NCT02549924.

Trial name or title	Acronym: —
Methods	Type of trial: safety/efficacy trial Allocation: randomised Intervention model: parallel assignment Masking: double‐blinded (participant, investigator) Primary purpose: treatment
Participants	Condition: type 2 diabetes mellitus Enrolment: estimated 22 Inclusion criteria BMI 25.0 to 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 mmHg systolic and ≥ 90 mmHg diastolic) Consumption of oral agents or other medications or supplements, unlike metformin, with proven properties that modify the behaviour 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)
Interventions	Intervention(s): resveratrol (500 mg 3 times daily) Comparator(s): placebo
Outcomes	Primary outcome(s): area under the curve, mean amplitude of glucose excursions (MAGE) Secondary outcome(s): fasting plasma glucose, postprandial glucose, A1C, total cholesterol, triglycerides, high‐density lipoprotein cholesterol, low‐density lipoprotein cholesterol, very low‐density lipoprotein, alanine aminotransferase, aspartate aminotransferase, creatinine, blood pressure, body and visceral fat % Other outcome(s): —
Starting date	Trial start date: September 2015 Trial completion date: February 2018
Contact information	Responsible party/principal investigator: Esperanza Martínez‐Abundis, PhD, Institute of Experimental and Clinical Therapeutics (INTEC), CUCS, University of Guadalajara (esperanzamartnezabundi@yahoo.com)
Study identifier	Trial identifier:NCT02549924
Official title	Effect of administration of resveratrol on glycemic variability in individuals with type 2 diabetes mellitus inadequately controlled with metformin
Stated purpose of study	Quote: "to know the effect of resveratrol on the glycemic variability [GV] in patients with T2DM who are not in control with metformin monotherapy based"
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