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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02330341
• Date of registration: 30/12/2014
• Prospective Registration: No
• Primary sponsor: University of Guadalajara
• Public title: Effect of Artemisia Dracunculus on Glucose Intolerance, Insulin Sensitivity and Insulin Secretion
• Scientific title: Effect of Artemisia Dracunculus on Glucose Intolerance, Insulin Sensitivity and Insulin Secretion
• Date of first enrolment: December 2014
• Target sample size: 24
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02330341
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
• Phase: N/A

Countries of recruitment

Mexico

Contacts

• Name: MANUEL GONZALEZ, PhD
• Affiliation: University of Guadalajara

Key inclusion & exclusion criteria

Inclusion Criteria:

- Patients both sexes

- Age between 30 and 60 years

- Glucose intolerance according ADA criteria (blood glucose leve =140 mg/dl and =199
mg/dL after an oral glucose tolerance test with 75 of oral glucose

- Informed consent signed

Exclusion Criteria:

- Women with confirmed or suspected pregnancy

- Women under lactation and/or puerperium

- Hypersensibility to Artemisia dracunculus

- Physical impossibility for taking pills

- Known uncontrolled renal, hepatic, heart or thyroid disease

- Previous treatment for glucose

- Diabetes diagnosis

- BMI =39.9 kg/m2



Age minimum: 30 Years
Age maximum: 60 Years
Gender: All

Health Condition(s) or Problem(s) studied

Glucose Intolerance

Intervention(s)

Dietary Supplement: Artemisia dracunculus

Other: Placebo

Primary Outcome(s)

Insulin Sensitivity at Week 12 [Time Frame: Week 12]

Total Insulin Secretion at Week 12 [Time Frame: Week 12]

Glycosylated Hemoglobin at Week 12 [Time Frame: Week 12]

Postprandial Glucose Levels at Week 12 [Time Frame: Week 12]

Fasting Glucose Levels at Week 12 [Time Frame: Week 12]

First Phase of Insulin Secretion at Week 12 [Time Frame: Week 12]

Secondary Outcome(s)

Creatinine Levels at Week 12 [Time Frame: Week 12]

Systolic Blood Pressure at Week 12 [Time Frame: Week 12]

Weight at Week 12 [Time Frame: Week 12]

Body Mass Index at Week 12 [Time Frame: Week 12]

High Density Lipoprotein (c-HDL) Levels at Week 12 [Time Frame: Week 12]

Aspartate Aminotransferase (AST) Levels at Week 12 [Time Frame: Week 12]

Triglycerides Levels at Week 12 [Time Frame: Week 12]

Alanine Aminotransferase (ALT) Levels at Week 12 [Time Frame: Week 12]

Diastolic Blood Pressure at Week 12. [Time Frame: Week 12]

Total Cholesterol at Week 12 [Time Frame: Week 12]

Uric Acid Levels at Week 12 [Time Frame: Week 12]

Secondary ID(s)

GI-ESTRAGON

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 08/10/2020
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02330341