Epigenetic Contribution to the Pathogenesis of Diabetic Nephropathy in Qatari Population

NCT02316522 | Completed DMC

• 1 other identifier: 14-00043 [JIRB]
• Study Type: observational
• Target: 158
• Locations: 1 country
• Sites: 1

Brief Summary

The main objective is to study the epigenetic contribution to the pathophysiology of diabetic nephropathy in Qatari population.

Conditions

Type 2 Diabetes

Outcome Measures

Primary Outcomes (1)

• DNA methylation

  Assess DNA methylation in monocytes

  1 hr

Secondary Outcomes (1)

• Micro-RNAs

  1 hr

Study Arms (4)

Group I: T2D nephropathy

Individuals with type 2 diabetes and nephropathy

Group II: T2D and no nephropathy

Individuals with type 2 diabetes and no nephropathy

Group III: Control, non-diabetic

Non-diabetic individuals with normal kidney function

Group IV: Controls, non-diabetic

Non-diabetic individuals with hypertensive nephropathy

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects will be recruited from Hamad Medical Corporation.

You may qualify if:

• Males and females, at least 18 years old
• Provide informed consent
• Willingness to participate in the study
• 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 the cardiovascular related drugs)
• Consent to having peripheral blood and urine collection for DNA extraction and micro-RNAs as well as routine laboratory evaluation, including general hematologic studies, general biochemical analyses.

You may not qualify if:

• Type I diabetes or other form of diabetes (MODY, secondary diabetes)
• Pregnancy
• Active infection or acute illness of any kind
• Chronic inflammation (auto-immune diseases) or infections (HIV, chronic viral hepatitis, chronic urinary tract infections …)
• Evidence of malignancy within the past 5 years
• Chronic hematological disorders known to affect glycated hemoglobin results such as hemoglobinopathies and pathologies with high red-cell turnover

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 Urine

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: December 9, 2014
• First Posted: December 15, 2014
• Study Start: October 23, 2014
• Primary Completion: April 9, 2018
• Study Completion: April 9, 2018
• Last Updated: May 2, 2022

Record last verified: 2022-04

Locations

QA (1)