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(Pakistan Diabetes Prevention Program PDPP)

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01530165
Acronym
PDPP
Enrollment
1564
Registered
2012-02-09
Start date
2011-12-15
Completion date
2017-06-30
Last updated
2024-07-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prediabetic State & High Risk Individuals on the Basis of Diabetes Risk Score

Keywords

IFG, IGTT

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.

Interventions

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

Sponsors

International Diabetes Federation
CollaboratorOTHER
University of Helsinki
CollaboratorOTHER
Aga Khan University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE

Intervention model description

Intervention versus Control

Eligibility

Sex/Gender
ALL
Age
30 Years to 64 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Incidence of Type 2 Diabetes2 yrsIncidence of type 2 diabetes based on OGTT, diagnosed by WHO criteria at interim and end of an intervention.

Secondary

MeasureTime frameDescription
Components of Metabolic syndrome2 yearsTo 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.
The impact of city planning on prevalence of obesity and type 2 diabetes2 yearsThe 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.

Countries

Pakistan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026