Epigenetic Contribution to the Pathogenesis of Diabetic Nephropathy in Qatari Population

Type 2 Diabetes Clinical Trial

Official title:

Epigenetic Contribution to the Pathogenesis of Diabetic Nephropathy in Qatari Population

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02316522
• Other study ID #: 14-00043 [JIRB]
• Status: Completed
• Start date: October 23, 2014
• Est. completion date: April 9, 2018

Study information

• Verified date: April 2022
• Source: Weill Medical College of Cornell University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 158
• Est. completion date: April 9, 2018
• Est. primary completion date: April 9, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetic Nephropathies
• Type 2 Diabetes

Locations

Country	Name	City	State
Qatar	Hamad Medical Corporation	Doha

Sponsors (3)

Lead Sponsor	Collaborator
Weill Medical College of Cornell University	Hamad Medical Corporation, Weill Cornell Medical College in Qatar

Country where clinical trial is conducted

Qatar, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	DNA methylation	Assess DNA methylation in monocytes	1 hr
Secondary	Micro-RNAs	Assess urinary micro-RNAs	1 hr