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Resveratrol's Effects in Diabetic Nephropathy (ReDNeph)

Primary Purpose

Diabetic Nephropathy

Status
Completed
Phase
Early Phase 1
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
Resveratrol
Placebo
Losartan
Sponsored by
Shiraz University of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetic Nephropathy focused on measuring Resveratrol, Diabetes mellitus, Diabetes complications, Diabetic nephropathies, Proteinuria, Albuminuria, renal insufficiency

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Shahid Motahhari Clinic, Shiraz University of Medical Sciences

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Resveratrol

Placebo

Arm Description

Resveratrol + Losartan

Placebo + Losartan

Outcomes

Primary Outcome Measures

Urine albumin level
Serum creatinin

Secondary Outcome Measures

Fasting blood sugar (FBS)
Glycosylated hemoglobin (A1C)
Liver aminotransferases (ALT and AST)
Serum insulin level
Number of patients with adverse events

Full Information

First Posted
March 4, 2016
Last Updated
October 3, 2017
Sponsor
Shiraz University of Medical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT02704494
Brief Title
Resveratrol's Effects in Diabetic Nephropathy
Acronym
ReDNeph
Official Title
Resveratrol's Effects in Diabetic Nephropathy
Study Type
Interventional

2. Study Status

Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
March 2016 (Actual)
Primary Completion Date
February 2017 (Actual)
Study Completion Date
February 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shiraz University of Medical Sciences

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Nephropathy
Keywords
Resveratrol, Diabetes mellitus, Diabetes complications, Diabetic nephropathies, Proteinuria, Albuminuria, renal insufficiency

7. Study Design

Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Resveratrol
Arm Type
Experimental
Arm Description
Resveratrol + Losartan
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo + Losartan
Intervention Type
Drug
Intervention Name(s)
Resveratrol
Intervention Description
Resveratrol 500mg daily
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo 1 capsule daily
Intervention Type
Drug
Intervention Name(s)
Losartan
Intervention Description
Losartan 12.5mg daily
Primary Outcome Measure Information:
Title
Urine albumin level
Time Frame
3 months
Title
Serum creatinin
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Fasting blood sugar (FBS)
Time Frame
3 months
Title
Glycosylated hemoglobin (A1C)
Time Frame
3 months
Title
Liver aminotransferases (ALT and AST)
Time Frame
3 months
Title
Serum insulin level
Time Frame
3 months
Title
Number of patients with adverse events
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gholamhossein Ranjbar Omrani, MD
Organizational Affiliation
Endocrine and Metabolism Research Center, Shiraz University of Medical Sciences
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Jamshid Roozbeh, MD
Organizational Affiliation
Shiraz Nephrology and Urology Research Center, Shiraz University of Medical Sciences
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Azar Sattarinejad, MD
Organizational Affiliation
Endocrine and Metabolism Research Center, Shiraz University of Medical Sciences
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mesbah Shams, MD
Organizational Affiliation
Endocrine and Metabolism Research Center, Shiraz University of Medical Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shahid Motahhari Clinic, Shiraz University of Medical Sciences
City
Shiraz
State/Province
Fars
Country
Iran, Islamic Republic of

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
29983230
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.
Results Reference
derived

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Resveratrol's Effects in Diabetic Nephropathy

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