Clinical trial NCT02704494: Resveratrol's Effects in Diabetic Nephropathy
Official title: Resveratrol's Effects in Diabetic Nephropathy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Diabetic Nephropathy
Keywords: Resveratrol
Diabetes mellitus
Diabetes complications
Diabetic nephropathies
Proteinuria
Albuminuria
renal insufficiency
Lead sponsor: Shiraz University of Medical Sciences
Sponsor class: OTHER
First posted: 2016-03-10
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Urine albumin level
timeFrame: 3 months
measure: Serum creatinin
timeFrame: 3 months
Secondary outcomes:
measure: Fasting blood sugar (FBS)
timeFrame: 3 months
measure: Glycosylated hemoglobin (A1C)
timeFrame: 3 months
measure: Liver aminotransferases (ALT and AST)
timeFrame: 3 months
measure: Serum insulin level
timeFrame: 3 months
measure: Number of patients with adverse events
timeFrame: 3 months
Other outcomes:
Locations:
city: Shiraz
country: Iran, Islamic Republic of
facility: Shahid Motahhari Clinic, Shiraz University of Medical Sciences
state: Fars
Study officials:
affiliation: Endocrine and Metabolism Research Center, Shiraz University of Medical Sciences
name: Gholamhossein Ranjbar Omrani, MD
role: STUDY_CHAIR
affiliation: Shiraz Nephrology and Urology Research Center, Shiraz University of Medical Sciences
name: Jamshid Roozbeh, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Endocrine and Metabolism Research Center, Shiraz University of Medical Sciences
name: Azar Sattarinejad, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Endocrine and Metabolism Research Center, Shiraz University of Medical Sciences
name: Mesbah Shams, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.