Gestational DiabetesPhase 4NCT01997762
Can Resveratrol Improve Insulin Sensitivity and Preserve Beta Cell Function Following Gestational Diabetes?
A Phase 4 study testing Resveratrol in people with Gestational Diabetes, run by University of Manitoba at 1 site in Canada.
Trial summary
The purpose of this study is to determine if resveratrol supplementation preserves beta cell function and insulin sensitivity in post-partum women following a first diagnosis of gestational diabetes. We hypothesize that daily supplementation with resveratrol will preserve beta cell function and insulin sensitivity. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Gestational Diabetes
- 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
- 112 participants
- Where
- 1 siteCanada
- Study dates
- May 2014to Dec 2016
- Phase
- Phase 4
- 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 18 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Adult women (18 years of age or older) 3 months post-partum with a recent history of first diagnosis of gestational diabetes.
- Willingness to provide informed consent 3 months post-partum.
Who cannot join
- Abnormal glucose tolerance or type 2 diabetes recorded at 3 months post-partum.
- Breastfeeding beyond 9 months post-partum.
- Intention to consume resveratrol open label.
- Intention to drink red wine (more than 4 glasses per week) or eat foods high in resveratrol (grapes, grape juice, peanuts, peanut products).
- Unwillingness to use two approved types of contraception until one year post-partum and unwillingness to undergo pregnancy test at randomization.
- Twin pregnancy.
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- Consuming medications with a risk of interaction with resveratrol.
- Liver disease.
- Unlikely to be able to comply with study follow-up as judged by social (e.g. transient, not permanent residents, etc.) or geographical considerations.
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Manitoba Institute of Child Health
Winnipeg, Manitoba, R3E 3P4
Shayne P Taback, MD
About this study
The purpose of this study is to determine if resveratrol supplementation preserves beta cell function and insulin sensitivity in post-partum women following a first diagnosis of gestational diabetes. We hypothesize that daily supplementation with resveratrol will preserve beta cell function and insulin sensitivity.
Read the detailed description
Our primary aim is to perform a randomized controlled trial of resveratrol for the improvement of insulin sensitivity and the preservation of beta cell function in post-partum women following a first diagnosis of gestational diabetes. Our long-term goal is to test resveratrol for the secondary prevention of gestational diabetes and type 2 diabetes. We have developed six conditions that should be satisfied by the study to justify project expansion. Therefore, we will be testing hypotheses and computing estimates for the following six outcomes: (1) recruitment numbers, (2) adherence to study treatment, (3) adherence to study visits, (4) insulin sensitivity measured at 12 months post-partum, (5) beta cell function measured at 12 months post-partum, and (6) adverse events.
The study is a single-site, parallel, double-blind, randomized, placebo-controlled trial. The study population consists of women recruited during pregnancy who had a confirmed first diagnosis of gestational diabetes, who do not have either diabetes or pre-diabetes when re-tested 3 months post-partum, and who have stopped breastfeeding by 9 months post-partum. They study intervention is resveratrol (or identical placebo) twice daily for a total of 12 weeks from 9 months to 12 months post-partum. Our planned sample size is 112 women based on the hypothesis testing and estimation considerations for the six above-mentioned outcomes.
- Conditions
- Gestational Diabetes
- Being tested
- Resveratrol, Placebo
- Keywords
- resveratrol,, gestational diabetes,, beta cell function, history
- Medical subject headings
- Diabetes, Gestational
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ResveratrolDietary supplement
Also called All Natural Resveratrol 98% Super Strength
gel-coated capsules to be taken twice a day; one with breakfast and dinner
PlaceboDietary supplement
Also called Corn starch capsules
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Corn starch capsules, 1 capsule twice a day for 3 months Receives: Dietary Supplement: Placebo |
| Resveratrol | Experimental | Resveratrol capsules, 250 mg twice a day for 3 months Receives: Dietary Supplement: Resveratrol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in beta cell function
Beta cell function will be assessed by calculating the Insulin Secretion Sensitivity Index-2, a ratio of the area under the curve (AUC) for glucose and the AUC for insulin after an oral glucose tolerance test.
Measured: baseline and 3 months after intervention
Secondary outcomes (3)
recruitment rates
Measured: recruitment rates will be followed throughout the recruitment phase, which is expected to take 2 years maximum
treatment adherence
Measured: 3 months after intervention
Change in insulin sensitivity
Insulin sensitivity will be assessed by calculating the homeostasis model of assessment of insulin resistance (HOMA-IR).
