Resveratrol's Effects in Diabetic Nephropathy (ReDNeph)

Shiraz University of Medical Sciences

Status and phase: Completed; Early Phase 1

Conditions: Diabetic Nephropathy

Treatments: Drug: Placebo; Drug: Resveratrol; Drug: Losartan

Study type: Interventional

Funder types: Other

Identifiers

NCT02704494

93-01-49-9028

Details and patient eligibility

About

The aim of this study is to evaluate the safety and effects of resveratrol in treatment of diabetic nephropathy.

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

60 participants in 2 patient groups, including a placebo group

Resveratrol

Experimental group

Description:

Resveratrol + Losartan

Treatment:

Drug: Resveratrol

Drug: Losartan

Placebo

Placebo Comparator group

Description:

Placebo + Losartan

Treatment:

Drug: Placebo

Drug: Losartan