Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

(Pakistan Diabetes Prevention Program PDPP)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
International Diabetes Federation
Helsinki University
Information provided by (Responsible Party):
Dr. Asma Ahmed, Aga Khan University
ClinicalTrials.gov Identifier:
NCT01530165
First received: November 21, 2011
Last updated: January 3, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention
Prediabetic State & High Risk Individuals
Behavioral: Life style counseling

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: A Translation Randodomized Trial of Culturally Specific and Cost Effective Life Style Intervention for the Prevention of Type 2 Diabetes in Pakistan

Resource links provided by NLM:


Further study details as provided by Aga Khan University:

Primary Outcome Measures:
  • Incidence of Type 2 Diabetes [ Time Frame: 2 yrs ] [ Designated as safety issue: No ]
    Incidence of type 2 diabetes based on OGTT, diagnosed by WHO criteria at interim and end of an intervention.


Secondary Outcome Measures:
  • Cost effectiveness [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Cost effectiveness by assessing the incremental costs and benefits per case of diabetes prevented and per quality adjusted life year (QALY).

  • Components of Metabolic syndrome [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    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.

  • The impact of city planning on prevalence of obesity and type 2 diabetes [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 20000
Study Start Date: December 2011
Estimated Study Completion Date: October 2015
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   30 Years to 64 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01530165

Locations
Pakistan
The Aga Khan University Hospital
Karachi, Sindh, Pakistan, 74800
Sponsors and Collaborators
Aga Khan University
International Diabetes Federation
Helsinki University
Investigators
Principal Investigator: Asma Ahmed, MRCP(UK) The Aga Khan University Hospital
Principal Investigator: Jaweed Akhter, FRCP The Aga Khan University Hospital
  More Information

No publications provided

Responsible Party: Dr. Asma Ahmed, Principal Investigator, Aga Khan University
ClinicalTrials.gov Identifier: NCT01530165     History of Changes
Other Study ID Numbers: DS10-A5
Study First Received: November 21, 2011
Last Updated: January 3, 2014
Health Authority: Pakistan: Research Ethics Committee

Keywords provided by Aga Khan University:
IFG
IGTT

Additional relevant MeSH terms:
Prediabetic State
Diabetes Mellitus
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on November 20, 2014