Prediabetes Clinical Trial
Official title:
Effect of Dapagliflozin on Insulin Secretion and Insulin Sensitivity in Patients With Prediabetes
Verified date | October 2020 |
Source | University of Guadalajara |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 24 |
Est. completion date | February 2017 |
Est. primary completion date | January 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 30 Years to 60 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Mexico | Intstituto de Terapeútica Experimental y Clínica. Centro Universitario de Ciencias de la Salud. Universidad de Guadalajara | Guadalajara | Jalisco |
Lead Sponsor | Collaborator |
---|---|
University of Guadalajara |
Mexico,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Fasting Glucose | The fasting glucose levels will be evaluated with enzymatic/colorimetric techniques and the entered values reflect the fasting glucose level at week 12 | Fasting Glucose levels at week 12 | |
Primary | Postprandial Glucose | 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 | Postprandial Glucose levels at Week 12 | |
Primary | First Phase of Insulin Secretion | 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 |
First Phase of Insulin Secretion at Week 12 | |
Primary | Total Insulin Secretion | 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 (?ABC insulin/?ABC glucose), the entered values reflect the total insulin secretion |
Total Insulin Secretion at Week 12 | |
Primary | Insulin Sensitivity | 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 / vglucose 0' x insulin 0') (mean glucose oral glucose tolerance test (OGTT) x mean insulin OGTT)]. The entered values reflect the insulin sensitivity |
Insulin Sensitivity at Week 12 | |
Primary | Glycosylated Hemoglobin | Glycosylated hemoglobin will be evaluated by ELISA and the entered values reflect the glycosylated hemoglobin at week 12 | Glycosylated Hemoglobin at Week 12 | |
Secondary | Body Weight | The body weight will be measured with a bioimpedance balance and the entered values reflect the body weight at week 12 | Body Weight at Week 12 | |
Secondary | Body Mass Index | Body Mas Index will be calculated with the Quetelet index formula and the entered values reflect the body mass index at week 12 | Body Mass Index at Week 12 | |
Secondary | Total Cholesterol | Total cholesterol levels will be evaluated by enzymatic/colorimetric techniques and the entered values reflect the total cholesterol level at week 12 | Total Cholesterol levels at Week 12 | |
Secondary | Triglycerides | Triglycerides levels will be evaluated with enzymatic/colorimetric techniques and the entered values reflect the triglycerides level at week 12 | Triglycerides levels at Week 12 | |
Secondary | High Density Lipoprotein Cholesterol (HDL-c) | HDL-c levels will be evaluated with enzymatic/colorimetric techniques and the entered values reflect the c-HDL level at week 12 | HDL-c levels at Week 12 | |
Secondary | Alanine Aminotransferase (ALT) | ALT levels will be evaluated with enzymatic/colorimetric techniques at week 12 | ALT levels at Week 12 | |
Secondary | Aspartate Aminotransferase (AST) | AST levels will be evaluated with enzymatic/colorimetric techniques at week 12 | AST levels at Week 12 | |
Secondary | Creatinine | Creatinine levels will be evaluated with enzymatic/colorimetric techniques at week 12 | Creatinine levels at Week 12 | |
Secondary | Uric Acid | Uric acid levels will be evaluated with enzymatic/colorimetric techniques at week 12 | Uric Acid levels at Week 12 | |
Secondary | Systolic Blood Pressure | Systolic Blood pressure will be measured with a digital sphygmomanometer and the entered values reflect the blood pressure at week 12 | Systolic Blood Pressure at Week 12 | |
Secondary | Diastolic Blood Pressure | Systolic Blood pressure will be measured with a digital sphygmomanometer and the entered values reflect the blood pressure at week 12 | Diastolic Blood Pressure at Week 12 |
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