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| Name | Class |
|---|---|
| Manitoba Institute of Child Health | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Corn starch capsules, 1 capsule twice a day for 3 months |
|
| Resveratrol | Experimental | Resveratrol capsules, 250 mg twice a day for 3 months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Resveratrol | Dietary Supplement | gel-coated capsules to be taken twice a day; one with breakfast and dinner |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | baseline and 3 months after intervention |
| Measure | Description | Time Frame |
|---|---|---|
| recruitment rates | recruitment rates will be followed throughout the recruitment phase, which is expected to take 2 years maximum | |
| treatment adherence | 3 months after intervention | |
| Measure | Description | Time Frame |
|---|---|---|
| change in liver function | liver function will be assessed by measuring plasma concentrations of alanine aminotransferase, aspartate aminotransferase, gamma glutamyltransferase, total bilirubin and conjugated bilirubin. | baseline and 3 months after intervention |
| change in C-reactive protein |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Danielle M Stringer, PhD | Contact | (204) 789-3273 | dstringer@mich.ca |
| Name | Affiliation | Role |
|---|---|---|
| Shayne P Taback, MD | University of Manitoba | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Manitoba Institute of Child Health | Recruiting | Winnipeg | Manitoba | R3E 3P4 | Canada |
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| ID | Term |
|---|---|
| D016640 | Diabetes, Gestational |
| ID | Term |
|---|---|
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D003920 | Diabetes Mellitus |
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| ID | Term |
|---|---|
| D000077185 | Resveratrol |
| D013213 | Starch |
| ID | Term |
|---|---|
| D000081225 | Stilbestrols |
| D013267 | Stilbenes |
| D001597 | Benzylidene Compounds |
| D001555 | Benzene Derivatives |
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| Placebo | Dietary Supplement |
|
|
| Change in insulin sensitivity |
Insulin sensitivity will be assessed by calculating the homeostasis model of assessment of insulin resistance (HOMA-IR). |
| baseline and 3 months after intervention |
| baseline and 3 months after intervention |
| change in glycated hemoglobin | baseline and 3 months after intervention |
| change in serum lipids | baseline and 3 months after intervention |
| change in plasma levels of resveratrol and resveratrol metabolites | baseline and 3 months after intervention |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D006841 |
| Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D059808 | Polyphenols |
| D010636 | Phenols |
| D005936 | Glucans |
| D001704 | Biopolymers |
| D011108 | Polymers |
| D046911 | Macromolecular Substances |
| D004040 | Dietary Carbohydrates |
| D002241 | Carbohydrates |
| D011134 | Polysaccharides |