Kuwait Adult Diabetes Epidemiological Multidisciplinary (KADEM) Program

NCT06115876 | Recruiting

• 1 other identifier: RAHM2019-030
• Study Type: observational
• Target: 2,000
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Diabetes Mellitus Type 2, Diabetes Mellitus Type 1; NAFLD - Nonalcoholic Fatty Liver Disease; PreDiabetes

Keywords

Prediabetes; Kuwait; KFAS; Dasman Diabetes Institute; Diabetes Prevention; NAFLD

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (2)

Pre-Diabetes

Fasting Blood glucose ≥ and \<7 5.6mmol/L ≥100 and\<126 mg/dL HbA1C 5.7% to 6.4% 2hr Oral Glucose Tolerance Test (OGTT) ≥7.8 and \<11.1 mmol/L ≥140 and\<200 mg/dL

Diabetes

Fasting Blood glucose 7 mmol/L (126mg/dL) or higher HbA1C 6.5% or higher 2hr Oral Glucose Tolerance Test (OGTT) 11.1 mmol/L (200 mg/dL) or higher

Eligibility Criteria

• Age: 21 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The study will be performed in several phases. At the first phase we will recall subjects with prediabetes (n=1787), because we anticipate that many of whom have converted to T2DM. Other high risk individuals will be also enrolled in study for OGTT assessment. Additionally, subjects who are already diagnosed with diabetes (T1DM and / or T2DM) and/or receive antidiabetic therapy \& participants between age of 10 and 21 years will not receive an OGTT. They only will receive a single blood draw (at baseline), and complete the questionnaire and all other imaging measurements described above.

You may qualify if:

• People who participated in the original KDEP study. People with prediabetes. Type 2 Diabetes patients.

You may not qualify if:

• People are unwilling to sign the consent form. Pregnant women.

Sponsors & Collaborators

• Dasman Diabetes Institute: lead

Study Sites (1)

Dasman Diabetes Institute

Kuwait City, 40000, Kuwait

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Plasma, Serum, PBMC, DNA,

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Diabetes Mellitus, Type 1; Non-alcoholic Fatty Liver Disease; Prediabetic State

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases; Fatty Liver; Liver Diseases; Digestive System Diseases

Central Study Contacts

Mohamed Abu-farha, PhD

CONTACT

+96560660804; mohamed.abufarha@dasmaninstitute.org

Fahd Al-Mulla, MD, PhD

CONTACT

2224 2999; fahd.almulla@dasmaninstitute.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 16, 2023
• First Posted: November 3, 2023
• Study Start: May 23, 2022
• Primary Completion (Estimated): May 23, 2027
• Study Completion (Estimated): May 23, 2027
• Last Updated: November 3, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: mid-2024 till 2027

Locations

KU (1)