Protocol summary

Summary
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.

General information

Acronym
ReDNeph
IRCT registration information
IRCT registration number: IRCT2016100716876N2
Registration date: 2016-11-25, 1395/09/05
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2016-11-25, 1395/09/05
Registrant information
Name
Mesbah Shams
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 3647 4316
Email address
shams@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor of Research, Shiraz University of Medical Sciences
Expected recruitment start date
2016-04-19, 1395/01/31
Expected recruitment end date
2017-01-19, 1395/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Resveratrol's Effects in Diabetic Nephropathy
Public title
Resveratrol's Effects in Diabetic Nephropathy
Purpose
Treatment
Inclusion/Exclusion 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
Age
From 18 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

1

Registry name
Resveratrol's Effects in Diabetic Nephropathy ( ReDNeph )
Secondary trial Id
ClinicalTrials.gov ID: NCT02704494
Registration date
2016-03-10, 1394/12/20

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee, Shiraz University of Medical Sciences
Street address
Shiraz University of Medical Sciences, Zand St.
City
Shiraz
Postal code
Approval date
2015-08-02, 1394/05/11
Ethics committee reference number
IR.SUMS.REC.1394.81

Health conditions studied

1

Description of health condition studied
diabetes mellitus
ICD-10 code
E11-NO8.3
ICD-10 code description
Non-insulin-dependent diabetes mellitus-diabetic nephropathy

Primary outcomes

1

Description
Urine albumin level
Timepoint
before intervention and 3 months after intervention
Method of measurement
miligram per deciliter with immunoturbidometry method

2

Description
Serum creatinin
Timepoint
before intervention and 3months after intervention
Method of measurement
miligram per deciliter

Secondary outcomes

1

Description
Fasting blood sugar (FBS)
Timepoint
before intervention and 3 months after intervention
Method of measurement
miligram per deciliter with colorimetry method

2

Description
Glycosylated hemoglobin (A1C)
Timepoint
before intervention and 3 months after intervention
Method of measurement
enzymatic method

3

Description
Liver aminotransferases (ALT)
Timepoint
before intervention and 3 months after intervention
Method of measurement
colorimetric method

4

Description
Serum insulin level
Timepoint
before intervention and 3 months after intervention
Method of measurement
IRMA

5

Description
Number of patients with adverse events
Timepoint
3 months after initiation of intervention
Method of measurement
questionnair

6

Description
serum level of aspartate aminotransferase(AST)
Timepoint
before intervention and 3 months after intervention
Method of measurement
colorimetric method

7

Description
serum levels of gamma glutamyl transpeptidase(GGT)
Timepoint
before intervention and 3 months after intervention
Method of measurement
colorimetric method

8

Description
serum triglyceride
Timepoint
before intervention and 3 months after intervention
Method of measurement
colorimetric method

9

Description
serum cholesterol
Timepoint
before intervention and 3 months after intervention
Method of measurement
colorimetric method

10

Description
serum HDL(high density lipoprotein)
Timepoint
before intervention and 3 months after intervention
Method of measurement
colorimetric method

11

Description
serum LDL(low density lipoprotein)
Timepoint
before intervention and 3 months after intervention
Method of measurement
colorimetric method

12

Description
serum level of alkaline phosphatase
Timepoint
before intervention and 3 months after intervention
Method of measurement
colorimetric method

Intervention groups

1

Description
Intervention group: Resveratrol+ Losartan Resveratrol:500 mg capsule; 1 capsule daily for 3 months Losartan:25 mg tablet; 1/2 tablet daily for 3 months
Category
Treatment - Drugs

2

Description
Control group:Placebo+ LosartanPlacebo: Carbo methyl cellulose(CMC) 500 mg capsules; 1 capsule daily for 3 monthsLosartan:25mg tablet; 1/2 tablet daily for 3 months
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahid Mottahari Clinic
Full name of responsible person
Azar Sattarinezhad
Street address
Nemazee Square
City
Shiraz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research,shiraz university of medical sciences
Full name of responsible person
S. Basir Hashemi, M.D.
Street address
Shiraz university of medical sciences, Zand avenue, Seventh floor
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research,shiraz university of medical sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Internal Medicine Department, Shiraz University of Medical Sciences
Full name of responsible person
Azar Sattarinezhad
Position
Endocrine fellowship
Other areas of specialty/work
Street address
Internal Medicine Depatment, Nemazee Hospital
City
Shiraz
Postal code
Phone
+98 71 3647 4316
Fax
+98 71 3647 4316
Email
sataria@sums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Mesbah Shams
Position
Associate professor of Internal Medicine and Endocrinology
Other areas of specialty/work
Street address
Internal Medicine Department, Nemazee Hospital, Zand avenue
City
Shiraz
Postal code
71937-11351
Phone
+98 71 3647 4316
Fax
Email
shams@sums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Mesbah Shams
Position
Associate professor of Internal Medicine and Endocrinology
Other areas of specialty/work
Street address
Internal Medicine Department, Nemazee Hospital
City
Shiraz
Postal code
Phone
+98 71 3647 4316
Fax
Email
shams@sums.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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