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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Resveratrol | Experimental | Individuals with T2DM inadequately controlled with metformin 2000 mg/day and A1C ≥7%. |
|
| Placebo | Placebo Comparator | Individuals with T2DM inadequately controlled with metformin 2000 mg/day and A1C ≥7%. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Resveratrol | Drug | Resveratrol capsules, 500 mg 3 times daily with the first bite of each meal |
|
| Measure | Description | Time Frame |
|---|---|---|
| Area under the curve | Before and after intervention with ambulatory continuous glucose monitoring during 72 h, oxidase glucose iPro â„¢ 2 | 56 days |
| Mean amplitude of glucose excursions (MAGE) | Before and after intervention with ambulatory continuous glucose monitoring during 72 h, oxidase glucose iPro â„¢ 2 | 56 days |
| Measure | Description | Time Frame |
|---|---|---|
| Fasting plasma glucose | Before and after intervention by spectrophotometry | 56 days |
| Postprandial glucose | Before and after intervention with ambulatory continuous glucose monitoring during 72 h, oxidase glucose iPro â„¢ 2 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Esperanza MartÃnez-Abundis, PhD | Institute of Experimental and Clinical Therapeutics (INTEC), CUCS, University of Guadalajara | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute of Experimental and Clinical Therapeutics (INTEC), CUCS, University of Guadalajara | Guadalajara | Jalisco | 44340 | Mexico |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D000077185 | Resveratrol |
| ID | Term |
|---|---|
| D000081225 | Stilbestrols |
| D013267 | Stilbenes |
| D001597 | Benzylidene Compounds |
| D001555 | Benzene Derivatives |
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| Placebo | Drug | Placebo capsules, 500 mg 3 times daily with the first bite of each meal |
|
|
| 56 days |
| A1C | Before and after intervention by high-performance liquid chromatography | 56 days |
| Total cholesterol | Before and after intervention by spectrophotometry | 56 days |
| Triglycerides | Before and after intervention by spectrophotometry | 56 days |
| High-density lipoprotein cholesterol | Before and after intervention by spectrophotometry | 56 days |
| Low-density lipoprotein cholesterol | Friedewald formula | 56 days |
| Very-low density lipoprotein | Friedewald formula | 56 days |
| Alanine aminotransferase | Before and after intervention by spectrophotometry | 56 days |
| Aspartate aminotransferase | Before and after intervention by spectrophotometry | 56 days |
| Creatinine | Before and after intervention by spectrophotometry | 56 days |
| Blood pressure | Before and after intervention using a digital manometer | 56 days |
| Body and visceral fat % | Before and after intervention using a impedance bascule, Tanita MR | 56 days |
| D004700 | Endocrine System Diseases |
| D006841 |
| Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D059808 | Polyphenols |
| D010636 | Phenols |