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Effect of Administration of Resveratrol on Glycemic Variability in Individuals With Type 2 Diabetes Mellitus

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ClinicalTrials.gov Identifier: NCT02549924
Recruitment Status : Terminated (no financial support)
First Posted : September 15, 2015
Last Update Posted : May 8, 2018
Sponsor:
Information provided by (Responsible Party):
Esperanza Martínez-Abundis, University of Guadalajara

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.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Drug: Resveratrol Drug: Placebo Phase 2

Detailed Description:
The objective is to evaluate the effect of administration of resveratrol on GV in individuals with T2DM inadequately controlled on metformin, for which we will conduct a double-blind trial, randomized, placebo control group, each group 11 male and female patients 30-60 years of age with T2DM inadequately controlled with metformin [2000 mg / day and glycosylated hemoglobin A1c (A1C) ≥% 7], with body mass index [BMI] form 25.0 to 34.9 kg / m2. Randomization will determine who will receive the intervention during the 8-week trial [resveratrol capsules, 500 mg 3 times daily with the first bite of each meal or approved placebo capsules], both groups also continue with metformin. The clinical findings and laboratory tests include a metabolic profile and biosafety, which will be made at baseline and at 8 weeks. Body weight, body fat, BMI and blood pressure will be determined during the initial and final visit, likewise, plasma glucose concentrations every hour recorded over 72 hours by continuous monitoring system outpatient glucose [MACG] via iPro ™ 2 [Medtronic MiniMed, Northridge] system, through which the mean amplitude of glucose excursions [MAGE] is calculated and AUC glucose, which will serve to assess the GV. Adverse events and adherence to treatment will be documented. Statistical analysis: Mann-Whitney U test, Wilcoxon and Fisher exact test. It is considered with significance at p <0.05.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Effect of Administration of Resveratrol on Glycemic Variability in Individuals With Type 2 Diabetes Mellitus Inadequately Controlled With Metformin
Study Start Date : September 2016
Actual Primary Completion Date : January 1, 2018
Actual Study Completion Date : February 1, 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Resveratrol

Arm Intervention/treatment
Experimental: Resveratrol
Individuals with T2DM inadequately controlled with metformin 2000 mg/day and A1C ≥7%.
Drug: Resveratrol
Resveratrol capsules, 500 mg 3 times daily with the first bite of each meal
Other Name: Trans-resveratrol

Placebo Comparator: Placebo
Individuals with T2DM inadequately controlled with metformin 2000 mg/day and A1C ≥7%.
Drug: Placebo
Placebo capsules, 500 mg 3 times daily with the first bite of each meal
Other Name: Calcined Magnesia




Primary Outcome Measures :
  1. Area under the curve [ Time Frame: 56 days ]
    Before and after intervention with ambulatory continuous glucose monitoring during 72 h, oxidase glucose iPro ™ 2

  2. Mean amplitude of glucose excursions (MAGE) [ Time Frame: 56 days ]
    Before and after intervention with ambulatory continuous glucose monitoring during 72 h, oxidase glucose iPro ™ 2


Secondary Outcome Measures :
  1. Fasting plasma glucose [ Time Frame: 56 days ]
    Before and after intervention by spectrophotometry

  2. Postprandial glucose [ Time Frame: 56 days ]
    Before and after intervention with ambulatory continuous glucose monitoring during 72 h, oxidase glucose iPro ™ 2

  3. A1C [ Time Frame: 56 days ]
    Before and after intervention by high-performance liquid chromatography

  4. Total cholesterol [ Time Frame: 56 days ]
    Before and after intervention by spectrophotometry

  5. Triglycerides [ Time Frame: 56 days ]
    Before and after intervention by spectrophotometry

  6. High-density lipoprotein cholesterol [ Time Frame: 56 days ]
    Before and after intervention by spectrophotometry

  7. Low-density lipoprotein cholesterol [ Time Frame: 56 days ]
    Friedewald formula

  8. Very-low density lipoprotein [ Time Frame: 56 days ]
    Friedewald formula

  9. Alanine aminotransferase [ Time Frame: 56 days ]
    Before and after intervention by spectrophotometry

  10. Aspartate aminotransferase [ Time Frame: 56 days ]
    Before and after intervention by spectrophotometry

  11. Creatinine [ Time Frame: 56 days ]
    Before and after intervention by spectrophotometry

  12. Blood pressure [ Time Frame: 56 days ]
    Before and after intervention using a digital manometer

  13. Body and visceral fat % [ Time Frame: 56 days ]
    Before and after intervention using a impedance bascule, Tanita MR



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Ages Eligible for Study:   30 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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]

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02549924


Locations
Mexico
Institute of Experimental and Clinical Therapeutics (INTEC), CUCS, University of Guadalajara
Guadalajara, Jalisco, Mexico, 44340
Sponsors and Collaborators
University of Guadalajara
Investigators
Principal Investigator: Esperanza Martínez-Abundis, PhD Institute of Experimental and Clinical Therapeutics (INTEC), CUCS, University of Guadalajara

Responsible Party: Esperanza Martínez-Abundis, Esperanza Martínez-Abundis, FACP, PhD, University of Guadalajara
ClinicalTrials.gov Identifier: NCT02549924     History of Changes
Other Study ID Numbers: ERVGDM2
First Posted: September 15, 2015    Key Record Dates
Last Update Posted: May 8, 2018
Last Verified: May 2018

Keywords provided by Esperanza Martínez-Abundis, University of Guadalajara:
Resveratrol
Glycemic Variability
MAGE

Additional relevant MeSH terms:
Resveratrol
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anti-Inflammatory Agents
Antirheumatic Agents
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Enzyme Inhibitors
Platelet Aggregation Inhibitors
Antimutagenic Agents
Anticarcinogenic Agents