NCT01172743

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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
450

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2009

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2009

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

July 28, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 30, 2010

Completed
9.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2020

Completed
Last Updated

July 31, 2020

Status Verified

July 1, 2020

Enrollment Period

11.1 years

First QC Date

July 28, 2010

Last Update Submit

July 29, 2020

Conditions

Keywords

Diabetes MellitusDiabetesType-2Adult Onset

Study Arms (2)

Diabetes

Individuals with diabetes that fit eligibility criteria.

Normal Control

Individuals without history of diabetes.

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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.

You may not qualify if:

  • Individual refuses consent
  • Pregnant females with gestational diabetes
  • Type-I diabetes
  • Normal control group
  • Must provide informed consent
  • Males or females ages 18 years and older
  • Resolved gestational diabetes
  • Individual refuses consent.
  • Individuals with history of diabetes.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hamad Medical Corporation

Doha, Qatar

Location

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.

MeSH Terms

Conditions

Diabetes MellitusDiabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Ronald G Crystal, MD

    Weill Cornell Medical College, NY and Qatar

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 28, 2010

First Posted

July 30, 2010

Study Start

June 1, 2009

Primary Completion

July 1, 2020

Study Completion

July 1, 2020

Last Updated

July 31, 2020

Record last verified: 2020-07

Locations