Collection of Blood for Gene Expression/Genomic Studies in Individuals With Diabetes (Qatar)
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Purpose
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.
| Condition |
|---|
|
Diabetes Mellitus Type 2 Diabetes Mellitus |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Collection of Blood for Gene Expression/Genomic Studies in Individuals With Diabetes (Qatar) |
Genomic DNA will be extracted, and genome wide SNP analysis and promoter sequences for genes will be obtained. The goal is to find single nucleotide polymorphims (SNP), small changes in single genes that affect disease risk, to see if they correlate with diabetes. Serum will be stored for future studies, for a period of 6 years, to look at levels of proteins. Subjects who consent to participate in this study will have their serum stored for up to 6 years, inorder to be used for future studies on genomics.
| Estimated Enrollment: | 500 |
| Study Start Date: | June 2009 |
| Estimated Study Completion Date: | June 2014 |
| Groups/Cohorts |
|---|
|
Diabetes
Individuals with diabetes that fit eligibility criteria.
|
|
Normal Control
Individuals without history of diabetes.
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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| Ages Eligible for Study: | 18 Years to 90 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
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.
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.
Contacts and Locations| Contact: Charleen Hollmann, PhD, RN | 646-962-2672 | chollman@med.cornell.edu |
| Contact: Mary E Yeotsas, BA | 646-962-2672 | mey2003@med.cornell.edu |
| Qatar | |
| Hamad Medical Corporation | Recruiting |
| Doha, Qatar | |
| Contact: Alya A Al-Shakaki +974-492-8445 aaa2017@qatar-med.cornell.edu | |
| Principal Investigator: Mahmoud Zirie, MD | |
| Principal Investigator: | Ronald G Crystal, MD | Weill Cornell Medical College, NY and Qatar |
More Information
No publications provided
| Responsible Party: | Ronald G. Crystal, MD, Weill Cornell Medical College - NY and Qatar |
| ClinicalTrials.gov Identifier: | NCT01172743 History of Changes |
| Other Study ID Numbers: | 0904010340, HMC Protocol # 9093/09 |
| Study First Received: | July 28, 2010 |
| Last Updated: | August 9, 2011 |
| Health Authority: | United States: Institutional Review Board Qatar: Hamad Medical Corporation |
Keywords provided by Weill Medical College of Cornell University:
|
Diabetes Mellitus Diabetes Type-2 Adult Onset |
Additional relevant MeSH terms:
|
Diabetes Mellitus Diabetes Mellitus, Type 2 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases |
ClinicalTrials.gov processed this record on May 22, 2013