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

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01069549
• Other study ID #: AT1RGPT2DM
• Status: Completed
• Phase: N/A
• First received: February 16, 2010
• Last updated: October 23, 2015
• Start date: November 2009
• Est. completion date: May 2011

Study information

• Verified date: October 2015
• Source: Postgraduate Institute of Medical Education and Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 476
• Est. completion date: May 2011
• Est. primary completion date: April 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 85 Years

Eligibility

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 Design

Observational Model: Case Control, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Diabetic Nephropathies
• Kidney Diseases

Locations

Country	Name	City	State
India	Postgraduate Institute of Medical Education & Research	Chandigarh

Sponsors (1)

Lead Sponsor	Collaborator
Postgraduate Institute of Medical Education and Research

Country where clinical trial is conducted

India,