Overview

This trial is active, not recruiting.

Condition prediabetic state & high risk individuals
Treatment life style counseling
Sponsor Aga Khan University
Collaborator International Diabetes Federation
Start date December 2011
End date October 2014
Trial size 20000 participants
Trial identifier NCT01530165, DS10-A5

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 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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose prevention
Arm
(Other)
Pre diabetics randomized to control arm will receive standard life style advice which is given to all pre diabetics seeking medical advice.
life style counseling
The main goals of intervention will focus mainly on: Weight reduction ≥ 5% , moderate intensity physical activity ≥ 30 min daily, dietary fat <30 proportion of total energy, saturated fat <10%, Fiber ≥ 15g/1,000 kcal There will be 9 sessions during the two years course of follow-up
(Experimental)
This arm would be given aggressive life style intervention in comparison to standard (control) arm. The intervention would consist of nutritional and physical activity advice.
life style counseling
The main goals of intervention will focus mainly on: Weight reduction ≥ 5% , moderate intensity physical activity ≥ 30 min daily, dietary fat <30 proportion of total energy, saturated fat <10%, Fiber ≥ 15g/1,000 kcal There will be 9 sessions during the two years course of follow-up

Primary Outcomes

Measure
Incidence of Type 2 Diabetes
time frame: 2 yrs

Secondary Outcomes

Measure
Cost effectiveness
time frame: 2 years
Components of Metabolic syndrome
time frame: 2 years
The impact of city planning on prevalence of obesity and type 2 diabetes
time frame: 2 years

Eligibility Criteria

Male or female participants from 30 years up to 64 years old.

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

Additional Information

Official title A Translation Randodomized Trial of Culturally Specific and Cost Effective Life Style Intervention for the Prevention of Type 2 Diabetes in Pakistan
Principal investigator Asma Ahmed, MRCP(UK)
Trial information was received from ClinicalTrials.gov and was last updated in January 2014.
Information provided to ClinicalTrials.gov by Aga Khan University.