(Pakistan Diabetes Prevention Program PDPP) (PDPP)

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

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.

Study Overview

• Status: Unknown
• Conditions: Prediabetic State & High Risk Individuals
• Intervention / Treatment: Behavioral: Life style counseling

• Study Type: Interventional
• Enrollment (Anticipated): 20000
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Pakistan
  • Sindh
    • Karachi, Sindh, Pakistan, 74800
      • The Aga Khan University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 64 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: Standard; 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; 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: life style intervention arm; 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; 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Aga Khan University
• Collaborators: University of Helsinki; International Diabetes Federation
• Investigators: Principal Investigator: Asma Ahmed, MRCP(UK), The Aga Khan University Hospital; Principal Investigator: Jaweed Akhter, FRCP, The Aga Khan University Hospital

Study record dates

Study Major Dates

• Study Start: December 1, 2011
• Primary Completion (ANTICIPATED): October 1, 2014
• Study Completion (ANTICIPATED): October 1, 2015

Study Registration Dates

• First Submitted: November 21, 2011
• First Submitted That Met QC Criteria: February 7, 2012
• First Posted (ESTIMATE): February 9, 2012

Study Record Updates

• Last Update Posted (ESTIMATE): January 6, 2014
• Last Update Submitted That Met QC Criteria: January 3, 2014
• Last Verified: January 1, 2014

More Information

Terms related to this study

• Keywords: IFG; IGTT
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Prediabetic State
• Other Study ID Numbers: DS10-A5