NCT01530165

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,564

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2011

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 21, 2011

Completed
24 days until next milestone

Study Start

First participant enrolled

December 15, 2011

Completed
2 months until next milestone

First Posted

Study publicly available on registry

February 9, 2012

Completed
5.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2017

Completed
Last Updated

July 29, 2024

Status Verified

July 1, 2024

Enrollment Period

5.5 years

First QC Date

November 21, 2011

Last Update Submit

July 26, 2024

Conditions

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

Keywords

IFGIGTT

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Components of Metabolic syndrome

    2 years

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

    2 years

Study Arms (2)

Standard

NO INTERVENTION

Pre diabetics randomized to control arm will receive standard life style advice which is given to all pre diabetics seeking medical advice. Group counselling (30 min to 1 hour) will be provided to participants enrolled in control arm in which they will attend one group class at baseline where they will be given basic information on diabetes prevention , weight loss, diet, and exercise consitent with expert recommendations for a healthy life style inclusing losing 5-10% of their excess body weight to reduce their calorie and fat intake and exercising at least 150 minutes per week.

life style intervention arm

OTHER

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. Consists of 5 sessions during the two years course of follow up. Three sessions in the first year (intensive phase), two sessions (maintenance phase) in second year. Overall sessions have a theme with simple selected theoretical background information. Sessions are to be interactive. Selected handouts and pamphlets are given after the session. Teaching material is both available in English and Urdu (local) language.

Behavioral: Life style intervention

Interventions

Life style interventionBEHAVIORAL

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

life style intervention arm

Eligibility Criteria

Age30 Years - 64 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Adult men and women between 30-64 years of age

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Aga Khan University Hospital

Karachi, Sindh, 3500, Pakistan

Location

MeSH Terms

Conditions

Prediabetic State

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Asma Ahmed, MRCP(UK)

    The Aga Khan University Hospital

    PRINCIPAL INVESTIGATOR

  • Jaweed Akhter, FRCP

    The Aga Khan University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Model Details: Intervention versus Control
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

November 21, 2011

First Posted

February 9, 2012

Study Start

December 15, 2011

Primary Completion

June 30, 2017

Study Completion

June 30, 2017

Last Updated

July 29, 2024

Record last verified: 2024-07

Locations

PA(1)