PreDiabetes Clinical Trial
— KADEMOfficial title:
Kuwait Adult Diabetes Epidemiological Multidisciplinary (KADEM) Program
Kuwait and the Gulf Region lack large longitudinal studies that identify risk factors dictating the onset of prediabetes and the progression to diabetes. The Kuwait Diabetes Epidemiology Program (KDEP), previously carried out at Dasman Diabetes Institute, was designed to develop a research dataset providing a random sampling of the Kuwaiti population. The dataset contained primarily epidemiology data for healthy, prediabetic and diabetic individuals; and was designed to serve as a resource for research and prevention programs on obesity, diabetes, and metabolic syndrome. The KDEP data supported research studies at DDI to delineate risk factors for metabolic disease from the views of genetics, biochemistry, immunology and epidemiology. One of the main limitations of the KDEP study was that it only captured a cross-sectional view of the participants in terms of diabetes status as well as lack of extensive phenotyping. In the current study, the investigators aim to perform a follow up on the non-diabetic KDEP cohort participants to enrich it with detailed physiological, genetic, biochemical and environmental data and thereby to establish an association between the development of diabetes and multidimensional risk factors. the investigatorswill also recruit family members of the KDEP and RA2010-005 participants as well as others with family history of diabetes to better identify familial patterns in risk factors. The outcome of this effort will immediately serve as a scientific baseline for developing prevention strategies for the control and management of obesity, diabetes and associated complications such as cardiovascular disease. Given the magnitude of the social and economic burden of diabetes on the Kuwaiti population, longitudinal data from the KDEP Follow-up study should play an important role in establishing the incidence of T2D progression in non-diabetic participants that were enrolled in the initial study as well as of progression to diabetes complications. This will have a positive impact on the population by providing clinicians with data to better target their patient management and by supporting policy and decision-makers in developing comprehensive health promotion programs to control these diseases at the national level.
Status | Recruiting |
Enrollment | 2000 |
Est. completion date | May 23, 2027 |
Est. primary completion date | May 23, 2027 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 21 Years to 75 Years |
Eligibility | Inclusion Criteria: People who participated in the original KDEP study. People with prediabetes. Type 2 Diabetes patients. Exclusion Criteria: People are unwilling to sign the consent form. Pregnant women. |
Country | Name | City | State |
---|---|---|---|
Kuwait | Dasman Diabetes Institute | Kuwait City |
Lead Sponsor | Collaborator |
---|---|
Dasman Diabetes Institute |
Kuwait,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Conversion to Diabetes | The investigators will monitor using HbA1C and FPG or 2-hr plasma glucose to diagnose new cases of diabetes in the original cohort. Type 2 Diabetes will be diagnosed according to ADA criteria. | 5 years | |
Primary | Conversion to Pre-Diabetes | The investigators will monitor using HbA1C and FPG or 2-hr plasma glucose the conversion from normoglycemia to prediabetes in the original cohort. Pre-diabetes will be diagnosed according to ADA criteria. | 5 years |
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