Overview

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

Status:
Completed
Trial end date:
2017-02-01
Target enrollment:
0
Participant gender:
All
Summary
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.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
University of Guadalajara
Treatments:
Dapagliflozin
Insulin
Criteria
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