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Completed

NCT Number: NCT02700334

Effect of Dapagliflozin on Insulin Secretion and Insulin Sensitivity in Patients With Prediabetes

Prediabetes is a term that refers to alterations in glucose homeostasis, including impaired fasting glucose (IFG), impaired glucose tolerance (IGT) or both, involving a higher risk of progression type 2 diabetes mellitus (T2DM).

Dapagliflozin is a selective and reversible inhibitor of sodium-glucose type 2 (SGLT-2) co-transporter, which reduces renal glucose reabsorption and promotes the glucose excretion through urine, so that the blood glucose is improved in patients with T2DM. Although this mechanism is independent of insulin, there are evidence of improved secretion and insulin sensitivity, so it is interesting to assess these effects in patients with prediabetes, as potential therapy for treating such disorders and prevent progression to T2DM.

The aim of this study is to evaluate the effect of Dapagliflozin on insulin secretion and insulin sensitivity in patients with prediabetes.

The investigators hypothesis is that the administration of dapagliflozin improve insulin secretion and insulin sensitivity in patients with prediabetes.

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Key information

Conditions

PreDiabetes Diabetes Mellitus Endocrine System Diseases Glucose Intolerance Glucose Metabolism Disorders Hyperglycemia Impaired Fasting Glucose Impaired Glucose Tolerance Metabolic Diseases Nutritional and Metabolic Diseases Prediabetic State

Age range

30 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Intstituto 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 in 24 patients with a diagnosis of prediabetes in accordance with the American Diabetes Association (ADA) without treatment.

They will be assigned randomly two groups of 12 patients each to receive 10 mg of Dapagliflozin (Forxiga, Astra Zeneca) or placebo, one per day before breakfast during 12 weeks.

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.

Statistical analysis will be presented through measures of central tendency and dispersion, average and deviation standard for quantitative variables; frequencies and percentages for variable qualitative. Qualitative variables will be analyzed by X2, will be used for differences inter-group Mann-Whitney U Test and Wilcoxon Test for the within-groups differences. It will be considered statistical significance p ≤0.05.

This protocol was approved by a local ethics committee and written informed consent will be obtained from all volunteers.

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
  • Diagnosis of prediabetes according ADA criteria (fasting blood glucose levels between 100-126 mg/dl; postprandial blood glucose levels after an oral glucose tolerance test with 75 of oral glucose between 140-199 mg/dl; or glycosylated hemoglobin between 5.7-6.4%)
  • Informed consent signed

Exclusion criteria

  • Women with confirmed or suspected pregnancy
  • Women under lactation and/or puerperium
  • Hypersensibility to ingredients of intervention
  • Physical impossibility for taking pills
  • Known uncontrolled renal, hepatic, heart or thyroid diseased
  • Diabetes diagnosis
  • Previous treatment for glucose
  • Body Mass Index ≥35 kg/m2
  • 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

10 mg, one per day before breakfast during 12 weeks.

Other names: Forxiga

Placebo

Drug

one per day before breakfast during 12 weeks.

Other names: Calcined magnesium

Primary outcomes

  1. Fasting Glucose

    Time frame: Fasting Glucose levels at week 12

    The fasting glucose levels will be evaluated with enzymatic/colorimetric techniques and the entered values reflect the fasting glucose level at week 12

  2. Postprandial Glucose

    Time frame: Postprandial Glucose levels at Week 12

    Postprandial glucose will be evaluated after a oral glucose tolerance test with enzymatic/colorimetric techniques and the entered values reflect the insulin sensitivity at week 12

  3. First Phase of Insulin Secretion

    Time frame: First Phase of Insulin Secretion at Week 12

    The first phase of insulin secretion will be calculated with Stumvoll index and the entered values reflect the frst phase of insulin secretion at 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 first phase of insulin secretion

  4. Total Insulin Secretion

    Time frame: Total Insulin Secretion at Week 12

    Total insulin secretion will be calculated with insulinogenic index and the entered values reflect the total insulin secretion at 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 (ΔABC insulin/ΔABC glucose), the entered values reflect the total insulin secretion

  5. Insulin Sensitivity

    Time frame: Insulin Sensitivity at Week 12

    Insulin sensitivity will be calculated with Matsuda index and the entered values reflect the insulin sensitivity at 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

  6. Glycosylated Hemoglobin

    Time frame: Glycosylated Hemoglobin at Week 12

    Glycosylated hemoglobin will be evaluated by ELISA and the entered values reflect the glycosylated hemoglobin at week 12

Secondary outcomes

  1. Body Weight

    Time frame: Body Weight at Week 12

    The body weight will be measured with a bioimpedance balance and the entered values reflect the body weight at week 12

  2. Body Mass Index

    Time frame: Body Mass Index at Week 12

    Body Mas Index will be calculated with the Quetelet index formula and the entered values reflect the body mass index at week 12

  3. Total Cholesterol

    Time frame: Total Cholesterol levels at Week 12

    Total cholesterol levels will be evaluated by enzymatic/colorimetric techniques and the entered values reflect the total cholesterol level at week 12

  4. Triglycerides

    Time frame: Triglycerides levels at Week 12

    Triglycerides levels will be evaluated with enzymatic/colorimetric techniques and the entered values reflect the triglycerides level at week 12

  5. High Density Lipoprotein Cholesterol (HDL-c)

    Time frame: HDL-c levels at Week 12

    HDL-c levels will be evaluated with enzymatic/colorimetric techniques and the entered values reflect the c-HDL level at week 12

  6. Alanine Aminotransferase (ALT)

    Time frame: ALT levels at Week 12

    ALT levels will be evaluated with enzymatic/colorimetric techniques at week 12

  7. Aspartate Aminotransferase (AST)

    Time frame: AST levels at Week 12

    AST levels will be evaluated with enzymatic/colorimetric techniques at week 12

  8. Creatinine

    Time frame: Creatinine levels at Week 12

    Creatinine levels will be evaluated with enzymatic/colorimetric techniques at week 12

  9. Uric Acid

    Time frame: Uric Acid levels at Week 12

    Uric acid levels will be evaluated with enzymatic/colorimetric techniques at week 12

  10. Systolic Blood Pressure

    Time frame: Systolic Blood Pressure at Week 12

    Systolic Blood pressure will be measured with a digital sphygmomanometer and the entered values reflect the blood pressure at week 12

  11. Diastolic Blood Pressure

    Time frame: Diastolic Blood Pressure at Week 12

    Systolic Blood pressure will be measured with a digital sphygmomanometer and the entered values reflect the blood pressure at week 12

Sponsors and collaborators

Lead sponsor

University of Guadalajara

Other

Registry information

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Mar 7, 2016
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.

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