Type 2 Diabetes MellitusPhase 2NCT02549924
Effect of Administration of Resveratrol on Glycemic Variability in Individuals With Type 2 Diabetes Mellitus
A Phase 2 study testing Resveratrol in people with Type 2 Diabetes Mellitus, run by University of Guadalajara at 1 site in Mexico.
Trial 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 ]. Read more about this study
- Who is it for?
- Ages 30 to 60 years
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- Resveratrol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 22 participants
- Where
- 1 siteMexico
- Study dates
- Sep 2016to 1 Feb 2018
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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]
Trial locations and contacts
1 site in 1 country.
Mexico1 site
Institute of Experimental and Clinical Therapeutics (INTEC), CUCS, University of Guadalajara
Guadalajara, Jalisco, 44340
About this study
Official title: Effect of Administration of Resveratrol on Glycemic Variability in Individuals With Type 2 Diabetes Mellitus Inadequately Controlled With Metformin
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.
Read the 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.
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- Resveratrol, Placebo
- Keywords
- Resveratrol, Glycemic Variability, MAGE
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ResveratrolDrug
Also called Trans-resveratrol
Resveratrol capsules, 500 mg 3 times daily with the first bite of each meal
PlaceboDrug
Also called Calcined Magnesia
Placebo capsules, 500 mg 3 times daily with the first bite of each meal
| Study group | Role | What they receive |
|---|---|---|
| Resveratrol | Experimental | Individuals with T2DM inadequately controlled with metformin 2000 mg/day and A1C ≥7%. Receives: Drug: Resveratrol |
| Placebo | Placebo comparator | Individuals with T2DM inadequately controlled with metformin 2000 mg/day and A1C ≥7%. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the curve
Before and after intervention with ambulatory continuous glucose monitoring during 72 h, oxidase glucose iPro ™ 2
Measured: 56 days
Mean amplitude of glucose excursions (MAGE)
Before and after intervention with ambulatory continuous glucose monitoring during 72 h, oxidase glucose iPro ™ 2
Measured: 56 days
Secondary outcomes (13)
Fasting plasma glucose
Before and after intervention by spectrophotometry
Measured: 56 days
Postprandial glucose
Before and after intervention with ambulatory continuous glucose monitoring during 72 h, oxidase glucose iPro ™ 2
Measured: 56 days
A1C
Before and after intervention by high-performance liquid chromatography
Measured: 56 days
Total cholesterol
Before and after intervention by spectrophotometry
Measured: 56 days
Triglycerides
Before and after intervention by spectrophotometry
Measured: 56 days
High-density lipoprotein cholesterol
Before and after intervention by spectrophotometry
Measured: 56 days
Low-density lipoprotein cholesterol
Friedewald formula
Measured: 56 days
Very-low density lipoprotein
Friedewald formula
Measured: 56 days
Alanine aminotransferase
Before and after intervention by spectrophotometry
Measured: 56 days
Aspartate aminotransferase
Before and after intervention by spectrophotometry
Measured: 56 days
Creatinine
Before and after intervention by spectrophotometry
Measured: 56 days
Blood pressure
Before and after intervention using a digital manometer
Measured: 56 days
Body and visceral fat %
Before and after intervention using a impedance bascule, Tanita MR
Measured: 56 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2015 (estimated)
- Study startSep 2016
- Primary completion1 Jan 2018
- Study completion1 Feb 2018
Why it stopped: no financial support
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Guadalajara
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Esperanza Martínez-Abundis, University of Guadalajara
- Investigators
- Esperanza Martínez-Abundis, PhD, Principal investigator, Institute of Experimental and Clinical Therapeutics (INTEC), CUCS, University of Guadalajara
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02549924
- Sponsor's protocol ID
- ERVGDM2
- Status last verified
- May 2018
- First submitted
- 9 Sep 2015
- Last updated
- 8 May 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Administration of Resveratrol on Glycemic Variability in Individuals With Type 2 Diabetes Mellitus Inadequately Controlled With Metformin
- ClinicalTrials.gov ID
- NCT02549924
- Acronym / sponsor ID
- ERVGDM2
- Conditions
- Type 2 Diabetes Mellitus
- Keywords
- Resveratrol, Glycemic Variability, MAGE
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: no financial support
- Enrolment
- 22 participants (actual)
- Lead sponsor
- University of GuadalajaraUniversity, hospital or other
- Study start
- Sep 2016
- Primary completion
- 1 Jan 2018 (actual)
- Study completion
- 1 Feb 2018 (actual)
- First posted
- 15 Sep 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Resveratrol | Experimental | Drug: ResveratrolIndividuals with T2DM inadequately controlled with metformin 2000 mg/day and A1C ≥7%. |
| Placebo | Placebo comparator | Drug: PlaceboIndividuals with T2DM inadequately controlled with metformin 2000 mg/day and A1C ≥7%. |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ResveratrolAlso: Trans-resveratrolResveratrol capsules, 500 mg 3 times daily with the first bite of each meal | Drug | Resveratrol |
| PlaceboAlso: Calcined MagnesiaPlacebo capsules, 500 mg 3 times daily with the first bite of each meal | Drug | Placebo |
Primary outcome
Area under the curve
Time frame: 56 days
Before and after intervention with ambulatory continuous glucose monitoring during 72 h, oxidase glucose iPro ™ 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
13 secondary outcomes
Fasting plasma glucose
Time frame: 56 days
Postprandial glucose
Time frame: 56 days
A1C
Time frame: 56 days
Total cholesterol
Time frame: 56 days
Triglycerides
Time frame: 56 days
High-density lipoprotein cholesterol
Time frame: 56 days
Low-density lipoprotein cholesterol
Time frame: 56 days
Very-low density lipoprotein
Time frame: 56 days
Alanine aminotransferase
Time frame: 56 days
Aspartate aminotransferase
Time frame: 56 days
Creatinine
Time frame: 56 days
Blood pressure
Time frame: 56 days
Body and visceral fat %
Time frame: 56 days
Results and safety
The study was stopped early (reason given: no financial support). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Esperanza Martínez-Abundis, PhD principal investigator
Institute of Experimental and Clinical Therapeutics (INTEC), CUCS, University of Guadalajara
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Resveratrol in people with Type 2 Diabetes Mellitus, run by University of Guadalajara at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 8 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: no financial support). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area under the curve (time frame: 56 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2018.