Resveratrol's Effects in Diabetic Nephropathy (ReDNeph)

October 3, 2017 updated by: Mesbah Shams, MD, Shiraz University of Medical Sciences
The aim of this study is to evaluate the safety and effects of resveratrol in treatment of diabetic nephropathy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

60

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Iran, Islamic Republic of
    • Fars
      • Shiraz, Fars, Iran, Islamic Republic of
        • Shahid Motahhari Clinic, Shiraz University of Medical Sciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Resveratrol
Resveratrol + Losartan
Drug: Resveratrol
Resveratrol 500mg daily
Drug: Losartan
Losartan 12.5mg daily
Placebo Comparator: Placebo
Placebo + Losartan
Drug: Losartan
Losartan 12.5mg daily
Drug: Placebo
Placebo 1 capsule daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Urine albumin level
Time Frame: 3 months
3 months
Serum creatinin
Time Frame: 3 months
3 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shiraz University of Medical Sciences

Investigators

  • Principal Investigator: Mesbah Shams, MD, Endocrine and Metabolism Research Center, Shiraz University of Medical Sciences
  • Study Chair: Gholamhossein Ranjbar Omrani, MD, Endocrine and Metabolism Research Center, Shiraz University of Medical Sciences
  • Principal Investigator: Jamshid Roozbeh, MD, Shiraz Nephrology and Urology Research Center, Shiraz University of Medical Sciences
  • Principal Investigator: Azar Sattarinejad, MD, Endocrine and Metabolism Research Center, Shiraz University of Medical Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2016

Primary Completion (Actual)

February 1, 2017

Study Completion (Actual)

February 1, 2017

Study Registration Dates

First Submitted

March 4, 2016

First Submitted That Met QC Criteria

March 6, 2016

First Posted (Estimate)

March 10, 2016

Study Record Updates

Last Update Posted (Actual)

October 5, 2017

Last Update Submitted That Met QC Criteria

October 3, 2017

Last Verified

October 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 93-01-49-9028

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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