Clinical trial NCT01172743: Collection of Blood for Gene Expression/Genomic Studies in Individuals With Diabetes (Qatar)
Official title: Collection of Blood for Gene Expression/Genomic Studies in Individuals With Diabetes (Qatar)
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Diabetes Mellitus
Type 2 Diabetes Mellitus
Keywords: Diabetes Mellitus
Diabetes
Type-2
Adult Onset
Lead sponsor: Weill Medical College of Cornell University
Sponsor class: OTHER
Collaborators: name: Weill Cornell Medical College in Qatar
name: Hamad Medical Corporation
First posted: 2010-07-30
Enrollment: 450
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Doha
country: Qatar
facility: Hamad Medical Corporation
Study officials:
affiliation: Weill Cornell Medical College, NY and Qatar
name: Ronald G Crystal, MD
role: STUDY_DIRECTOR
References: