Prediabetic State & High Risk Individuals Clinical Trial
— PDPPOfficial title:
A Translation Randodomized Trial of Culturally Specific and Cost Effective Life Style Intervention for the Prevention of Type 2 Diabetes in Pakistan
| Verified date | January 2014 |
| Source | Aga Khan University |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Pakistan: Research Ethics Committee |
| Study type | Interventional |
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.
| Status | Active, not recruiting |
| Enrollment | 20000 |
| Est. completion date | October 2015 |
| Est. primary completion date | October 2014 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Both |
| Age group | 30 Years to 64 Years |
| Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
| Country | Name | City | State |
|---|---|---|---|
| Pakistan | The Aga Khan University Hospital | Karachi | Sindh |
| Lead Sponsor | Collaborator |
|---|---|
| Aga Khan University | Helsinki University, International Diabetes Federation |
Pakistan,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | No |
| Secondary | Cost effectiveness | Cost effectiveness by assessing the incremental costs and benefits per case of diabetes prevented and per quality adjusted life year (QALY). | 2 years | No |
| Secondary | Components of Metabolic syndrome | 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. | 2 years | No |
| Secondary | The impact of city planning on prevalence of obesity and type 2 diabetes | 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. | 2 years | No |