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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-12-31

Study Completion Date

2015-07-31

Brief Summary

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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.

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Detailed Description

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A randomized, double-blind, placebo-controlled clinical trial will be carried out in 24 patients with diagnosis of glucose intolerance in accordance with the criteria of American Diabetes Association (ADA). Glucose, insulin levels, lipid profile, creatinine, uric acid, and transaminases will be evaluated. An oral glucose tolerance test with 75 g of dextrose will be held.

12 participants will receive Artemisia dracunculus, 1000 mg, twice per day (2000 mg) before breakfast and dinner during 3 months. And other 12 patients will receive placebo with the same prescription.

Area Under de Curve of glucose and insulin will be calculated as well as total insulin secretion (insulinogenic index), first-phase of insulin secretion (Stumvoll index) and insulin sensitivity (Matsuda index).

This protocol is approved by a local ethics committee and written informed consent will be obtained from all volunteers.

Results will be presented as mean and standard deviation. Intra an inter group differences will be tested using the Wilcoxon signed-ran and Mann Whitney U- test respectively; p\<0.05 will be considered significant.

Conditions

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Glucose Intolerance

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Artemisia Dracunculus

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

Group Type EXPERIMENTAL

Artemisia dracunculus

Intervention Type DIETARY_SUPPLEMENT

Placebo

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Interventions

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Artemisia dracunculus

Intervention Type DIETARY_SUPPLEMENT

Placebo

Intervention Type OTHER

Other Intervention Names

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estragon, tarragon calcined magnesia

Eligibility Criteria

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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

Minimum Eligible Age

30 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No