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(Pakistan Diabetes Prevention Program PDPP)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
International Diabetes Federation(IDF)
Helsinki University
Information provided by (Responsible Party):
Dr. Asma Ahmed, Aga Khan University
ClinicalTrials.gov Identifier:
NCT01530165
First received: November 21, 2011
Last updated: February 7, 2012
Last verified: February 2012
History of Changes

November 21, 2011
February 7, 2012
December 2011
August 2012   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01530165 on ClinicalTrials.gov Archive Site
  • 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.
Same as current
Not Provided
Not Provided
 
(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

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.
Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Prediabetic State
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
  • No Intervention: Standard
    Pre diabetics randomized to control arm will receive standard life style advice which is given to all pre diabetics seeking medical advice.
    Intervention: Behavioral: Life style counseling
  • 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.
    Intervention: Behavioral: Life style counseling
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
20000
October 2014
August 2012   (final data collection date for primary outcome measure)

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
Both
30 Years to 64 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Pakistan
 
NCT01530165
DS10-A5
Yes
Dr. Asma Ahmed, Aga Khan University
Aga Khan University
  • International Diabetes Federation(IDF)
  • Helsinki University
Principal Investigator: Asma Ahmed, MRCP(UK) The Aga Khan University Hospital
Principal Investigator: Jaweed Akhter, FRCP The Aga Khan University Hospital
Aga Khan University
February 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP