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

• Status: Completed
• Trial end date: 2015-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Guadalajara
• Treatments: Dapagliflozin; Insulin; Insulin, Globin Zinc

Criteria

Inclusion Criteria:

• Patients both sexes

• Age between 30 and 60 years

• Metabolic Syndrome according to the IDF criteria

• Waist circumference

• Man ≥90 cm

• Woman ≥80 cm

• And two of the following criteria

• High density lipoprotein

• Man ≤40 mg/dL

• Woman ≤50 mg/dL

• Fasting glucose ≥100 mg/dL

• Triglycerides ≥150 mg/dL

• Blood pressure ≥130/85 mmHg

• Informed consent signed

Exclusion Criteria:

• Women with confirmed or suspected pregnancy

• Women under lactation and/or puerperium

• Hypersensibility to SGLT2 inhibitors

• Physical impossibility for taking pills

• Known uncontrolled renal, hepatic, heart or thyroid diseased

• Previous treatment for the metabolic syndrome components

• Body Mass Index ≥39.9 kg/m2

• Fasting glucose ≥126 mg/dL

• Triglycerides ≥500 mg/dL

• Total cholesterol ≥240 mg/dL

• Low density lipoprotein (c-LDL) ≥190 mg/dL

• Blood Pressure ≥140/90 mmHg