NCT02549924

Brief Summary

Type 2 diabetes mellitus \[ T2DM \] has quickly become the epidemic of the XXI century and challenging global health . Estimates of the World Health Organization \[ WHO \] indicate that globally , from 1995 to date has nearly tripled the number of people living with diabetes mellitus \[DM \]. Resveratrol has been extensively studied as a regulator of glucose through its antioxidant effects and protecting pancreatic β cells by activation of sirtuin -1 \[ SIRT1 \] dependent deacetylase nicotinamide adenine diphosphate \[ NAD \]. Therefore, it is important to know the effect of resveratrol on the glycemic variability \[GV \] in patients with T2DM who are not in control with metformin monotherapy based.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
22

participants targeted

Target at below P25 for phase_2 type-2-diabetes-mellitus

Timeline
Completed

Started Sep 2016

Typical duration for phase_2 type-2-diabetes-mellitus

Geographic Reach
1 country

1 active site

Status
terminated

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 9, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 15, 2015

Completed
12 months until next milestone

Study Start

First participant enrolled

September 1, 2016

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2018

Completed
Last Updated

May 8, 2018

Status Verified

May 1, 2018

Enrollment Period

1.3 years

First QC Date

September 9, 2015

Last Update Submit

May 2, 2018

Conditions

Type 2 Diabetes Mellitus

Keywords

ResveratrolGlycemic VariabilityMAGE

Outcome Measures

Primary Outcomes (2)

  • Area under the curve

    Before and after intervention with ambulatory continuous glucose monitoring during 72 h, oxidase glucose iPro ™ 2

    56 days

  • Mean amplitude of glucose excursions (MAGE)

    Before and after intervention with ambulatory continuous glucose monitoring during 72 h, oxidase glucose iPro ™ 2

    56 days

Secondary Outcomes (13)

  • Fasting plasma glucose

    56 days

  • Postprandial glucose

    56 days

  • A1C

    56 days

  • Total cholesterol

    56 days

  • Triglycerides

    56 days

  • +8 more secondary outcomes

Study Arms (2)

Resveratrol

EXPERIMENTAL

Individuals with T2DM inadequately controlled with metformin 2000 mg/day and A1C ≥7%.

Drug: Resveratrol

Placebo

PLACEBO COMPARATOR

Individuals with T2DM inadequately controlled with metformin 2000 mg/day and A1C ≥7%.

Drug: Placebo

Interventions

ResveratrolDRUG

Resveratrol capsules, 500 mg 3 times daily with the first bite of each meal

Also known as: Trans-resveratrol
Resveratrol
PlaceboDRUG

Placebo capsules, 500 mg 3 times daily with the first bite of each meal

Also known as: Calcined Magnesia
Placebo

Eligibility Criteria

Age30 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • BMI from 25.0-34.9 kg/m2
  • Diagnosis of T2DM
  • Fasting plasma glucose \>130 and \<250 mg/dl at the time of scrutiny
  • A1C between 7 and 10%
  • Metformin monotherapy
  • Written informed consent

You may not qualify if:

  • Women pregnant or breastfeeding
  • Untreated thyroid disease and/or uncontrolled hypertension \[≥150 systolic and diastolic ≥90\]
  • Consumption of oral agents or other medications or supplements, unlike metformin, with proven properties that modify the behavior of glucose
  • Total cholesterol \>400 mg/dL
  • Triglycerides ≥400 mg/dL
  • Liver enzymes \[ALT and AST\] more than twice the normal range
  • Glomerular filtration rate \<60 mL/min \[Cockcroft-Gault\]

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute of Experimental and Clinical Therapeutics (INTEC), CUCS, University of Guadalajara

Guadalajara, Jalisco, 44340, Mexico

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Resveratrol

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

StilbestrolsStilbenesBenzylidene CompoundsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolyphenolsPhenols

Study Officials

  • Esperanza Martínez-Abundis, PhD

    Institute of Experimental and Clinical Therapeutics (INTEC), CUCS, University of Guadalajara

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Esperanza Martínez-Abundis, FACP, PhD

Study Record Dates

First Submitted

September 9, 2015

First Posted

September 15, 2015

Study Start

September 1, 2016

Primary Completion

January 1, 2018

Study Completion

February 1, 2018

Last Updated

May 8, 2018

Record last verified: 2018-05

Locations

ME(1)