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Resveratrol's Effects in Diabetic Nephropathy

Resveratrol's Effects in Diabetic Nephropathy

Status
Completed
Phases
Early Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02704494
Acronym
ReDNeph
Enrollment
60
Registered
2016-03-10
Start date
2016-03-31
Completion date
2017-02-28
Last updated
2017-10-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetic Nephropathy

Keywords

Resveratrol, Diabetes mellitus, Diabetes complications, Diabetic nephropathies, Proteinuria, Albuminuria, renal insufficiency

Brief summary

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

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.

Interventions

DRUGResveratrol

Resveratrol 500mg daily

DRUGPlacebo

Placebo 1 capsule daily

DRUGLosartan

Losartan 12.5mg daily

Sponsors

Shiraz University of Medical Sciences
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Urine albumin level3 months
Serum creatinin3 months

Secondary

MeasureTime frame
Fasting blood sugar (FBS)3 months
Serum insulin level3 months
Liver aminotransferases (ALT and AST)3 months
Glycosylated hemoglobin (A1C)3 months
Number of patients with adverse events3 months

Countries

Iran

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 6, 2026