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Clinical Trial Details

Trial ID: L4146
Source ID: NCT02700334
Associated Drug: Dapagliflozin
Title: Effect of Dapagliflozin on Insulin Secretion and Insulin Sensitivity in Patients With Prediabetes
Acronym:
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT02700334/results
Conditions: Prediabetes|Impaired Fasting Glucose|Impaired Glucose Tolerance
Interventions: DRUG: Dapagliflozin|DRUG: Placebo
Outcome Measures: 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|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|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|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 (ΔABC insulin/ΔABC glucose), the entered values reflect the total insulin secretion, Total Insulin Secretion at Week 12|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 \[10,000 / √glucose 0' x insulin 0') (mean glucose oral glucose tolerance test (OGTT) x mean insulin OGTT)\]. The entered values reflect the insulin sensitivity, Insulin Sensitivity at Week 12|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|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|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|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|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|Alanine Aminotransferase (ALT), ALT levels will be evaluated with enzymatic/colorimetric techniques at week 12, ALT levels at Week 12|Aspartate Aminotransferase (AST), AST levels will be evaluated with enzymatic/colorimetric techniques at week 12, AST levels at Week 12|Creatinine, Creatinine levels will be evaluated with enzymatic/colorimetric techniques at week 12, Creatinine levels at Week 12|Uric Acid, Uric acid levels will be evaluated with enzymatic/colorimetric techniques at week 12, Uric Acid levels at Week 12|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|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
Sponsor/Collaborators: Sponsor: University of Guadalajara
Gender: ALL
Age: ADULT
Phases: PHASE4
Enrollment: 24
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2016-10
Completion Date: 2017-02
Results First Posted: 2020-10-08
Last Update Posted: 2020-10-28
Locations: Intstituto de Terapeútica Experimental y Clínica. Centro Universitario de Ciencias de la Salud. Universidad de Guadalajara, Guadalajara, Jalisco, 44340, Mexico
URL: https://clinicaltrials.gov/show/NCT02700334