Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
EARLY_PHASE1
60 participants
INTERVENTIONAL
2016-03-31
2017-02-28
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Resveratrol
Resveratrol + Losartan
Resveratrol
Resveratrol 500mg daily
Losartan
Losartan 12.5mg daily
Placebo
Placebo + Losartan
Placebo
Placebo 1 capsule daily
Losartan
Losartan 12.5mg daily
Interventions
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Resveratrol
Resveratrol 500mg daily
Placebo
Placebo 1 capsule daily
Losartan
Losartan 12.5mg daily
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
70 Years
ALL
No
Sponsors
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Shiraz University of Medical Sciences
OTHER
Responsible Party
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Mesbah Shams, MD
Associate professor of internal medicine and endocrinology
Principal Investigators
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Gholamhossein Ranjbar Omrani, MD
Role: STUDY_CHAIR
Endocrine and Metabolism Research Center, Shiraz University of Medical Sciences
Jamshid Roozbeh, MD
Role: PRINCIPAL_INVESTIGATOR
Shiraz Nephrology and Urology Research Center, Shiraz University of Medical Sciences
Azar Sattarinejad, MD
Role: PRINCIPAL_INVESTIGATOR
Endocrine and Metabolism Research Center, Shiraz University of Medical Sciences
Mesbah Shams, MD
Role: PRINCIPAL_INVESTIGATOR
Endocrine and Metabolism Research Center, Shiraz University of Medical Sciences
Locations
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Shahid Motahhari Clinic, Shiraz University of Medical Sciences
Shiraz, Fars, Iran
Countries
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References
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Colombijn JM, Hooft L, Jun M, Webster AC, Bots ML, Verhaar MC, Vernooij RW. Antioxidants for adults with chronic kidney disease. Cochrane Database Syst Rev. 2023 Nov 2;11(11):CD008176. doi: 10.1002/14651858.CD008176.pub3.
Sattarinezhad A, Roozbeh J, Shirazi Yeganeh B, Omrani GR, Shams M. Resveratrol reduces albuminuria in diabetic nephropathy: A randomized double-blind placebo-controlled clinical trial. Diabetes Metab. 2019 Jan;45(1):53-59. doi: 10.1016/j.diabet.2018.05.010. Epub 2018 Jun 8.
Other Identifiers
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93-01-49-9028
Identifier Type: -
Identifier Source: org_study_id