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Secular Trends in the Prevalence of Diabetes in India (STRiDE-I)

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ClinicalTrials.gov Identifier: NCT03490136
Recruitment Status : Completed
First Posted : April 6, 2018
Last Update Posted : July 8, 2019
Sponsor:
Information provided by (Responsible Party):
India Diabetes Research Foundation & Dr. A. Ramachandran's Diabetes Hospitals

Study Description
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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.


Condition or disease
Type2 Diabetes PreDiabetes

Study Design
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Study Type : Observational
Actual Enrollment : 9848 participants
Observational Model: Ecologic or Community
Time Perspective: Cross-Sectional
Official Title: Secular TRends in DiabEtes in India
Actual Study Start Date : May 2016
Actual Primary Completion Date : October 2017
Actual Study Completion Date : June 2019

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. Prevalence of type 2 diabetes [ Time Frame: Upto 18 months ]
    Prevalence of type 2 diabetes ,impaired fasting glucose and impaired glucose tolerance in a city, town and peri urban village in Southern India


Secondary Outcome Measures :
  1. Secular trend in diabetes risk factors [ Time Frame: Upto 18 months ]
  2. Prevalence of cardiovascular risk factors [ Time Frame: Upto 18 months ]
  3. Prevalence of dysglycaemia in the young population aged ≤ 40 years [ Time Frame: Upto 18 months ]
  4. Prevalence of age-related hypertension in these regions [ Time Frame: Upto 18 months ]
  5. Changes in physical activity [ Time Frame: Upto 18 months ]
  6. Quality of diabetes care [ Time Frame: Upto 18 months ]
  7. Changes in dietary habits [ Time Frame: Upto 18 months ]

Eligibility Criteria
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Ages Eligible for Study:   20 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Households of selected families of a city, town and peri-urban village
Criteria

Inclusion Criteria:

Willing to participate and provide informed consent form.

Exclusion Criteria:

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

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03490136


Locations
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India
Dr.Ambady Ramachandran
Chennai, Tamil Nadu, India, 600 008
Sponsors and Collaborators
India Diabetes Research Foundation & Dr. A. Ramachandran's Diabetes Hospitals
Investigators
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Principal Investigator: Ambady Ramachandran, PhD DSc President, India Diabetes Research Foundation
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: India Diabetes Research Foundation & Dr. A. Ramachandran's Diabetes Hospitals
ClinicalTrials.gov Identifier: NCT03490136    
Other Study ID Numbers: IDRF-ARH-004
First Posted: April 6, 2018    Key Record Dates
Last Update Posted: July 8, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Diabetes Mellitus
Prediabetic State
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases