- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02021695
DNA Methylation and Gene Expression in Qataris With Type 2 Diabetes
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Doha, Qatar
- Hamad Medical Corporation
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Must provide informed consent
- Males or Females aged 30 years or older to minimize the potential confounding of other forms of diabetes mellitus
- In patients with diabetes, no concomitant diseases except for micro- and macrovascular complications of diabetes (nephropathy, retinopathy, peripheral arterial disease, coronary artery disease, neuropathy) or symptoms of the metabolic syndrome (hypertension, dyslipidemia and obesity)
- Not taking any chronic medications (except of the diabetes and cardiovascular related drugs).
Exclusion Criteria:
- Diagnosis of Type-I Diabetes
- Active situational diabetes (steroids use/pregnancy)
- Active infection or acute illness of any kind
- Chronic inflammation (auto-immune diseases) or infection
- Evidence of malignancy within the past 5 years
Chronic hematological disorders known to affect glycated hemoglobin results such as hemoglobinopathies (e.g. sickle cell disease and thalassemia), increases red-cell turnover (e.g. hemolytic anemia and spherocytosis.
- Evidence of malignancy within the past 5 years
- Chronic hematological disorders known to affect glycated hemoglobin results such as hemoglobinopathies
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Group I: Non-diabetic controls
Group I: Non-diabetic controls Good overall health without history of Type II diabetes. Normal fasting glucose level (<100 mg/dL) and HbA1C < 5.7% Also:
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Group II: Diabetic with HbA1C<7%
Group II: HbA1C<7% Also:
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Group III: Good controlled diabetics with 7 % <HbA1C < 10%
Group III Good controlled diabetics with 7 % <HbA1C < 10% Also:
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Group IV: Poorly controlled diabetics with HbA1C > 10%.
Group IV: Poorly controlled diabetics with HbA1C > 10%. Also:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
DNA methylation and gene expression in blood monocytes and lymphocytes
Time Frame: 1 hour
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Changes in DNA methylation and gene expression in blood monocytes and lymphocytes will be compared in healthy, diabetic and pre-diabetic subjects.
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1 hour
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Collaborators and Investigators
Investigators
- Principal Investigator: Charbel Abi Khalil, MD, Weill Cornell Medical College in Qatar
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 13-00023 [JIRB]
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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