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(Pakistan Diabetes Prevention Program PDPP) (PDPP)

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ClinicalTrials.gov Identifier: NCT01530165
Recruitment Status : Unknown
Verified January 2014 by Dr. Asma Ahmed, Aga Khan University.
Recruitment status was:  Active, not recruiting
First Posted : February 9, 2012
Last Update Posted : January 6, 2014
Sponsor:
Collaborators:
International Diabetes Federation
University of Helsinki
Information provided by (Responsible Party):
Dr. Asma Ahmed, Aga Khan University

Study Description
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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 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 or disease Intervention/treatment Phase
Prediabetic State & High Risk Individuals Behavioral: Life style counseling Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20000 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : December 2011
Estimated Primary Completion Date : October 2014
Estimated Study Completion Date : October 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prediabetes

Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  1. Cost effectiveness [ Time Frame: 2 years ]
    Cost effectiveness by assessing the incremental costs and benefits per case of diabetes prevented and per quality adjusted life year (QALY).

  2. 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.

  3. 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.


Eligibility Criteria
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Ages Eligible for Study:   30 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01530165


Locations
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Pakistan
The Aga Khan University Hospital
Karachi, Sindh, Pakistan, 74800
Sponsors and Collaborators
Aga Khan University
International Diabetes Federation
University of Helsinki
Investigators
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Principal Investigator: Asma Ahmed, MRCP(UK) The Aga Khan University Hospital
Principal Investigator: Jaweed Akhter, FRCP The Aga Khan University Hospital
More Information
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Responsible Party: Dr. Asma Ahmed, Principal Investigator, Aga Khan University
ClinicalTrials.gov Identifier: NCT01530165    
Other Study ID Numbers: DS10-A5
First Posted: February 9, 2012    Key Record Dates
Last Update Posted: January 6, 2014
Last Verified: January 2014
Keywords provided by Dr. Asma Ahmed, Aga Khan University:
IFG
IGTT
Additional relevant MeSH terms:
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Prediabetic State
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases