NCT02244879

Brief Summary

This research will investigate the effect of resveratrol on inflammatory mediators in type 2 diabetic patients in vivo. The investigators will also investigate the hypothesis that resveratrol has an antioxidant activity, improves insulin sensitivity and lipid pattern, down-regulates bone-turnover.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
192

participants targeted

Target at below P25 for phase_3 type-2-diabetes-mellitus

Timeline
Completed

Started Oct 2013

Typical duration for phase_3 type-2-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

October 1, 2013

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

September 15, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 19, 2014

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2016

Completed
Last Updated

March 8, 2016

Status Verified

March 1, 2016

Enrollment Period

2.3 years

First QC Date

September 15, 2014

Last Update Submit

March 6, 2016

Conditions

Type 2 Diabetes MellitusInflammationInsulin ResistanceOther Disorders of Bone Density and Structure

Keywords

resveratroltype 2 diabetes mellitusinflammationinsulin resistancebody compositionbone mass

Outcome Measures

Primary Outcomes (1)

  • C reactive protein (CRP)

    To investigate changes from baseline in blood concentrations of high-sensitivity CRP after six months of treatment with either resveratrol at different dosages or placebo

    up to 25 months

Secondary Outcomes (1)

  • Metabolic and oxidative markers

    up to 25 months

Other Outcomes (1)

  • body composition and bone mineral density

    up to 25 months

Study Arms (3)

placebo

PLACEBO COMPARATOR

In this arm, 64 patients will receive a tablet of placebo once/day for 6 months

Dietary Supplement: resveratrol

resveratrol 40

EXPERIMENTAL

In this arm, 64 patients will receive a tablet of 40mg resveratrol once/day for 6 months

Dietary Supplement: resveratrol

resveratrol 500

EXPERIMENTAL

In this arm, 64 patients will receive a tablet of 500 mg resveratrol once/day for 6 months

Dietary Supplement: resveratrol

Interventions

resveratrolDIETARY_SUPPLEMENT

arm resveratrol 500: 6 months of resveratrol 500 mg/day arm resveratrol 40: 6 months of resveratrol 40 mg/day

placeboresveratrol 40resveratrol 500

Eligibility Criteria

Age35 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years of age and older
  • Type 2 diabetes with body mass index (BMI)\<35 kg/m2
  • Subjects on hypoglycemic agents other than insulin
  • Willing to give written informed consent and able to understand, to participate in and to comply with the study requirements.

You may not qualify if:

  • Subjects on any antioxidant medication
  • Patient on non-steroidal anti-inflammatory drug, steroids or insulin
  • On any agent with significant antioxidant properties
  • History of drug or alcohol abuse
  • Liver or kidney diseases
  • Any life threatening diseases
  • Allergy to peanuts, grapes, wine, mulberries
  • Pregnant women
  • Coronary event or procedure (myocardial infarction, unstable angina, coronary artery bypass surgery or coronary angioplasty) in the previous four Weeks
  • Subjects on anticoagulants

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Turin

Turin, IT, 10126, Italy

Location

Related Publications (2)

  • Bo S, Togliatto G, Gambino R, Ponzo V, Lombardo G, Rosato R, Cassader M, Brizzi MF. Impact of sirtuin-1 expression on H3K56 acetylation and oxidative stress: a double-blind randomized controlled trial with resveratrol supplementation. Acta Diabetol. 2018 Apr;55(4):331-340. doi: 10.1007/s00592-017-1097-4. Epub 2018 Jan 12.

    PMID: 29330620DERIVED

  • Bo S, Ponzo V, Evangelista A, Ciccone G, Goitre I, Saba F, Procopio M, Cassader M, Gambino R. Effects of 6 months of resveratrol versus placebo on pentraxin 3 in patients with type 2 diabetes mellitus: a double-blind randomized controlled trial. Acta Diabetol. 2017 May;54(5):499-507. doi: 10.1007/s00592-017-0977-y. Epub 2017 Feb 25.

    PMID: 28238190DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2InflammationInsulin Resistance

Interventions

Resveratrol

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsHyperinsulinism

Intervention Hierarchy (Ancestors)

StilbestrolsStilbenesBenzylidene CompoundsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolyphenolsPhenols

Study Officials

  • Simona Bo, MD

    University of Turin, Italy

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

September 15, 2014

First Posted

September 19, 2014

Study Start

October 1, 2013

Primary Completion

February 1, 2016

Study Completion

February 1, 2016

Last Updated

March 8, 2016

Record last verified: 2016-03

Locations

IT(1)