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DNA Methylation and Gene Expression in Qataris With Type 2 Diabetes

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ClinicalTrials.gov Identifier: NCT02021695
Recruitment Status : Recruiting
First Posted : December 27, 2013
Last Update Posted : April 24, 2020
Sponsor:
Collaborators:
Hamad Medical Corporation
Weill Cornell Medical College in Qatar
Information provided by (Responsible Party):
Weill Medical College of Cornell University

Study Description
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Brief Summary:
With the assessment of the healthy vs. diabetic and pre-diabetic Qatari population the investigators intend to measure the changes in DNA methylation and gene expression in blood monocytes and lymphocytes attributed to diabetes, and to evaluate whether theses changes are persistent or can be reversed by improving diabetes control.

Condition or disease
Type 2 Diabetes

Detailed Description:
The global prevalence of Type 2 Diabetes (T2D) is rapidly rising throughout most regions of the developed and developing world. In Middle East countries, particularly in the Gulf Council countries, the diabetes pandemic along with the rates of obesity have risen due to the adoption of a modern lifestyle. In the Qatari population alone, T2D is highly prevalent as 18% of the Qatari adults are estimated to suffer from this disease. Consanguineous marriages, sedentary lifestyle, obesity and bad dietary habits are cited as the main causes for this high incidence rate. Chronic hyperglycemia caused by long-term uncontrolled diabetes state can lead to devastating complications such as cardiovascular diseases, neuropathy, and retinopathy. Such complications are also highly prevalent in the Qatari population, perhaps due to the relatively low adherence to clinical guidelines but vary among Qatari individuals based on their genetic predisposition and shared family environment.It is already known that inflammation is part of the complex biochemical process of initiating and further developing cardiovascular complications of diabetes. Experimental models have showed that exposure to hyperglycemia induces epigenomic changes in inflammatory pathways, which subsequently regulate gene expression leading to the development of vascular inflammation. The investigators therefore hypothesized that chronic hyperglycemia leads to altered DNA methylation and dysregulation of gene expression in peripheral blood monocytes and lymphocytes in patients with type 2 diabetes.
Study Design
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Study Type : Observational
Estimated Enrollment : 280 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: DNA Methylation and Gene Expression in Qataris With Type 2 Diabetes
Study Start Date : September 2013
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : June 2022

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort
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:

  1. Must provide informed consent
  2. Males or Females aged 30 years or older to minimize the potential confounding of other forms of diabetes mellitus
  3. 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)
  4. Not taking any chronic medications (except of the diabetes and cardiovascular related drugs).
Group II: Diabetic with HbA1C<7%

Group II:

HbA1C<7%

Also:

  1. Must provide informed consent
  2. Males or Females aged 30 years or older to minimize the potential confounding of other forms of diabetes mellitus
  3. 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)
  4. Not taking any chronic medications (except of the diabetes and cardiovascular related drugs).
Group III: Good controlled diabetics with 7 % <HbA1C < 10%

Group III Good controlled diabetics with 7 % <HbA1C < 10%

Also:

  1. Must provide informed consent
  2. Males or Females aged 30 years or older to minimize the potential confounding of other forms of diabetes mellitus
  3. 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)
  4. Not taking any chronic medications (except of the diabetes and cardiovascular related drugs).
Group IV: Poorly controlled diabetics with HbA1C > 10%.

Group IV:

Poorly controlled diabetics with HbA1C > 10%.

Also:

  1. Must provide informed consent
  2. Males or Females aged 30 years or older to minimize the potential confounding of other forms of diabetes mellitus
  3. 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)
  4. Not taking any chronic medications (except of the diabetes and cardiovascular related drugs).


Outcome Measures
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Primary Outcome Measures :
  1. DNA methylation and gene expression in blood monocytes and lymphocytes [ Time Frame: 1 hour ]
    Changes in DNA methylation and gene expression in blood monocytes and lymphocytes will be compared in healthy, diabetic and pre-diabetic subjects.


Biospecimen Retention:   Samples With DNA
Blood

Eligibility Criteria
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Ages Eligible for Study:   30 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Subjects will be recruited for the study at Hamad Medical Corporation. Most of the subjects will belong to the outpatients clinics. However, the subjects with bad Diabetes control might be recruited from the inpatient clinic as well.
Criteria

Inclusion Criteria:

  1. Must provide informed consent
  2. Males or Females aged 30 years or older to minimize the potential confounding of other forms of diabetes mellitus
  3. 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)
  4. Not taking any chronic medications (except of the diabetes and cardiovascular related drugs).

Exclusion Criteria:

  1. Diagnosis of Type-I Diabetes
  2. Active situational diabetes (steroids use/pregnancy)
  3. Active infection or acute illness of any kind
  4. Chronic inflammation (auto-immune diseases) or infection
  5. Evidence of malignancy within the past 5 years

  6. 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02021695


Contacts
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Contact: Grace Mammen, BA, CCRP 6469622672 gwm2004@med.cornell.edu
Contact: Amal Robay, PhD, CCRP +974-4492-8494 amr2018@qatar-med.cornell.edu

Locations
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Qatar
Hamad Medical Corporation Recruiting
Doha, Qatar
Contact: Amal Robay    +974-4492-8494    amr2018@qatar-med.cornell.edu   
Principal Investigator: Charbel Abi Khalil, MD         
Sponsors and Collaborators
Weill Medical College of Cornell University
Hamad Medical Corporation
Weill Cornell Medical College in Qatar
Investigators
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Principal Investigator: Charbel Abi Khalil, MD Weill Cornell Medical College in Qatar
More Information
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Responsible Party: Weill Medical College of Cornell University
ClinicalTrials.gov Identifier: NCT02021695    
Other Study ID Numbers: 13-00023 [JIRB]
First Posted: December 27, 2013    Key Record Dates
Last Update Posted: April 24, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases