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

October 6, 2020 updated by: Manuel González Ortiz, University of Guadalajara

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Mexico
    • Jalisco
      • Guadalajara, Jalisco, Mexico, 44340
        • Instituto de Terapeútica Experimental y Clínica. Centro Universitario de Ciencias de la Salud. Universidad de Guadalajara

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

28 years to 58 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Dapagliflozin
Dapagliflozin capsules, 10 mg, one per day before breakfast during 90 days.
Drug: Dapagliflozin
Dapagliflozin capsules, 10 mg, one per day before breakfast during 90 days.
Other Names:
  • Forxiga
Placebo Comparator: Placebo
Placebo 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.
Other Names:
  • Calcined magnesium

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Waist Circumference at Week 12.
Time Frame: Week 12
The waist circumference is going to be evaluated at week 12 with a flexible tape with standardized techniques.
Week 12
Triglycerides Levels at Week 12.
Time Frame: Week 12
The triglycerides levels are going to be evaluated at week 12 with enzymatic-colorimetric techniques.
Week 12
High Density Lipoprotein (c-HDL) Levels at Week 12.
Time Frame: Week 12
The c-HDL levels are going to be evaluated at week 12 with enzymatic/colorimetric techniques.
Week 12
Glucose Levels at Minute 0 at Week 12.
Time Frame: Week 12
The fasting glucose (0') levels are going to be evaluated at week 12 with enzymatic/colorimetric techniques.
Week 12
Systolic Blood Pressure at Week 12.
Time Frame: Week 12
The systolic blood pressure is going to be evaluated at week 12 with a digital sphygmomanometer.
Week 12
Diastolic Blood Pressure at Week 12.
Time Frame: Week 12
The diastolic blood pressure is going to be evaluated at week 12 with a digital sphygmomanometer.
Week 12
Insulinogenic Index (Total Insulin Secretion) at Week 12.
Time Frame: Week 12

The insulinogenic index is a ratio that relates enhancement of circulating insulin to the magnitude of the corresponding glycemic stimulus.

Total insulin secretion was calculated with the insulinogenic index (ΔAUC insulin/ΔAUC glucose), the entered values reflect the total insulin secretion at week 12.
Week 12
Stumvoll Index (First Phase of Insulin Secretion) at Week 12.
Time Frame: Week 12

Human studies support the critical physiologic role of the first-phase of insulin secretion in the maintenance of postmeal glucose homeostasis.

First phase of insulin secretion was estimated using the Stumvoll index (1283+ 1.829 x insulin 30' - 138.7 x glucose 30' + 3.772 x insulin 0'), the entered values reflect the frst phase of insulin secretion at week 12.
Week 12
Matsuda Index (Total Insulin Sensitivity) at Week 12.
Time Frame: Week 12
Matsuda Index value is used to indicate insulin resistance on diabetes. Insulin sensitivity was calculated with Matsuda index [10,000 / √glucose 0' x insulin 0') (mean glucose oral glucose tolerance test (OGTT) x mean insulin OGTT)]. The entered values reflect the insulin sensitivity at week 12.
Week 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Body Weight at Week 12.
Time Frame: Week 12
The weight it's going to be measured at week 12 with a bioimpedance balance.
Week 12
Body Mass Index at Week 12
Time Frame: Week 12
The Body Mass index it's going to be calculated at week 12 with the Quetelet index.
Week 12
Fat Mass at Week 12.
Time Frame: Week 12
The fat mass is going to be evaluated at week 12 through bioimpedance.
Week 12
Total Cholesterol at Week 12
Time Frame: Week 12
The total cholesterol will be estimated by standardized techniques at week 12.
Week 12
Low Density Lipoproteins (c-LDL) at Week 12
Time Frame: Week 12
The c-LDL levels are going to be measured at week 12 with standardized techniques.
Week 12
Alanine Aminotransferase (ALT) at Week 12.
Time Frame: Week 12.
The ALT hepatic transaminase levels are going to be measured at week 12 with standardized techniques.
Week 12.
Aspartate Aminotransferase (AST) at Week 12.
Time Frame: Week 12
The hepatic transaminase AST will be evaluated with standardized methods at week 12
Week 12
Creatinine at Week 12.
Time Frame: Week 12.
The creatinine levels are going to be measured at week 12 with standardized techniques.
Week 12.
Uric Acid at Week 12.
Time Frame: Week 12.
The uric acid levels are going to be measured at week 12 with standardized techniques.
Week 12.
AUC of Glucose at Week 12.
Time Frame: Week 12
The AUC of glucose will be calculated from the glucose values obtained from the minuted oral glucose tolerance curve at week 12
Week 12
AUC of Insulin at Week 12.
Time Frame: Week 12
The AUC will be calculated from the insulin values obtained from the minuted oral glucose tolerance curve at week 12
Week 12
Glucose at Minute 30 at Week 12.
Time Frame: Week 12
The glucose at minute 30 is going to be evaluated at week 12 during a minuted oral glucose tolerance curve
Week 12
Glucose at Minute 60 at Week 12.
Time Frame: Week 12
The glucose at minute 60 is going to be evaluated at week 12 during a minuted oral glucose tolerance curve
Week 12
Glucose at Minute 90 at Week 12.
Time Frame: Week 12
The glucose at minute 90 is going to be evaluated at week 12 during a minuted oral glucose tolerance curve
Week 12
Glucose at Minute 120 at Week 12.
Time Frame: Week 12
The glucose at minute 120 is going to be evaluated at week 12 during a minuted oral glucose tolerance curve
Week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Guadalajara

Investigators

  • Principal Investigator: MANUEL GONZALEZ, PhD, University of Guadalajara

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2014

Primary Completion (Actual)

May 1, 2015

Study Completion (Actual)

May 1, 2015

Study Registration Dates

First Submitted

April 8, 2014

First Submitted That Met QC Criteria

April 9, 2014

First Posted (Estimate)

April 14, 2014

Study Record Updates

Last Update Posted (Actual)

October 28, 2020

Last Update Submitted That Met QC Criteria

October 6, 2020

Last Verified

October 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DAPA-MS

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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