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Clinical Trials/NCT01530165
NCT01530165
Completed
Not Applicable

A Translation Randodomized Trial of Culturally Specific and Cost Effective Life Style Intervention for the Prevention of Type 2 Diabetes in Pakistan

Aga Khan University1 site in 1 country1,564 target enrollmentDecember 15, 2011

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Prediabetic State & High Risk Individuals on the Basis of Diabetes Risk Score
Sponsor
Aga Khan University
Enrollment
1564
Locations
1
Primary Endpoint
Incidence of Type 2 Diabetes
Status
Completed
Last Updated
last year

Overview

Brief Summary

The Karachi-based Pakistan Diabetes Prevention Study aims to address key issues in the prevention of type 2 diabetes. Approximately 20,000 people From four communities will be screened for diabetes risk factors using a non-invasive diabetes risk-score system. Those found to be at increased risk will be given an oral glucose tolerance test. People who, after the oral glucose tolerance test, are identified as having prediabetes or normal but with risk factors such as raised BMI and/or history of hypertension will have the opportunity to take part in the Pakistan Diabetes Prevention Study lifestyle intervention. This consists of culturally adjusted preventive strategies focusing on diet and physical activity in real-life settings. Another important aspect of this trial will be to assess the impact of urban planning on the prevalence of obesity and diabetes.

Detailed Description

The aim of this study is to translate the life style intervention project to prevent diabetes into real life settings in Karachi, Pakistan, home to one sixth of the world's population.

Registry
clinicaltrials.gov
Start Date
December 15, 2011
End Date
June 30, 2017
Last Updated
last year
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Dr. Asma Ahmed

Assistant Professor

Aga Khan University

Eligibility Criteria

Inclusion Criteria

  • Adult men and women between 30-64 years of age

Exclusion Criteria

  • Diagnosed type 1 or type 2 diabetes
  • Pregnancy or presence of chronic disease rendering survival for three years unlikely
  • Any psychological or physical disability to interfere with participation in the study
  • Ischemic heart disease

Outcomes

Primary Outcomes

Incidence of Type 2 Diabetes

Time Frame: 2 yrs

Incidence of type 2 diabetes based on OGTT, diagnosed by WHO criteria at interim and end of an intervention.

Secondary Outcomes

  • Components of Metabolic syndrome(2 years)
  • The impact of city planning on prevalence of obesity and type 2 diabetes(2 years)

Study Sites (1)

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