Clinical TrialID 152

Effect of Banaba (Lagerstroemia Speciosa) on Metabolic Syndrome, Insulin Secretion and Insulin Sensitivity

NCT02767869

Metabolic Syndrome X

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Clinical Trial Id: 152
Evidence Id: 152
Core Evidence Id: 152
Source Clinical Trial Id: 147
Herb2 Clinical Trial Id: HBCT000147
Nct Id: NCT02767869
Title: Effect of Banaba (Lagerstroemia Speciosa) on Metabolic Syndrome, Insulin Secretion and Insulin Sensitivity
Status: Completed
Phase: Phase 2
Study Result: Yes
Study Condition: Metabolic Syndrome X
Study Type: Interventional
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Intervention: DRUG: Banaba|DRUG: placebo
Intervention Allocation: Randomized
Intervention Model: Parallel
Intervention Mask: Double
Intervention Purpose: Treatment
Gender: All
Age: Adult
Enrollment: 24
Outcome Measure: Triglyceride Levels at Week 12, The triglycerides will be evaluated at week 12 with enzymatic-colorimetric techniques., Week 12|High Density Lipoprotein-cholesterol (HDL-C) Levels at Week 12, The HDL-C levels will be evaluated at week 12 with enzymatic/colorimetric techniques., Week 12|Fasting Glucose Levels at Week 12, 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|Systolic Blood Pressure at Week 12., 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|First 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 frst phase of insulin secretion at week 12., Week 12|Total Insulin Secretion at Week 12., Measure Description: 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 (ΔAUC insulin/ΔAUC glucose), the entered values reflect the total insulin secretion at week 12., Week 12|Total 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 at week 12., Week 12|Waist Circumference at Week 12, Waist circumference will be evaluated at baseline and at week 12 with a flexible tape, Week 12|Diastolic Blood Pressure at Week 12, 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
Sponsor Collaborator: University of Guadalajara
Funded By: OTHER
Location: Intstituto de Terapeútica Experimental y Clínica. Centro Universitario de Ciencias de la Salud. Universidad de Guadalajara, Guadalajara, Jalisco, 45037, Mexico
Other Id: BANABA-MS
Start Date: 2015-01
Primary Completion Date: 2016-12
Completion Date: 2017-02
First Posted: 2016-05-10
Results First Posted: 2020-10-20
Last Update Posted: 2021-01-14
Study Document
Study Url: https://clinicaltrials.gov/study/NCT02767869
Title Cn
Title En: Effect of Banaba (Lagerstroemia Speciosa) on Metabolic Syndrome, Insulin Secretion and Insulin Sensitivity
Bilingual Status: semi_complete