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

This study has been completed.
Sponsor:
Information provided by:
Postgraduate Institute of Medical Education and Research
ClinicalTrials.gov Identifier:
NCT01069549
First received: February 16, 2010
Last updated: May 23, 2011
Last verified: January 2010
  Purpose

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.


Condition
Diabetes Mellitus, Type II

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: Study of the Association of AGTR1 and ACACB Gene Polymorphism and Susceptibility of Diabetic Nephropathy in North Indian Type 2 Diabetic Patients

Resource links provided by NLM:


Further study details as provided by Postgraduate Institute of Medical Education and Research:

Biospecimen Retention:   Samples With DNA

4 ml of whole blood sample.


Enrollment: 476
Study Start Date: November 2009
Study Completion Date: May 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
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 70 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.

  Eligibility

Ages Eligible for Study:   30 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

Criteria

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 70 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.

  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01069549

Locations
India
Postgraduate Institute of Medical Education & Research
Chandigarh, India, 1610012
Sponsors and Collaborators
Postgraduate Institute of Medical Education and Research
Investigators
Study Chair: anil Bhansali, DM Postgradute Institute of Medical Education & Research
  More Information

No publications provided

Responsible Party: dr. Anil Bhansali DM, Postgraduate Institute of Medical Education and Research
ClinicalTrials.gov Identifier: NCT01069549     History of Changes
Other Study ID Numbers: AT1RGPT2DM
Study First Received: February 16, 2010
Last Updated: May 23, 2011
Health Authority: India: Institutional Review Board

Keywords provided by Postgraduate Institute of Medical Education and Research:
Type II Diabetes Mellitus
Diabetes Nephropathy
Angiotensin type II receptor gene polymorphism.

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Diabetic Nephropathies
Kidney Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Urologic Diseases
Diabetes Complications

ClinicalTrials.gov processed this record on July 24, 2014