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Clinical Trial Details

Trial ID: L6786
Source ID: NCT02337933
Associated Drug: Ursolic Acid
Title: Effect of Ursolic Acid Administration on Insulin Sensitivity and Metabolic Syndrome
Acronym:
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT02337933/results
Conditions: Metabolic Syndrome X
Interventions: DRUG: Ursolic acid|DRUG: Placebo
Outcome Measures: Primary: Total Insulin Sensitivity, The insulin sensitivity was calculated at baseline and at week 12. The value reported corresponds at week 12 with Matsuda index. 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, Week 12|Waist Circumference, Waist circumference was evaluated at baseline and at week 12 with a flexible tape and the entered values reflect the waist circumference measure at week 12, Week 12|Fasting Glucose, The fasting glucose levels were evaluated at baseline and week 12 with enzymatic/colorimetric techniques and the entered values reflect the fasting glucose level at week 12, Week 12|Triglycerides, The triglycerides were evaluated at baseline and week 12 with enzymatic-colorimetric techniques and the entered values reflect the triglycerides level at week 12, Week 12|High Density Lipoprotein Cholesterol (HDL-c), The HDL-c levels were evaluated at baseline and week 12 with enzymatic/colorimetric techniques and the entered values reflect the c-HDL level at week 12, Week 12|Systolic Blood Pressure, The systolic blood pressure was evaluated at baseline and week 12 with a digital sphygmomanometer and the entered values reflect the systolic blood pressure at week 12, Week 12|Diastolic Blood Pressure, The diastolic blood pressure was evaluated at baseline and week 12 with a digital sphygmomanometer and the entered values reflect the diastolic blood pressure at week 12, Week 12 | Secondary: Body Weight, The body weight was measured at baseline and week 12 with a bioimpedance balance and the entered values reflect the weight at week 12, Week 12|Body Mass Index, The Body Mass index was calculated at baseline and at week 12 with the Quetelet index and the entered values reflect the body mass index at week 12, Week 12|Total Cholesterol, The total cholesterol was estimated by standardized techniques at baseline and week 12 and the entered values reflect the total cholesterol level at week 12, Week 12|Low Density Lipoproteins Cholesterol (LDL-c), The LDL-c levels were measured at baseline and at week 12 with standardized techniques and the entered values reflect the c-LDL levels at week 12, Week 12|Creatinine, The creatinine levels were measured at baseline and at week 12 with standardized techniques and the entered values reflect the creatinine levels at week 12, Week 12|Uric Acid, The uric acid levels were measured at baseline and at week 12 with standardized techniques and the entered values reflect the uric acid levels at week 12, Week 12
Sponsor/Collaborators: Sponsor: University of Guadalajara
Gender: ALL
Age: ADULT
Phases: PHASE2
Enrollment: 24
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2014-09
Completion Date: 2015-09
Results First Posted: 2020-10-08
Last Update Posted: 2020-10-08
Locations: Instituto de Terapéutica Experimental y Clínica, Guadalajara, Jalisco, 44140, Mexico
URL: https://clinicaltrials.gov/show/NCT02337933