Resveratrol's Effects in Diabetic Nephropathy

Diabetic Nephropathy Clinical Trial

— ReDNeph  

Official title:

Resveratrol's Effects in Diabetic Nephropathy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02704494
• Other study ID #: 93-01-49-9028
• Status: Completed
• Phase: Early Phase 1
• First received: March 4, 2016
• Last updated: October 3, 2017
• Start date: March 2016
• Est. completion date: February 2017

Study information

• Verified date: October 2017
• Source: Shiraz University of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: February 2017
• Est. primary completion date: February 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetic Nephropathies
• Diabetic Nephropathy
• Kidney Diseases

Intervention

Drug:
• Resveratrol
Resveratrol 500mg daily
• Placebo
Placebo 1 capsule daily
• Losartan
Losartan 12.5mg daily

Locations

Country	Name	City	State
Iran, Islamic Republic of	Shahid Motahhari Clinic, Shiraz University of Medical Sciences	Shiraz	Fars

Sponsors (1)

Lead Sponsor	Collaborator
Shiraz University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Urine albumin level		3 months
Primary	Serum creatinin		3 months
Secondary	Fasting blood sugar (FBS)		3 months
Secondary	Glycosylated hemoglobin (A1C)		3 months
Secondary	Liver aminotransferases (ALT and AST)		3 months
Secondary	Serum insulin level		3 months
Secondary	Number of patients with adverse events		3 months