Collection of Blood for Gene Expression/Genomic Studies in Individuals With Diabetes (Qatar)

This protocol is designed to gather a small amount of blood for extraction of DNA for the study of the genetic basis of diabetes. The study population will include individuals with known diabetes, and controls without diabetes. Investigators aim to understand the genetics of diabetes, and will use the cells and serum from this blood to perform genotyping and gene expression studies of individuals with diabetes and relevant controls.

Study Overview

• Status: Terminated
• Conditions: Diabetes Mellitus; Type 2 Diabetes Mellitus

Detailed Description

This protocol is designed to collect a small amount of blood for extraction of DNA (genetic material) for the study of the genetic basis of diabetes. The study population will include individuals with known diabetes and controls without diabetes. Additionally, this protocol will recruit individuals from the following locations: the Qatar Diabetes Association, the governmental ministries of Qatar, and subjects who have participated in Dr. Bener's HMC protocol #231 entitled "A preliminary study of genetic pre-disposition to diabetic mellitus in the state of Qatar." Individuals with diabetes may also be recruited from the Hamad Hospital outpatient adult diabetes clinics (there are eight diabetes clinics each week) and/or from the population of subjects who previously participated in Dr. Mushlin's IRB approved protocol #0608008703 entitled "Comparing the Clinical Management and Genetic Markers of Diabetes in Qatar to International Standards" at Hamad Medical Corporation or IRB approved protocol #0602008388 entitled "The Impact of Cardiac and Genetic Risk Factors on Acute Myocardial Infarction and Cerebrovascular Stroke in Qatar: A Case-Control Study". In this protocol, researchers will survey medical records of patients with diabetes, in order to study the clinical characteristics of these individuals, and the researchers will collect blood to evaluate the genetic characteristics of individuals with diabetes. The researchers will also collect blood samples of individuals without diabetes to serve as control.

• Study Type: Observational
• Enrollment (Actual): 450

Contacts and Locations

Study Locations

• Qatar
  • Doha, Qatar
    • Hamad Medical Corporation

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Diabetes group will be taken from (1)individuals visiting the Medicine Department at the Hamad Medical Corporation(HMC), Qatar for standard clinical care, (2)outpatient adult individuals seen at the HMCdiabetes clinics, (3)individuals who have participated in the following IRB protocol #s:0608008703, #0602008388 and HMC protocol #231, (4)ndividuals who attend clinics at the Qatar Diabetes Association (QDA), and (5)Individuals who work at the governmental ministries of Qatar. Controls will be obtained from volunteers without a history of diabetes. Family members of patients may be asked to participate in the study.

Description

Diabetes group

Inclusion criteria:

• Must provide informed consent
• Males and females, age 18 years and older
• Documented evidence of diabetes using at least one of the following: (1) blood tests consistent with Type-II diabetes; (2) oral glucose tolerance tests consistent with Type-II diabetes; (3) subject taking medication to treat Type-II diabetes.

Exclusion criteria:

• Individual refuses consent
• Pregnant females with gestational diabetes
• Type-I diabetes

Normal control group

Inclusion Criteria:

• Must provide informed consent
• Males or females ages 18 years and older
• Resolved gestational diabetes

Exclusion Criteria:

• Individual refuses consent.
• Individuals with history of diabetes.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Diabetes; Individuals with diabetes that fit eligibility criteria.
Normal Control; Individuals without history of diabetes.

Collaborators and Investigators

• Sponsor: Weill Medical College of Cornell University
• Collaborators: Hamad Medical Corporation; Weill Cornell Medical College in Qatar
• Investigators: Study Director: Ronald G Crystal, MD, Weill Cornell Medical College, NY and Qatar

Study record dates

Study Major Dates

• Study Start: June 1, 2009
• Primary Completion (Actual): July 1, 2020
• Study Completion (Actual): July 1, 2020

Study Registration Dates

• First Submitted: July 28, 2010
• First Submitted That Met QC Criteria: July 28, 2010
• First Posted (Estimate): July 30, 2010

Study Record Updates

• Last Update Posted (Actual): July 31, 2020
• Last Update Submitted That Met QC Criteria: July 29, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Keywords: Diabetes; Diabetes Mellitus; Type-2; Adult Onset
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: 0904010340; HMC Protocol # 9093/09 (Other Identifier: Hamad Medical Corporation)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED