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Resveratrol's Effects in Diabetic Nephropathy (ReDNeph)

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ClinicalTrials.gov Identifier: NCT02704494
Recruitment Status : Completed
First Posted : March 10, 2016
Last Update Posted : October 5, 2017
Sponsor:
Information provided by (Responsible Party):
Mesbah Shams, MD, 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.

Condition or disease Intervention/treatment Phase
Diabetic Nephropathy Drug: Resveratrol Drug: Placebo Drug: Losartan Early Phase 1

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  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Resveratrol's Effects in Diabetic Nephropathy
Actual Study Start Date : March 2016
Actual Primary Completion Date : February 2017
Actual Study Completion Date : February 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Resveratrol
Resveratrol + Losartan
Drug: Resveratrol
Resveratrol 500mg daily

Drug: Losartan
Losartan 12.5mg daily

Placebo Comparator: Placebo
Placebo + Losartan
Drug: Placebo
Placebo 1 capsule daily

Drug: Losartan
Losartan 12.5mg daily




Primary Outcome Measures :
  1. Urine albumin level [ Time Frame: 3 months ]
  2. Serum creatinin [ Time Frame: 3 months ]

Secondary Outcome Measures :
  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 ]


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02704494


Locations
Iran, Islamic Republic of
Shahid Motahhari Clinic, Shiraz University of Medical Sciences
Shiraz, Fars, Iran, Islamic Republic of
Sponsors and Collaborators
Shiraz University of Medical Sciences
Investigators
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
Principal Investigator: Mesbah Shams, MD Endocrine and Metabolism Research Center, Shiraz University of Medical Sciences

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Mesbah Shams, MD, Associate professor of internal medicine and endocrinology, Shiraz University of Medical Sciences
ClinicalTrials.gov Identifier: NCT02704494     History of Changes
Other Study ID Numbers: 93-01-49-9028
First Posted: March 10, 2016    Key Record Dates
Last Update Posted: October 5, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Mesbah Shams, MD, Shiraz University of Medical Sciences:
Resveratrol
Diabetes mellitus
Diabetes complications
Diabetic nephropathies
Proteinuria
Albuminuria
renal insufficiency

Additional relevant MeSH terms:
Kidney Diseases
Diabetic Nephropathies
Urologic Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Losartan
Resveratrol
Anti-Arrhythmia Agents
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Antioxidants
Protective Agents
Enzyme Inhibitors
Platelet Aggregation Inhibitors
Antimutagenic Agents
Anticarcinogenic Agents