Measured: baseline and 3 months after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2013 (estimated)
- Study startMay 2014
- Primary completionDec 2015 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gestational DiabetesStudies 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 112 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Manitoba
- Sponsor type
- University, hospital or other
- Collaborators
- Manitoba Institute of Child Health
- Responsible party
- Sponsor
- Investigators
- Shayne P Taback, MD, Principal investigator, University of Manitoba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01997762
- Sponsor's protocol ID
- B2013:151
- Status last verified
- Nov 2013
- First submitted
- 13 Nov 2013
- Last updated
- 12 May 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can Resveratrol Improve Insulin Sensitivity and Preserve Beta Cell Function Following Gestational Diabetes?
- ClinicalTrials.gov ID
- NCT01997762
- Acronym / sponsor ID
- B2013:151
- Conditions
- Gestational Diabetes
- Keywords
- resveratrol,, gestational diabetes,, beta cell function, history
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 112 participants (estimated)
- Lead sponsor
- University of ManitobaUniversity, hospital or other
- Collaborators
- Manitoba Institute of Child Health
- Study start
- May 2014
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 28 Nov 2013 (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.
The purpose of this study is to determine if resveratrol supplementation preserves beta cell function and insulin sensitivity in post-partum women following a first diagnosis of gestational diabetes. We hypothesize that daily supplementation with resveratrol will preserve beta cell function and insulin sensitivity.
Detailed description
Our primary aim is to perform a randomized controlled trial of resveratrol for the improvement of insulin sensitivity and the preservation of beta cell function in post-partum women following a first diagnosis of gestational diabetes. Our long-term goal is to test resveratrol for the secondary prevention of gestational diabetes and type 2 diabetes. We have developed six conditions that should be satisfied by the study to justify project expansion. Therefore, we will be testing hypotheses and computing estimates for the following six outcomes: (1) recruitment numbers, (2) adherence to study treatment, (3) adherence to study visits, (4) insulin sensitivity measured at 12 months post-partum, (5) beta cell function measured at 12 months post-partum, and (6) adverse events.
The study is a single-site, parallel, double-blind, randomized, placebo-controlled trial. The study population consists of women recruited during pregnancy who had a confirmed first diagnosis of gestational diabetes, who do not have either diabetes or pre-diabetes when re-tested 3 months post-partum, and who have stopped breastfeeding by 9 months post-partum. They study intervention is resveratrol (or identical placebo) twice daily for a total of 12 weeks from 9 months to 12 months post-partum. Our planned sample size is 112 women based on the hypothesis testing and estimation considerations for the six above-mentioned outcomes.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Dietary Supplement: PlaceboCorn starch capsules, 1 capsule twice a day for 3 months |
| Resveratrol | Experimental | Dietary Supplement: ResveratrolResveratrol capsules, 250 mg twice a day for 3 months |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Adult women (18 years of age or older) 3 months post-partum with a recent history of first diagnosis of gestational diabetes.
- Willingness to provide informed consent 3 months post-partum.
Key exclusion criteria (9 listed)
- Abnormal glucose tolerance or type 2 diabetes recorded at 3 months post-partum.
- Breastfeeding beyond 9 months post-partum.
- Intention to consume resveratrol open label.
- Intention to drink red wine (more than 4 glasses per week) or eat foods high in resveratrol (grapes, grape juice, peanuts, peanut products).
- Unwillingness to use two approved types of contraception until one year post-partum and unwillingness to undergo pregnancy test at randomization.
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: All Natural Resveratrol 98% Super Strengthgel-coated capsules to be taken twice a day; one with breakfast and dinner | Dietary supplement | Resveratrol |
| PlaceboAlso: Corn starch capsules | Dietary supplement | Placebo |
Primary outcome
Change in beta cell function
Time frame: baseline and 3 months after intervention
Beta cell function will be assessed by calculating the Insulin Secretion Sensitivity Index-2, a ratio of the area under the curve (AUC) for glucose and the AUC for insulin after an oral glucose tolerance test.
3 secondary outcomes
recruitment rates
Time frame: recruitment rates will be followed throughout the recruitment phase, which is expected to take 2 years maximum
treatment adherence
Time frame: 3 months after intervention
Change in insulin sensitivity
Time frame: baseline and 3 months after intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2014.
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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.
Shayne P Taback, MD principal investigator
University of Manitoba
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Resveratrol in people with Gestational Diabetes, run by University of Manitoba at 1 site in Canada.
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 2 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 12 May 2014. 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 Canada. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Danielle M Stringer, PhD ((204) 789-3273, dstringer@mich.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in beta cell function (time frame: baseline and 3 months after intervention). 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 12 May 2014.