Clinical TrialID 126

Effect of Gymnema Sylvestre on Patients With Impaired Glucose Tolerance.

NCT02708966

Impaired Glucose Tolerance

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Record Fields

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Clinical Trial Id
126
Evidence Id
126
Core Evidence Id
126
Source Clinical Trial Id
121
Herb2 Clinical Trial Id
HBCT000121
Nct Id
NCT02708966
Title
Effect of Gymnema Sylvestre on Patients With Impaired Glucose Tolerance.
Status
Completed
Phase
Phase 2
Study Result
Yes
Study Condition
Impaired Glucose Tolerance
Study Type
Interventional
Study Design
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Intervention
DRUG: Gymnema Sylvestre|DRUG: Placebo
Intervention Allocation
Randomized
Intervention Model
Parallel
Intervention Mask
Double
Intervention Purpose
Treatment
Gender
All
Age
Adult
Enrollment
30
Outcome Measure
Fasting Plasma Glucose, After intervention by spectrophotometry, 90 days|2-hour Post Load Plasma Glucose (2-h PG), The blood sample for determining of 2-h PG, was taken two hours after the ingestion of the drink with 75 g dextrose and was evaluated by spectrophotometry method. The value was expressed on mmol/L., 90 days|Glycated Hemoglobin A1c (A1C), After intervention by high-performance liquid chromatography, 90 days|Total Insulin Secretion (Insulinogenic Index), Total insulin secretion was calculated with the insulinogenic index (ΔABC insulin / ΔABC glucose) after intervention., 90 days|First Phase of Insulin Secretion, 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') after intervention., 90 days|Insulin Sensitivity (Matsuda Index), Insulin sensitivity was calculated with Matsuda index \[10,000 / √glucose 0' x insulin 0') (mean glucose oral glucose tolerance test (OGTT) x mean insulin OGTT)\] after intervention., 90 days
Sponsor Collaborator
University of Guadalajara
Funded By
OTHER
Location
Institute of Experimental and Clinical Therapeutics (INTEC), CUCS, University of Guadalajara, Guadalajara, Jalisco, 44340, Mexico
Other Id
GSIG
Start Date
2016-03
Primary Completion Date
2018-09
Completion Date
2018-10
First Posted
2016-03-15
Results First Posted
2020-11-18
Last Update Posted
2021-02-02
Study Document
Study Protocol, Statistical Analysis Plan, and Informed Consent Form, https://cdn.clinicaltrials.gov/large-docs/66/NCT02708966/Prot_SAP_ICF_000.pdf
Study Url
https://clinicaltrials.gov/study/NCT02708966
Title Cn
Title En
Effect of Gymnema Sylvestre on Patients With Impaired Glucose Tolerance.
Bilingual Status
semi_complete