NCT02113241

Effect of Dapagliflozin Administration on Metabolic Syndrome, Insulin Sensitivity, and Insulin Secretion

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: University of Guadalajara · Academic / Other
• Sex: All
• Age: 30 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

The Metabolic Syndrome is a high prevalence disease worldwide. About a quarter of the adult population suffers the disease. Dapagliflozin is an inhibitor of the sodium-glucose co-transporter SGLT2 in the kidney and is a novel treatment for diabetes type 2. Some studies indicate that SGLT2 inhibitors have benefits on blood pressure, triglycerides levels and help to raise the levels of high density lipoproteins cholesterol (c-HDL). The aim of this study is to evaluate the effect of dapagliflozin on metabolic syndrome, insulin sensitivity and insulin secretion. The investigators hypothesis is that the administration of dapagliflozin modifies the metabolic syndrome, insulin sensitivity and insulin secretion.

Detailed description

A randomized, double-blind, placebo-controlled clinical trial its going to carry out in 24 patients with a diagnosis of metabolic syndrome in accordance with the International Diabetes Federation (IDF). Waist circumference, glucose, insulin levels, lipid profile, creatinine and acid uric are going to be load after a 75 g of dextrose load. 12 patients will receive Forxiga (dapagliflozin), 10 mg, one per day before breakfast during 3 months. The remaining 12 patients will receive placebo at the same dose. There will be calculated Area Under the Curve of glucose and insulin, total insulin secretion (insulinogenic index), first-phase of insulin secretion (Stumvoll index) and insulin sensitivity (Matsuda index). This protocol it's already approved by the local ethics committee and written informed consent it's going to be obtained from all volunteers. Results will be presented as mean and standard deviation. Intra and inter group differences are going to be tested using the Wilcoxon signed-rank and Mann-Whitney U-test respectively; p≤0.05 it's going to be considered significant.

Conditions

• Metabolic Syndrome X

Interventions

Type	Name	Description
DRUG	Dapagliflozin	Dapagliflozin capsules, 10 mg, one per day before breakfast during 90 days.
DRUG	Placebo	Placebo capsules, 10 mg, one per day before breakfast during 90 days.

Timeline

• Start date: 2014-04-01
• Primary completion: 2015-05-01
• Completion: 2015-05-01
• First posted: 2014-04-14
• Last updated: 2020-10-28
• Results posted: 2020-10-08

Locations

1 site across 1 country: Mexico