NCT01881347

Brief Summary

The present study is designed to test the hypothesis that resveratrol supplementation will improve the function of the endothelium in patients with type 2 diabetes mellitus. The function of the endothelium will be tested with a non-invasive technique that uses ultrasound to measure the amount of dilation that occurs in the brachial artery following 5-minute cuff occlusion. To help us understand potential mechanisms of benefit, we will also collect blood, urine, and cell samples and test the effects of treatment on protein expression, nitric oxide production, and function of mitochondria.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
54

participants targeted

Target at P25-P50 for not_applicable diabetes-mellitus

Timeline
Completed

Started Jan 2013

Longer than P75 for not_applicable diabetes-mellitus

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

January 1, 2013

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

June 14, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 19, 2013

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
Last Updated

March 1, 2018

Status Verified

February 1, 2018

Enrollment Period

2.2 years

First QC Date

June 14, 2013

Last Update Submit

February 27, 2018

Conditions

Diabetes Mellitus

Keywords

endotheliummitochondriareactive oxygen speciesvascular biologyarterial stiffnessnitric oxide

Outcome Measures

Primary Outcomes (1)

  • Change from baseline in Brachial artery flow mediated dilation

    2 hours, 2 weeks, and 4 weeks

Secondary Outcomes (3)

  • Change from Baseline in Fingertip peripheral arterial tonometry

    2 hours, 2 weeks, and 4 weeks

  • Change from Baseline in Carotid femoral pulse wave velocity

    4 weeks

  • Change from Baseline in Reactive hyperemia

    2 hours, 2 weeks, 4 weeks

Other Outcomes (7)

  • Change from Baseline in Serum glucose

    2 and 4 weeks

  • Change from Baseline in Serum insulin

    2 and 4 weeks

  • Change from Baseline in Mononuclear cell mitochondrial DNA damage

    4 weejs

  • +4 more other outcomes

Study Arms (2)

Active First

EXPERIMENTAL

Active resveratrol first, placebo second

Dietary Supplement: ResveratrolDietary Supplement: Placebo

Placebo first

EXPERIMENTAL

Placebo first, active resveratrol second

Dietary Supplement: ResveratrolDietary Supplement: Placebo

Interventions

ResveratrolDIETARY_SUPPLEMENT

Resveratrol 100 mg daily for 2 weeks followed by resveratrol 300 mg daily for 2 weeks.

Active FirstPlacebo first
PlaceboDIETARY_SUPPLEMENT

Placebo 100 mg daily for 2 weeks followed by placebo 300 mg daily for 2 weeks.

Active FirstPlacebo first

Eligibility Criteria

Age21 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male and female subjects
  • Age over 21 years old
  • Body mass index less than 38 kg/m2
  • Clinical stable type 2 diabetes mellitus

You may not qualify if:

  • Women who are lactating or pregnant
  • Treatment with an investigations product within 30 days of screening
  • Clinically evident major illness of other organ systems, including cancer, renal failure, or other conditions in the opinion of the investigators that would make clinical study inappropriate
  • Liver transaminase levels greater than 3 times the upper limit of normal
  • History of psychological illness or condition that would interfere with the subject's ability to understand the requirements of the study
  • Vitamin supplements exceeding two times the recommended daily allowance
  • Resveratrol or other dietary supplements except for a daily multivitamin

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Boston University Medical Center

Boston, Massachusetts, 02118, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

Resveratrol

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

StilbestrolsStilbenesBenzylidene CompoundsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolyphenolsPhenols

Study Officials

  • Naomi Hamburg, MD

    Boston University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 14, 2013

First Posted

June 19, 2013

Study Start

January 1, 2013

Primary Completion

March 1, 2015

Study Completion

July 1, 2016

Last Updated

March 1, 2018

Record last verified: 2018-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)