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Clinical Trial Details

Trial ID: L7043
Source ID: NCT02397447
Associated Drug: Momordica Charantia
Title: Effect of Momordica Charantia Administration on Type 2 Diabetes Mellitus, Insulin Sensitivity and Insulin Secretion
Acronym:
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT02397447/results
Conditions: Diabetes Mellitus Type 2
Interventions: DRUG: Momordica charantia|DRUG: Placebo
Outcome Measures: Primary: Total and First Phase of Insulin Secretion (Insulinogenic Index and Stumvoll Index) After 90 Days, Total insulin secretion and first phase of insulin secretion were estimated at baseline and after 90 days using the insulinogenic index (ΔABC insulin / ΔABC glucose) and the Stumvoll index (1283+ 1.829 x insulin 30' - 138.7 x glucose 30' + 3.772 x insulin 0'), respectively, 90 days|Insulin Sensitivity (Matsuda Index) After 90 Days, Insulin sensitivity was calculated at baseline and after 90 days with Matsuda index \[10,000 / √glucose 0' x insulin 0') (mean glucose oral glucose tolerance test (OGTT) x mean insulin OGTT)\], 90 days | Secondary: Fasting Serum Glucose (FSG) After 90 Days, The glucose oxidase technique (Beckman Instruments, Inc., Brea, CA, USA) was used to determine fasting serum glucose at baseline and after 90 days with an intra- and interassay coefficient of variation of\<1, 90 days|A1C After 90 Days, A liquid chromatography method was used to evaluate A1C at baseline and after 90 days (Bio-Rad Laboratories, Hercules, CA, USA) with an intra and inter assay coefficient of variation of 0.4% and 1.6%, respectively, 90 days|Total Cholesterol After 90 Days, The blood sample for the determination of total cholesterol was taken after an overnight fast and was evaluated at baseline and after 90 days by spectrophotometry method, 90 days|Triglycerides After 90 Days, The blood sample for the determination of triglycerides was taken after an overnight fast and was evaluated at baseline and after 90 days by spectrophotometry method, 90 days|High Density Lipoprotein Cholesterol (HDL-c) After 90 Days, The blood sample for the determination of high density lipoprotein cholesterol was taken after an overnight fast and was evaluated at baseline and after 90 days by spectrophotometry method, 90 days|Low Density Lipoprotein Cholesterol (LDL-c) After 90 Days, The blood sample for the determination of low density lipoprotein cholesterol was taken after an overnight fast and was evaluated at baseline and after 90 days by spectrophotometry method, 90 days|Very Low Density Lipoprotein After 90 Days, The blood sample for the determination of VLDL was taken after an overnight fast and was calculated at baseline and after 90 days as triglycerides/5, 90 days|Alanine Aminotransferase (ALT) After 90 Days, The blood sample for the determination of ALT was taken after an overnight fast and was evaluated at baseline and after 90 days by spectrophotometry method, 90 days|Aspartate Aminotransferase (AST) After 90 Days, The blood sample for the determination of AST was taken after an overnight fast and was evaluated at baseline and after 90 days by spectrophotometry method, 90 days|Creatinine After 90 Days, The blood sample for the determination of creatinine was taken after an overnight fast and was evaluated at baseline and after 90 days by spectrophotometry method, 90 days|Systolic Blood Pressure After 90 Days, The systolic blood pressure was evaluated at baseline and after 90 days with a digital sphygmomanometer with the subject sited down on a chair after a resting period of 5 minutes on three occasions. The mean of the three measures was considered as the value of SBP. The value was expressed on mmHg, 90 days|Diastolic Blood Pressure After 90 Days, The diastolic blood pressure was evaluated at baseline and after 90 days with a digital sphygmomanometer with the subject sited down on a chair after a resting period of 5 minutes on three occasions. The mean of the three measures was considered as the value of DBP. The value was expressed on mmHg, 90 days|Body Weight (BW) After 90 Days, The body weight was evaluated at baseline and after 90 days after an overnight fast, through a bioimpedance digital scale results are reported in kilograms with a decimal., 90 days|Body Mass Index (BMI) After 90 Days, The BMI was calculated at baseline and after 90 days by the square of the body height, and is universally expressed in units of kg/m\^2, resulting from mass in kilograms and height in metres, 90 days|Fat Mass After 90 Days, Fat mass was measured at baseline and after 90 days with an electric bioimpedance scale (Model TBF-300 A; Tanita Corporation of America Inc., Arlington Heights, IL), 90 days|Waist Circumference (WC) After 90 Days, The waist circumference was evaluated at baseline and after 90 days after an overnight fast with a flexible tape in the midpoint between the lowest rib and the iliac crest and is expressed in centimeters, 90 days|2-h Serum Glucose After 90 Days, The glucose oxidase technique (Beckman Instruments, Inc., Brea, CA, USA) was used to determine serum glucose at baseline and after 90 days with an intra- and interassay coefficient of variation of\<1%, 90 days|AUC-glucose After 90 Days, The polygonal formula was used to calculate area under the curve (AUC) of glucose at baseline and after 90 days, 90 days|AUC-insulin After 90 Days, The polygonal formula was used to calculate area under the curve (AUC) of insulin at baseline and after 90 days, 90 days
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: 2013-03
Completion Date: 2015-11
Results First Posted: 2020-10-22
Last Update Posted: 2020-10-22
Locations: Institute of Experimental and Clinical Therapeutics (INTEC), CUCS, University of Guadalajara, Guadalajara, Jalisco, 44340, Mexico
URL: https://clinicaltrials.gov/show/NCT02397447