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
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
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
NCT ID
NCT02704494
First Posted
March 4, 2016
Last Updated
October 3, 2017
Sponsor
Shiraz University of Medical Sciences
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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