Epigenetic Contribution to the Pathogenesis of Diabetic Nephropathy in Qatari Population

NCT ID: NCT02316522

Last Updated: 2022-05-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

158 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-10-23

Study Completion Date

2018-04-09

Brief Summary

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

Detailed Description

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Diabetic nephropathy (DN) is a common vascular complication of Type 2 diabetes (T2D) that is associated with increased mortality and poor quality of life.In industrialized countries, DN ranges first among other etiologies of end-stage renal disease (ESRD).Diabetes in Qatar is a serious health issue for the Qatari population since approximately 1/5 of the population has T2D, which is 2-3 times higher than the world average. As observed in other Gulf cooperation council (GCC) countries, obesity and sedentary lifestyle are cornerstones in the development of T2D. Additionally, consanguineous marriages in Qatar contribute to this high prevalence. As a consequence, DN has an enormous burden in terms of management, treatment and especially in renal replacement therapy (RRT) in ESRD in Qatari Population.DN is a glomerular disease defined by increased urinary albumin excretion (UAE), hypertension and decline in the glomerular filtration rate (GFR), all induced by chronic hyperglycemia. However, there are other contributing factors such as genetic predisposition, systemic and intra-renal hemodynamic disturbances, all leading to glomerulosclerosis. All of the known pathways do not explain the complex pathophysiology behind DN. Even different variants of genes described in major GWAS studies have little impact in terms of risk prevention or prognosis of DN. Over the last decade, epigenetics have initiated a new era in Genetic Medicine capable of giving a different approach to human disease.

Conditions

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Type 2 Diabetes

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Group I: T2D nephropathy

Individuals with type 2 diabetes and nephropathy

No interventions assigned to this group

Group II: T2D and no nephropathy

Individuals with type 2 diabetes and no nephropathy

No interventions assigned to this group

Group III: Control, non-diabetic

Non-diabetic individuals with normal kidney function

No interventions assigned to this group

Group IV: Controls, non-diabetic

Non-diabetic individuals with hypertensive nephropathy

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* 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.

* 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

Exclusion Criteria

* Type I diabetes or other form of diabetes (MODY, secondary diabetes)
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Hamad Medical Corporation

INDUSTRY

Sponsor Role collaborator

Weill Cornell Medical College in Qatar

OTHER

Sponsor Role collaborator

Weill Medical College of Cornell University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Charbel Abi Khalil, MD

Role: PRINCIPAL_INVESTIGATOR

Weill Cornell Medical College in Qatar

Locations

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Hamad Medical Corporation

Doha, , Qatar

Site Status

Countries

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Qatar

Other Identifiers

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14-00043 [JIRB]

Identifier Type: -

Identifier Source: org_study_id

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