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Type2 DiabetesSTRiDE-INCT03490136

Secular Trends in the Prevalence of Diabetes in India

An observational study of Type2 Diabetes and PreDiabetes, run by India Diabetes Research Foundation & Dr. A. Ramachandran's Diabetes Hospitals at 1 site in India.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 20 to 70 yearsHealthy volunteers can take part
Conditions the study is for
Type2 Diabetes, PreDiabetes
How many people
9,848 participants
Where
1 siteIndia
Study dates
May 2016to Jun 2019
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 70 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

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

Who may be able to join

  • Willing to participate and provide informed consent form.

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

India1 site

  • Dr.Ambady Ramachandran

    Chennai, Tamil Nadu, 600 008

Other trials in India

About this study

Official title: Secular TRends in DiabEtes in India

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.

Medical subject headings
Prediabetic State

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: Upto 18 months

Secondary outcomes (7)

  1. Secular trend in diabetes risk factors

    Measured: Upto 18 months

  2. Prevalence of cardiovascular risk factors

    Measured: Upto 18 months

  3. Prevalence of dysglycaemia in the young population aged ≤ 40 years

    Measured: Upto 18 months

  4. Prevalence of age-related hypertension in these regions

    Measured: Upto 18 months

  5. Changes in physical activity

    Measured: Upto 18 months

  6. Quality of diabetes care

    Measured: Upto 18 months

  7. Changes in dietary habits

    Measured: Upto 18 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Apr 2018
  2. Study startMay 2016
  3. Primary completionOct 2017
  4. Study completionJun 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Ecologic or community
Time perspective
Cross-sectional
Enrolment
9,848 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03490136
Sponsor's protocol ID
IDRF-ARH-004
Acronym
STRiDE-I
Status last verified
Jul 2019
First submitted
7 Mar 2018
Last updated
8 Jul 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 38923743

  • 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.

    PubMed 30659076

Questions about this trial

What is this clinical trial studying?

An observational study of Type2 Diabetes and PreDiabetes, run by India Diabetes Research Foundation & Dr. A. Ramachandran's Diabetes Hospitals at 1 site in India.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Prevalence of type 2 diabetes (time frame: Upto 18 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03490136, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2019.

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