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

Conditions

• Metabolic Syndrome X

Eligibility Criteria

Sex

ALL

Age

30 Years - 60 Years

Healthy Volunteers

Not accepted

Interventions

• Dapagliflozin — DRUG
  Dapagliflozin capsules, 10 mg, one per day before breakfast during 90 days.
• Placebo — DRUG
  Placebo capsules, 10 mg, one per day before breakfast during 90 days.

Study Details

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.

Key Dates

Start date

Apr 30, 2014

Status verified

Oct 2020

Primary completion

May 31, 2015

Completion

May 31, 2015

Study Design

Enrollment

24 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Dapagliflozin
  Dapagliflozin capsules, 10 mg, one per day before breakfast during 90 days.
• Placebo Comparator: Placebo
  Placebo capsules, 10 mg, one per day before breakfast during 90 days.

Primary Outcome Measure

Waist Circumference at Week 12. [ Time Frame: Week 12 ]