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Epigenetic Contribution to the Pathogenesis of Diabetic Nephropathy in Qatari Population

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ClinicalTrials.gov Identifier: NCT02316522
Recruitment Status : Recruiting
First Posted : December 15, 2014
Last Update Posted : April 30, 2018
Sponsor:
Collaborators:
Hamad Medical Corporation
Weill Cornell Medical College in Qatar
Information provided by (Responsible Party):
Weill Medical College of Cornell University

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

Condition or disease
Type 2 Diabetes

Detailed Description:
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.

Study Type : Observational
Estimated Enrollment : 240 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Epigenetic Contribution to the Pathogenesis of Diabetic Nephropathy in Qatari Population
Study Start Date : May 2014
Estimated Primary Completion Date : February 2019
Estimated Study Completion Date : February 2019

Resource links provided by the National Library of Medicine


Group/Cohort
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



Primary Outcome Measures :
  1. DNA methylation [ Time Frame: 1 hr ]
    Assess DNA methylation in monocytes


Secondary Outcome Measures :
  1. Micro-RNAs [ Time Frame: 1 hr ]
    Assess urinary micro-RNAs


Biospecimen Retention:   Samples With DNA
Blood Urine


Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Subjects will be recruited from Hamad Medical Corporation.
Criteria

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.

Exclusion Criteria:

  • Type I diabetes or other form of diabetes (MODY, secondary diabetes)
  • Unable to meet the inclusion criteria
  • 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

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): NCT02316522


Contacts
Contact: Grace Mammen, BA, CCRP 646-962-2672 gwm2004@med.cornell.edu
Contact: Amal Robay, PhD, CCRP +974-4492-8494 amr2018@qatar-med.cornell.edu

Locations
Qatar
Hamad Medical Corporation Recruiting
Doha, Qatar
Contact: Amal Robay, PhD    +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
Principal Investigator: Charbel Abi Khalil, MD Weill Cornell Medical College in Qatar

Responsible Party: Weill Medical College of Cornell University
ClinicalTrials.gov Identifier: NCT02316522     History of Changes
Other Study ID Numbers: 14-00043 [JIRB]
First Posted: December 15, 2014    Key Record Dates
Last Update Posted: April 30, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
Diabetic Nephropathies
Kidney Diseases
Urologic Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases