DNA Methylation and Gene Expression in Qataris With Type 2 Diabetes

NCT02021695 | Completed DMC

• 1 other identifier: 13-00023 [JIRB]
• Study Type: observational
• Target: 249
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 2 Diabetes

Outcome Measures

Primary Outcomes (1)

• DNA methylation and gene expression in blood monocytes and lymphocytes

  Changes in DNA methylation and gene expression in blood monocytes and lymphocytes will be compared in healthy, diabetic and pre-diabetic subjects.

  1 hour

Study Arms (4)

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).

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Weill Medical College of Cornell University: lead
• Hamad Medical Corporation: collaborator
• Weill Cornell Medical College in Qatar: collaborator

Study Sites (1)

Hamad Medical Corporation

Doha, Qatar

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Charbel Abi Khalil, MD

  Weill Cornell Medical College in Qatar

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: November 22, 2013
• First Posted: December 27, 2013
• Study Start: September 1, 2013
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2021
• Last Updated: January 27, 2022

Record last verified: 2022-01

Locations

QA (1)