Skip to main content
OpenTrials
Completed

NCT Number: NCT02113241

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Metabolic Syndrome X Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Metabolic Syndrome Nutritional and Metabolic Diseases

Age range

30 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Instituto de Terapeútica Experimental y Clínica. Centro Universitario de Ciencias de la Salud. Universidad de Guadalajara

Guadalajara, Jalisco, 44340, Mexico

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dapagliflozin

Drug

Dapagliflozin capsules, 10 mg, one per day before breakfast during 90 days.

Other names: Forxiga

Placebo

Drug

Placebo capsules, 10 mg, one per day before breakfast during 90 days.

Other names: Calcined magnesium

Primary outcomes

  1. 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.

  2. Triglycerides Levels at Week 12.

    Time frame: Week 12

    The triglycerides levels are going to be evaluated at week 12 with enzymatic-colorimetric techniques.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

Secondary outcomes

  1. Body Weight at Week 12.

    Time frame: Week 12

    The weight it's going to be measured at week 12 with a bioimpedance balance.

  2. 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.

  3. Fat Mass at Week 12.

    Time frame: Week 12

    The fat mass is going to be evaluated at week 12 through bioimpedance.

  4. Total Cholesterol at Week 12

    Time frame: Week 12

    The total cholesterol will be estimated by standardized techniques at week 12.

  5. 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.

  6. 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.

  7. Aspartate Aminotransferase (AST) at Week 12.

    Time frame: Week 12

    The hepatic transaminase AST will be evaluated with standardized methods at week 12

  8. Creatinine at Week 12.

    Time frame: Week 12.

    The creatinine levels are going to be measured at week 12 with standardized techniques.

  9. Uric Acid at Week 12.

    Time frame: Week 12.

    The uric acid levels are going to be measured at week 12 with standardized techniques.

  10. 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

  11. 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

  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

  13. 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

  14. 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

  15. 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

Sponsors and collaborators

Lead sponsor

University of Guadalajara

Other

Registry information

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Apr 14, 2014
Registry last updated
Oct 28, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.