Association of AGTR1 and ACACB Gene Polymorphism and Diabetic Nephropathy in Type 2 Diabetes

October 23, 2015 updated by: Anil Bhansali, Postgraduate Institute of Medical Education and Research

Study of the Association of AGTR1 and ACACB Gene Polymorphism and Susceptibility of Diabetic Nephropathy in North Indian Type 2 Diabetic Patients

India is the "Diabetes Capital of the World" with 41 million Indians having diabetes, with every fifth diabetic in the world being an Indian and type 2 Diabetes Mellitus (T2DM) constitutes the major chunk of diabetes. One of the most severe complications of diabetes is the development of diabetic nephropathy. Diabetic nephropathy (DN) is the leading cause of end-stage renal disease (ESRD) worldwide. There are many identifiable risk factors of diabetic nephropathy like hyperglycemia, hyperlipidemia, hypertension, and proteinuria, the genetic factor is the main among all. Long-term observational studies show that nearly 30-35% of type 2 diabetic patients develop nephropathy, irrespective of glycemic control. The regional variation in diabetes prevalence and in the proclivity for diabetes induced renal disease; along with reports of familial clustering of nephropathy suggest a possible genetic basis. The renin-angiotensin system (RAS) has been strongly implicated in the pathogenesis of progressive renal diseases. In addition, the blockage of angiotensin II with either ACE inhibitor or an angiotensin type-I receptor antagonist has been found to prevent or delay the progression of renal injury associated with diabetes 5 and now these drugs are first-choice drugs for the treatment of diabetic subjects with hypertension. The genes encoding the renin-angiotensin system (RAS), such as angiotensin-converting enzyme (ACE), angiotensinogen (AGT) and angiotensin II receptor type 1 (AGTR1), have been reported to be the most probable candidate genes for diabetic nephropathy. As there is no data available for AGTR1 polymorphism and DN in the north Indian T2DM, its out attempt to fill the scientific gap.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

476

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
      • Chandigarh, India, 1610012
        • Postgraduate Institute of Medical Education & Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Study Population for Group 1 and Group-2 (Subjects with diabetic nephropathy and without nephropathy respectively)will be recruited from the diabetic Out Patient and in patient services of Postgraduate Institute of Medical Education & Research and Nehru hospital, Chandigarh. Only North Indian Ethnic subjects will be recruited.

Description

Group:-1: Patients with diabetic nephropathy

Inclusion criteria:

  • Type 2 Diabetes and duration of more than or equal to 5 years.
  • Age between 30 to 85 years.
  • Presence of both albuminuria and retinopathy.

Exclusion criteria:

  • Patients with diagnosis of type 1 diabetes
  • Any known nondiabetic renal disease.
  • Patients who had a MI or had undergone CABG within 3 month.
  • Patients who had a CVA or had undergone PTCA in the previous 3 months.
  • Patients who had had a transient ischemic attack within the previous 3 months.
  • Patients who had any history of heart failure before enrollment.
  • Patients with UTI.
  • Pregnant patient.

Group:-2: Patients without diabetic nephropathy Same characteristic as group 1 but no evidence of diabetic nephropathy.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
subjects with diabetic nephropathy.

Subjects with Type 2 Diabetes. Duration of diabetes should be more than or equal to 5 years. Age between 30 and 85 years. Diabetic nephropathy as defined by ADA.

Subject must be of north Indian origin.

Type 1 diabetes and kidney disease other than diabetes nephropathy are excluded form the study.
Subjects without Diabetic nephropathy.
This group of subject with similar characteristics as group 1 without any evidence of nephropathy.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Postgraduate Institute of Medical Education and Research

Investigators

  • Study Chair: anil Bhansali, DM, Postgradute Institute of Medical Education & Research

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2009

Primary Completion (Actual)

April 1, 2011

Study Completion (Actual)

May 1, 2011

Study Registration Dates

First Submitted

February 16, 2010

First Submitted That Met QC Criteria

February 16, 2010

First Posted (Estimate)

February 17, 2010

Study Record Updates

Last Update Posted (Estimate)

October 26, 2015

Last Update Submitted That Met QC Criteria

October 23, 2015

Last Verified

October 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AT1RGPT2DM

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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