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

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2013 by Weill Medical College of Cornell University
Sponsor:
Collaborators:
Weill Cornell Medical College in Qatar
Hamad Medical Corporation
Information provided by (Responsible Party):
Weill Medical College of Cornell University
ClinicalTrials.gov Identifier:
NCT01172743
First received: July 28, 2010
Last updated: November 22, 2013
Last verified: November 2013
  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)

Resource links provided by NLM:


Further study details as provided by Weill Medical College of Cornell University:

Biospecimen Retention:   Samples With DNA

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.

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
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.

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01172743

Contacts
Contact: Charleen Hollmann, PhD, RN 646-962-2672 chollman@med.cornell.edu
Contact: Denesy Mancenido, BA 646-962-4537 dem2026@med.cornell.edu

Locations
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         
Sponsors and Collaborators
Weill Medical College of Cornell University
Weill Cornell Medical College in Qatar
Hamad Medical Corporation
Investigators
Principal Investigator: Ronald G Crystal, MD Weill Cornell Medical College, NY and Qatar
  More Information

No publications provided

Responsible Party: Weill Medical College of Cornell University
ClinicalTrials.gov Identifier: NCT01172743     History of Changes
Other Study ID Numbers: 0904010340, HMC Protocol # 9093/09
Study First Received: July 28, 2010
Last Updated: November 22, 2013
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 July 29, 2014