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

NCT ID: NCT01172743

Last Updated: 2020-07-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

450 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-06-30

Study Completion Date

2020-07-31

Brief Summary

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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

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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.

Conditions

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Diabetes Mellitus Type 2 Diabetes Mellitus

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Diabetes

Individuals with diabetes that fit eligibility criteria.

No interventions assigned to this group

Normal Control

Individuals without history of diabetes.

No interventions assigned to this group

Eligibility Criteria

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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.


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

Exclusion Criteria

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

Normal control group


* Individual refuses consent.
* Individuals with history of diabetes.
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Weill Cornell Medical College in Qatar

OTHER

Sponsor Role collaborator

Hamad Medical Corporation

INDUSTRY

Sponsor Role collaborator

Weill Medical College of Cornell University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ronald G Crystal, MD

Role: STUDY_DIRECTOR

Weill Cornell Medical College, NY and Qatar

Locations

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Hamad Medical Corporation

Doha, , Qatar

Site Status

Countries

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Qatar

Other Identifiers

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HMC Protocol # 9093/09

Identifier Type: OTHER

Identifier Source: secondary_id

0904010340

Identifier Type: -

Identifier Source: org_study_id

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