tamil Nadu
Study officials:
affiliation: President, India Diabetes Research Foundation
name: Ambady Ramachandran, PhD DSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: Nanditha A, Snehalatha C, Satheesh K, Susairaj P, Simon M, Vijaya L, Raghavan A, Vinitha R, Ramachandran A. Secular TRends in DiabEtes in India (STRiDE-I): Change in Prevalence in 10 Years Among Urban and Rural Populations in Tamil Nadu. Diabetes Care. 2019 Mar;42(3):476-485. doi: 10.2337/dc18-1559. Epub 2019 Jan 18.