Resveratrol's Effects in Diabetic Nephropathy

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to evaluate the safety and effects of resveratrol in treatment of diabetic nephropathy.

Detailed Description
-----------------
Diabetes mellitus (DM) is one of the most important public health burdens, and its prevalence has rapidly increased worldwide over the past decades. One of the most important complications of DM is nephropathy. Resveratrol (3, 5, 4'-trihydroxystilbene) is a natural polyphenolic compound belongs to the large group of polyphenols found in different plant species. The richest natural source of resveratrol is Polygonum cuspidatum - a plant root extract of which have been used in oriental folk medicine. Considerable amounts of resveratrol were also found in skin of red grapes, peanuts, groundnuts, and red vine. Resveratrol is considered to have beneficial effects on glucose tolerance and insulin sensitivity, the cardiovascular system, as it has been found to improve vasodilatation, ischaemic preconditioning, both of which seem to be the result of the activation of the endothelial NO synthase enzyme, and to inhibit both platelet aggregation and vascular smooth muscle cell proliferation. Resveratrol itself is an efficient antioxidant, as evidenced by both in vitro and in vivo studies, and, it has also been shown to improve diabetes-related impairments in animals. We hypothesized that resveratrol may have a favorable effects on control of diabetic nephropathy. The aim of this study is to evaluate the safety and effects of resveratrol in treatment of diabetic nephropathy.

Official Title
-----------------
Resveratrol's Effects in Diabetic Nephropathy

Conditions
-----------------
Diabetic Nephropathy

Intervention / Treatment
-----------------
* Drug: Resveratrol
* Drug: Placebo
* Drug: Losartan


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Type 2 diabetes mellitus (DM) Controlled blood sugar [fasting blood sugar (FBS) <130mg/dl and glycosylated hemoglobin (A1C)<7% Urine albumin >20mg/lit in two separate occasions during the last 3 months period Serum creatinin < or = 2mg/dl Exclusion Criteria: Pregnancy Lactation Alcoholism Liver failure (acute or chronic) Renal failure: serum creatinin >2mg/dl Glomerulonephritis Uncontrolled hypertension Congestive heart failure Prostate disease Malignancy Bilateral renal artery stenosis Any systemic disease other than DM Any infection or rheumatologic disorder Use of warfarin

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Resveratrol<br>Resveratrol + Losartan | Drug: Resveratrol<br>* Resveratrol 500mg daily<br>Drug: Losartan<br>* Losartan 12.5mg daily<br>|
| Placebo Comparator: Placebo<br>Placebo + Losartan | Drug: Placebo<br>* Placebo 1 capsule daily<br>Drug: Losartan<br>* Losartan 12.5mg daily<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Urine albumin level |  | 3 months | 
| Serum creatinin |  | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fasting blood sugar (FBS) |  | 3 months | 
| Glycosylated hemoglobin (A1C) |  | 3 months | 
| Liver aminotransferases (ALT and AST) |  | 3 months | 
| Serum insulin level |  | 3 months | 
| Number of patients with adverse events |  | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Resveratrol, Diabetes mellitus, Diabetes complications, Diabetic nephropathies, Proteinuria, Albuminuria, renal insufficiency