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

NCT02330341 | Completed Results

• 1 other identifier: GI-ESTRAGON
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

The term prediabetes has been used to encompass the first alterations on glucose metabolism such as impaired fasting glucose and glucose intolerance, and its early detection and treatment could prevent the appearance of diabetes mellitus type 2, a high prevalence disease worldwide. Artemisia dracunculus, also known as estragon, has been used in Ayurvedic medicine for the treatment of diabetes. Different in vitro and in vivo studies have shown that Artemisia dracunculus increases insulin signaling and improves insulin sensitivity. The aim of this study is evaluate the effect of Artemisia dracunculus on glucose intolerance, insulin sensitivity and insulin secretion.

Conditions

Glucose Intolerance

Keywords

Glucose Intolerance; Artemisia dracunculus; Insulin

Outcome Measures

Primary Outcomes (6)

• 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

Secondary Outcomes (11)

• Weight at Week 12

  Week 12

• Body Mass Index at Week 12

  Week 12

• Total Cholesterol at Week 12

  Week 12

• Triglycerides Levels at Week 12

  Week 12

• High Density Lipoprotein (c-HDL) Levels at Week 12

  Week 12

Study Arms (2)

Artemisia Dracunculus

EXPERIMENTAL

Artemisia Dracunculus extract, 2 capsules of 500 mg, two times per day before breakfast and dinner during 90 days

Dietary Supplement: Artemisia dracunculus

Placebo

PLACEBO COMPARATOR

Calcined magnesia, 2 capsules of 500 mg, two times per day before breakfast and dinner during 90 days

Other: Placebo

Interventions

Artemisia dracunculus DIETARY_SUPPLEMENT

Also known as: estragon, tarragon

Artemisia Dracunculus

Placebo OTHER

Also known as: calcined magnesia

Placebo

Eligibility Criteria

• Age: 30 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Guadalajara: lead

Study Sites (1)

Manuel González Ortiz

Guadalajara, Jalisco, 44140, Mexico

Location

MeSH Terms

Conditions

Glucose Intolerance; Insulin Resistance

Condition Hierarchy (Ancestors)

Hyperglycemia; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Hyperinsulinism

Results Point of Contact

• Title: DR. MANUEL GONZALEZ ORTIZ
• Organization: INSTITUTO DE TERAPEUTICA EXPERIMENTAL Y CLINICA, UNIVERSITY OF GUADALAJARA

uiec@prodigy.net.mx

+52 3310585200

Study Officials

• MANUEL GONZALEZ, PhD

  University of Guadalajara

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Researcher Professor

Model Details: This is a study with two groups of patients with prediabetes. One group received the investigational product (Artemisia Dracunculus) and the other received placebo as control.

Study Record Dates

• First Submitted: December 30, 2014
• First Posted: January 1, 2015
• Study Start: December 1, 2014
• Primary Completion: June 1, 2015
• Study Completion: July 1, 2015
• Last Updated: October 8, 2020
• Results First Posted: October 8, 2020

Record last verified: 2020-09

Locations

ME (1)