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

Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01172743
• Other study ID #: 0904010340
• Secondary ID: HMC Protocol # 9
• Status: Terminated
• Start date: June 2009
• Est. completion date: July 2020

Study information

• Verified date: July 2020
• Source: Weill Medical College of Cornell University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 450
• Est. completion date: July 2020
• Est. primary completion date: July 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Type 2 Diabetes Mellitus

Locations

Country	Name	City	State
Qatar	Hamad Medical Corporation	Doha

Sponsors (3)

Lead Sponsor	Collaborator
Weill Medical College of Cornell University	Hamad Medical Corporation, Weill Cornell Medical College in Qatar

Country where clinical trial is conducted

Qatar,