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Completed

NCT Number: NCT02704494

Resveratrol's Effects in Diabetic Nephropathy

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

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Key information

Conditions

Diabetic Nephropathy Albuminuria Diabetes Complications Diabetes Mellitus Diabetic Nephropathies Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Glucose Metabolism Disorders Kidney Diseases Male Urogenital Diseases Metabolic Diseases Nutritional and Metabolic Diseases Pathological Conditions, Signs and Symptoms Proteinuria Renal Insufficiency Signs and Symptoms Urination Disorders Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Shahid Motahhari Clinic, Shiraz University of Medical Sciences

Shiraz, Fars, Iran

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Resveratrol

Drug

Resveratrol 500mg daily

Placebo

Drug

Placebo 1 capsule daily

Losartan

Drug

Losartan 12.5mg daily

Primary outcomes

  1. Urine albumin level

    Time frame: 3 months

  2. Serum creatinin

    Time frame: 3 months

Secondary outcomes

  1. Fasting blood sugar (FBS)

    Time frame: 3 months

  2. Glycosylated hemoglobin (A1C)

    Time frame: 3 months

  3. Liver aminotransferases (ALT and AST)

    Time frame: 3 months

  4. Serum insulin level

    Time frame: 3 months

  5. Number of patients with adverse events

    Time frame: 3 months

Sponsors and collaborators

Lead sponsor

Shiraz University of Medical Sciences

Other

Registry information

Acronym: ReDNeph

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Mar 10, 2016
Registry last updated
Oct 5, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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