Manuel González-Ortiz1, Miriam Méndez-Del Villar2, Esperanza Martínez-Abundis2, Alejandra M Ramírez-Rodríguez2. 1. Department of Physiology, Institute of Experimental and Clinical Therapeutics, Health Science University Center, University of Guadalajara, Guadalajara, Mexico - uiec@prodigy.net.mx. 2. Department of Physiology, Institute of Experimental and Clinical Therapeutics, Health Science University Center, University of Guadalajara, Guadalajara, Mexico.
Abstract
BACKGROUND: The aim of this paper was to evaluate the effect of dapagliflozin on metabolic syndrome (MetS), insulin sensitivity and insulin secretion. METHODS: A randomized, double blind, placebo-controlled clinical trial was carried out in 24 patients with MetS. Glucose and insulin levels were measured every 30 minutes for 2 hours after a 75-g dextrose load. Metabolic profile was also evaluated before and after the pharmacological intervention. Twelve patients received dapagliflozin (10 mg) before breakfast for 90 days. The remaining 12 patients received placebo. Area under the curve (AUC) of glucose and insulin, total insulin secretion, first-phase of insulin secretion and insulin sensitivity were calculated. Data were tested using the Wilcoxon signed-rank, Mann-Whitney U and χ2 tests. The Ethics Committee approved the study protocol. RESULTS: After dapagliflozin, there were significant decreases in body weight (82.8±12.9 vs. 81.2±12.9 kg, P<0.001), BMI (33.4±3.6 vs. 32.7±3.7 kg/m2, P<0.001), waist circumference (102±10 vs. 98±9 cm, P<0.001), total cholesterol (5.4±0.7 vs. 5.2±0.7 mmol/L, P=0.049), triglycerides (2.7±1.4 vs. 1.7±0.8 mmol/L, P=0.003), AUC of insulin (103,914±55,170 vs. 45,018±22,146 pmol/L, P<0.001) and total insulin secretion (0.84±0.64 vs. 0.35±0.11, P<0.001). Seven patients (58.3%) in the dapagliflozin group showed remission of MetS (P=0.027). CONCLUSIONS:Dapagliflozin decreased body weight, BMI, waist circumference, total cholesterol, triglycerides, AUC of insulin and total insulin secretion, with a remission of MetS in 58.3%.
RCT Entities:
BACKGROUND: The aim of this paper was to evaluate the effect of dapagliflozin on metabolic syndrome (MetS), insulin sensitivity and insulin secretion. METHODS: A randomized, double blind, placebo-controlled clinical trial was carried out in 24 patients with MetS. Glucose and insulin levels were measured every 30 minutes for 2 hours after a 75-g dextrose load. Metabolic profile was also evaluated before and after the pharmacological intervention. Twelve patients received dapagliflozin (10 mg) before breakfast for 90 days. The remaining 12 patients received placebo. Area under the curve (AUC) of glucose and insulin, total insulin secretion, first-phase of insulin secretion and insulin sensitivity were calculated. Data were tested using the Wilcoxon signed-rank, Mann-Whitney U and χ2 tests. The Ethics Committee approved the study protocol. RESULTS: After dapagliflozin, there were significant decreases in body weight (82.8±12.9 vs. 81.2±12.9 kg, P<0.001), BMI (33.4±3.6 vs. 32.7±3.7 kg/m2, P<0.001), waist circumference (102±10 vs. 98±9 cm, P<0.001), total cholesterol (5.4±0.7 vs. 5.2±0.7 mmol/L, P=0.049), triglycerides (2.7±1.4 vs. 1.7±0.8 mmol/L, P=0.003), AUC of insulin (103,914±55,170 vs. 45,018±22,146 pmol/L, P<0.001) and total insulin secretion (0.84±0.64 vs. 0.35±0.11, P<0.001). Seven patients (58.3%) in the dapagliflozin group showed remission of MetS (P=0.027). CONCLUSIONS:Dapagliflozin decreased body weight, BMI, waist circumference, total cholesterol, triglycerides, AUC of insulin and total insulin secretion, with a remission of MetS in 58.3%.