NCT02704494

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P75+ for early_phase_1

Timeline
Completed

Started Mar 2016

Shorter than P25 for early_phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2016

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

March 4, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 10, 2016

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2017

Completed
Last Updated

October 5, 2017

Status Verified

October 1, 2017

Enrollment Period

11 months

First QC Date

March 4, 2016

Last Update Submit

October 3, 2017

Conditions

Diabetic Nephropathy

Keywords

ResveratrolDiabetes mellitusDiabetes complicationsDiabetic nephropathiesProteinuriaAlbuminuriarenal insufficiency

Outcome Measures

Primary Outcomes (2)

  • Urine albumin level

    3 months

  • Serum creatinin

    3 months

Secondary Outcomes (5)

  • Fasting blood sugar (FBS)

    3 months

  • Glycosylated hemoglobin (A1C)

    3 months

  • Liver aminotransferases (ALT and AST)

    3 months

  • Serum insulin level

    3 months

  • Number of patients with adverse events

    3 months

Study Arms (2)

Resveratrol

EXPERIMENTAL

Resveratrol + Losartan

Drug: ResveratrolDrug: Losartan

Placebo

PLACEBO COMPARATOR

Placebo + Losartan

Drug: PlaceboDrug: Losartan

Interventions

ResveratrolDRUG

Resveratrol 500mg daily

Resveratrol
PlaceboDRUG

Placebo 1 capsule daily

Placebo
LosartanDRUG

Losartan 12.5mg daily

PlaceboResveratrol

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shahid Motahhari Clinic, Shiraz University of Medical Sciences

Shiraz, Fars, Iran

Location

Related Publications (2)

  • Colombijn JM, Hooft L, Jun M, Webster AC, Bots ML, Verhaar MC, Vernooij RW. Antioxidants for adults with chronic kidney disease. Cochrane Database Syst Rev. 2023 Nov 2;11(11):CD008176. doi: 10.1002/14651858.CD008176.pub3.

    PMID: 37916745DERIVED

  • 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.

    PMID: 29983230DERIVED

MeSH Terms

Conditions

Diabetic NephropathiesDiabetes MellitusDiabetes ComplicationsProteinuriaAlbuminuriaRenal Insufficiency

Interventions

ResveratrolLosartan

Condition Hierarchy (Ancestors)

Kidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesEndocrine System DiseasesGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesUrination DisordersUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

StilbestrolsStilbenesBenzylidene CompoundsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolyphenolsPhenolsBiphenyl CompoundsImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsTetrazoles

Study Officials

  • Gholamhossein Ranjbar Omrani, MD

    Endocrine and Metabolism Research Center, Shiraz University of Medical Sciences

    STUDY CHAIR

  • Jamshid Roozbeh, MD

    Shiraz Nephrology and Urology Research Center, Shiraz University of Medical Sciences

    PRINCIPAL INVESTIGATOR

  • Azar Sattarinejad, MD

    Endocrine and Metabolism Research Center, Shiraz University of Medical Sciences

    PRINCIPAL INVESTIGATOR

  • Mesbah Shams, MD

    Endocrine and Metabolism Research Center, Shiraz University of Medical Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor of internal medicine and endocrinology

Study Record Dates

First Submitted

March 4, 2016

First Posted

March 10, 2016

Study Start

March 1, 2016

Primary Completion

February 1, 2017

Study Completion

February 1, 2017

Last Updated

October 5, 2017

Record last verified: 2017-10

Locations

IR(1)