Clinical TrialID 968

Effect of Artemisia Dracunculus on Glucose Intolerance, Insulin Sensitivity and Insulin Secretion

NCT02330341

Glucose Intolerance

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Record Fields

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Clinical Trial Id
968
Evidence Id
968
Core Evidence Id
968
Source Clinical Trial Id
949
Herb2 Clinical Trial Id
HBCT000949
Nct Id
NCT02330341
Title
Effect of Artemisia Dracunculus on Glucose Intolerance, Insulin Sensitivity and Insulin Secretion
Status
Completed
Phase
Study Result
Yes
Study Condition
Glucose Intolerance
Study Type
Interventional
Study Design
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Intervention
DIETARY_SUPPLEMENT: Artemisia dracunculus|OTHER: Placebo
Intervention Allocation
Randomized
Intervention Model
Parallel
Intervention Mask
Double
Intervention Purpose
Treatment
Gender
All
Age
Adult
Enrollment
24
Outcome Measure
Postprandial Glucose Levels at Week 12, Postprandial glucose will be evaluated at baseline and week 12 after a oral glucose tolerance test with enzymatic-colorimetric techniques, Week 12|Fasting Glucose Levels at Week 12, Fasting glucose will be evaluated at baseline and week 12 with enzymatic-colorimetric techniques, Week 12|Glycosylated Hemoglobin at Week 12, Glycosylated hemoglobin will be evaluated at baseline and week 12 by ELISA, Week 12|First Phase of Insulin Secretion at Week 12, The first phase of insulin secretion will be calculated at baseline and week 12 with Stumvoll index. 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 first phase of insulin secretion, Week 12|Total Insulin Secretion at Week 12, Total insulin secretion will be calculated at baseline and week 12 with insulinogenic index. 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 (ΔABC insulin/ΔABC glucose), the entered values reflect the total insulin secretion, Week 12|Insulin Sensitivity at Week 12, Insulin sensitivity will be calculated at baseline and 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
Sponsor Collaborator
University of Guadalajara
Funded By
OTHER
Location
Manuel González Ortiz, Guadalajara, Jalisco, 44140, Mexico
Other Id
GI-ESTRAGON
Start Date
2014-12
Primary Completion Date
2015-06
Completion Date
2015-07
First Posted
2015-01-01
Results First Posted
2020-10-08
Last Update Posted
2020-10-08
Study Document
Study Url
https://clinicaltrials.gov/study/NCT02330341
Title Cn
Title En
Effect of Artemisia Dracunculus on Glucose Intolerance, Insulin Sensitivity and Insulin Secretion
Bilingual Status
semi_complete