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

Information source: University of Guadalajara
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Metabolic Syndrome X

Intervention: Dapagliflozin (Drug); Placebo (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: University of Guadalajara

Official(s) and/or principal investigator(s):
MANUEL GONZALEZ, PhD, Principal Investigator, Affiliation: University of Guadalajara

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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome:

Change from baseline of waist circumference at week 12.

Change from baseline of triglycerides levels at week 12.

Change from baseline of high density lipoprotein (c-HDL) levels at week 12.

Change from baseline of fasting glucose levels at week 12.

Change from baseline of blood pressure at week 12.

Change from baseline of first phase of insulin secretion at week 12.

Change from baseline of total insulin secretion at week 12.

Change from baseline of total insulin sensitivity at week 12.

Secondary outcome:

Change from baseline of weight at week 12.

Change from baseline of Body Mass Index at week 12

Change from baseline of total cholesterol at week 12

Change from baseline of low density lipoproteins (c-LDL) at week 12

Change from baseline of hepatic transaminases at week 12.

Change from baseline of creatinine at week 12.

Change from baseline of uric acid at week 12.

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.

Eligibility

Minimum age: 30 Years. Maximum age: 60 Years. Gender(s): Both.

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

Locations and Contacts

Intstituto de Terapeútica Experimental y Clínica. Centro Universitario de Ciencias de la Salud. Universidad de Guadalajara, Guadalajara, Jalisco 44340, Mexico
Additional Information

INTERNATIONAL DIABETES FEDERATION CRITERIA FOR DIAGNOSIS OF METABOLIC SYNDROME

Starting date: April 2014
Last updated: May 26, 2015

Page last updated: August 23, 2015

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