(Pakistan Diabetes Prevention Program PDPP)

Study Overview
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Brief Summary
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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.

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

Conditions
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Prediabetic State & High Risk Individuals

Intervention / Treatment
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* Behavioral: Life style counseling


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Standard<br>Pre diabetics randomized to control arm will receive standard life style advice which is given to all pre diabetics seeking medical advice. | Behavioral: Life style counseling<br>* 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<br>|
| Experimental: life style intervention arm<br>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. | Behavioral: Life style counseling<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Type 2 Diabetes | Incidence of type 2 diabetes based on OGTT, diagnosed by WHO criteria at interim and end of an intervention. | 2 yrs | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cost effectiveness | Cost effectiveness by assessing the incremental costs and benefits per case of diabetes prevented and per quality adjusted life year (QALY). | 2 years | 
| Components of Metabolic syndrome | To assess the difference in incidence of components of metabolic syndrom which includes waist circumference, dyslipidimia, blood pressure etc between control and intervention arm after 2 years of lifestyle intervention. | 2 years | 
| The impact of city planning on prevalence of obesity and type 2 diabetes | The communities will be divided according to number and accessibility of parks. The community with large number of parks will be compared with community with no parks and then change in incidence of diabetes and obesity after 2 years of lifestyle intervention will be assessed and compared between two communities. By this it would be feasible to convince local authorities to incorporate this into their agenda for future urban design. | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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IFG, IGTT