Resveratrol's Effects in Diabetic Nephropathy

Early Phase 1

Completed

• Conditions: Diabetic Nephropathy
• Interventions: Drug: Placebo; Drug: Resveratrol; Drug: Losartan

• Registration Number: NCT02704494
• Lead Sponsor: Shiraz University of Medical Sciences

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.

Study Timeline

• Study Start: 2016-03
• Study First Submitted: 2016-03-04
• Study First Submitted QC: 2016-03-06
• Study First Posted: 2016-03-10
• Primary Completion: 2017-02
• Study Completion: 2017-02
• Status Verified: 2017-10
• Last Update Submitted: 2017-10-03
• Last Update Posted: 2017-10-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Resveratrol	Losartan	Resveratrol + Losartan
Placebo	Placebo	Placebo + Losartan
Placebo	Losartan	Placebo + Losartan
Resveratrol	Resveratrol	Resveratrol + Losartan

Primary Outcome Measures

Name	Time	Method
Serum creatinin	3 months
Urine albumin level	3 months

Secondary Outcome Measures

Name	Time	Method
Liver aminotransferases (ALT and AST)	3 months
Fasting blood sugar (FBS)	3 months
Glycosylated hemoglobin (A1C)	3 months
Serum insulin level	3 months
Number of patients with adverse events	3 months

Trial Locations

Locations (1)

Shahid Motahhari Clinic, Shiraz University of Medical Sciences; 🇮🇷 Shiraz, Fars, Iran, Islamic Republic of