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

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ClinicalTrials.gov Identifier: NCT01069549
Recruitment Status : Completed
First Posted : February 17, 2010
Last Update Posted : October 26, 2015
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease
Diabetes Mellitus, Type 2

Study Design

Study Type : Observational
Actual Enrollment : 476 participants
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
Study Start Date : November 2009
Primary Completion Date : April 2011
Study Completion Date : May 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and 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 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.

Outcome Measures

Biospecimen Retention:   Samples With DNA
4 ml of whole blood sample.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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.

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.

Contacts and Locations

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): NCT01069549

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

Responsible Party: Anil Bhansali, prof and head, Postgraduate Institute of Medical Education and Research
ClinicalTrials.gov Identifier: NCT01069549     History of Changes
Other Study ID Numbers: AT1RGPT2DM
First Posted: February 17, 2010    Key Record Dates
Last Update Posted: October 26, 2015
Last Verified: October 2015

Keywords provided by Anil Bhansali, Postgraduate Institute of Medical Education and Research:
Type 2 Diabetes Mellitus
Diabetic Nephropathy
Angiotensin II type 1 receptor gene polymorphism
Acetyl coA carboxylase beta gene polymorphism.

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