Clinical trial NCT01069549: Association of AGTR1 and ACACB Gene Polymorphism and Diabetic Nephropathy in Type 2 Diabetes
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 type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes Mellitus, Type 2
Keywords: Type 2 Diabetes Mellitus
Diabetic Nephropathy
Angiotensin II type 1 receptor gene polymorphism
Acetyl coA carboxylase beta gene polymorphism.
Lead sponsor: PIMERIndia
Sponsor class: UNKNOWN
First posted: 2010-02-17
Enrollment: 476
Sex: ALL
Minimum age (years): 30
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
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.

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.


Eligibility 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 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.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Chandigarh
country: India
facility: Postgraduate Institute of Medical Education & Research
Study officials:
affiliation: Postgradute Institute of Medical Education & Research
name: anil Bhansali, DM
role: STUDY_CHAIR
References: