Skip to main content
OpenTrials
Completed

NCT Number: NCT01530165

(Pakistan Diabetes Prevention Program PDPP)

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Prediabetic State & High Risk Individuals on the Basis of Diabetes Risk Score Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Prediabetic State

Age range

30 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Aga Khan University Hospital

Karachi, Sindh, 3500, Pakistan

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Life style intervention

Behavioral

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

  1. 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

  1. Components of Metabolic syndrome

    Time frame: 2 years

    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. The impact of city planning on prevalence of obesity and type 2 diabetes

    Time frame: 2 years

    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.

Sponsors and collaborators

Lead sponsor

Aga Khan University

Other

Collaborators

  • International Diabetes Federation
  • University of Helsinki

Registry information

Official study title

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

Acronym: PDPP

Important dates

Study start
2011
Primary completion
2017
Study completion
2017
First posted
Feb 9, 2012
Registry last updated
Jul 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.