NCT03490136

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
9,848

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2016

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2016

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2017

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

March 7, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 6, 2018

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2019

Completed
Last Updated

July 8, 2019

Status Verified

July 1, 2019

Enrollment Period

1.4 years

First QC Date

March 7, 2018

Last Update Submit

July 5, 2019

Conditions

Type2 DiabetesPreDiabetes

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (7)

  • Secular trend in diabetes risk factors

    Upto 18 months

  • Prevalence of cardiovascular risk factors

    Upto 18 months

  • Prevalence of dysglycaemia in the young population aged ≤ 40 years

    Upto 18 months

  • Prevalence of age-related hypertension in these regions

    Upto 18 months

  • Changes in physical activity

    Upto 18 months

  • +2 more secondary outcomes

Eligibility Criteria

Age20 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Households of selected families of a city, town and peri-urban village

You may qualify if:

  • Willing to participate and provide informed consent form.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dr.Ambady Ramachandran

Chennai, Tamil Nadu, 600 008, India

Location

Related Publications (2)

  • Nanditha A, Susairaj P, Satheesh K, Raghavan A, Snehalatha C, Ramachandran A. The rising prevalence of type 2 diabetes among the youth in southern India-An ancillary analysis of the Secular TRends in DiabEtes in India (STRiDE-I) study. J Diabetes. 2024 Jul;16(7):e13576. doi: 10.1111/1753-0407.13576.

    PMID: 38923743DERIVED

  • 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.

    PMID: 30659076DERIVED

MeSH Terms

Conditions

Prediabetic State

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Ambady Ramachandran, PhD DSc

    President, India Diabetes Research Foundation

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 7, 2018

First Posted

April 6, 2018

Study Start

May 1, 2016

Primary Completion

October 1, 2017

Study Completion

June 1, 2019

Last Updated

July 8, 2019

Record last verified: 2019-07

Data Sharing

IPD Sharing
Will not share

Locations

IN(1)