Clinical TrialID 127

Effect of Gymnema Sylvestre on Metabolic Syndrome and Insulin

NCT02370121

Metabolic Syndrome

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Record Fields

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Clinical Trial Id
127
Evidence Id
127
Core Evidence Id
127
Source Clinical Trial Id
122
Herb2 Clinical Trial Id
HBCT000122
Nct Id
NCT02370121
Title
Effect of Gymnema Sylvestre on Metabolic Syndrome and Insulin
Status
Completed
Phase
Phase 2
Study Result
Yes
Study Condition
Metabolic Syndrome
Study Type
Interventional
Study Design
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: TREATMENT
Intervention
DRUG: Placebo|DRUG: Gymnema Sylvestre
Intervention Allocation
Randomized
Intervention Model
Parallel
Intervention Mask
Triple
Intervention Purpose
Treatment
Gender
All
Age
Adult
Enrollment
24
Outcome Measure
Waist Circumference (WC), The WC was evaluated after an overnight fast with a flexible tape in the midpoint between the lowest rib and the iliac crest and is expressed in centimeters., Week 12|Triglycerides (TGs), The blood sample for determining of TGs, was taken after an overnight fast and was evaluated by spectrophotometry method. The value was expressed on mmol/L., week 12|High-density Lipoprotein Cholesterol (HDL-C), The blood sample for determining of HDL-C, was taken after an overnight fast and was evaluated by colorimetric method. The value was expressed on mmol/L., Week 12|Fasting Plasma Glucose (FPG), The blood sample for determining of FPG, was taken after an overnight fast and was evaluated by spectrophotometry method. The value was expressed on mmol/L., week 12|Systolic Blood Pressure (SBP), The SBP was evaluated 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., week 12|Diastolic Blood Pressure (DBP), The DBP was evaluated 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., week 12|Total Insulin Secretion, The total insulin secretion was calculated by the insulinogenic index (ΔABC insulin / ΔABC glucose)., Week 12|First Phase of Insulin Secretion, The 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')., week 12|Insulin Sensitivity, The insulin sensitivity was calculated with Matsuda index \[10,000 / √glucose 0' x insulin 0') (mean glucose oral glucose tolerance test (OGTT) x mean insulin OGTT)\]., week 12
Sponsor Collaborator
University of Guadalajara
Funded By
OTHER
Location
Other Id
CT-271281-YZ
Start Date
2013-02
Primary Completion Date
2014-12
Completion Date
2015-01
First Posted
2015-02-24
Results First Posted
2016-06-03
Last Update Posted
2019-06-18
Study Document
Study Url
https://clinicaltrials.gov/study/NCT02370121
Title Cn
Title En
Effect of Gymnema Sylvestre on Metabolic Syndrome and Insulin
Bilingual Status
semi_complete