Clinical trial NCT02330341: Effect of Artemisia Dracunculus on Glucose Intolerance, Insulin Sensitivity and Insulin Secretion
Official title: Effect of Artemisia Dracunculus on Glucose Intolerance, Insulin Sensitivity and Insulin Secretion
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Glucose Intolerance
Keywords: Glucose Intolerance
Artemisia dracunculus
Insulin
Lead sponsor: University of Guadalajara
Sponsor class: OTHER
First posted: 2015-01-01
Enrollment: 24
Sex: ALL
Minimum age (years): 30
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 purpose: TREATMENT

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.

Detailed description: 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.

Eligibility 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

Primary outcomes:
measure: Postprandial Glucose Levels at Week 12
timeFrame: Week 12
measure: Fasting Glucose Levels at Week 12
timeFrame: Week 12
measure: Glycosylated Hemoglobin at Week 12
timeFrame: Week 12
measure: First Phase of Insulin Secretion at Week 12
timeFrame: Week 12
measure: Total Insulin Secretion at Week 12
timeFrame: Week 12
measure: Insulin Sensitivity at Week 12
timeFrame: Week 12
Secondary outcomes:
measure: Weight at Week 12
timeFrame: Week 12
measure: Body Mass Index at Week 12
timeFrame: Week 12
measure: Total Cholesterol at Week 12
timeFrame: Week 12
measure: Triglycerides Levels at Week 12
timeFrame: Week 12
measure: High Density Lipoprotein (c-HDL) Levels at Week 12
timeFrame: Week 12
measure: Alanine Aminotransferase (ALT) Levels at Week 12
timeFrame: Week 12
measure: Aspartate Aminotransferase (AST) Levels at Week 12
timeFrame: Week 12
measure: Creatinine Levels at Week 12
timeFrame: Week 12
measure: Uric Acid Levels at Week 12
timeFrame: Week 12
measure: Systolic Blood Pressure at Week 12
timeFrame: Week 12
measure: Diastolic Blood Pressure at Week 12.
timeFrame: Week 12
Other outcomes:
Locations:
city: Guadalajara
country: Mexico
facility: Manuel González Ortiz
state: Jalisco
Study officials:
affiliation: University of Guadalajara
name: MANUEL GONZALEZ, PhD
role: PRINCIPAL_INVESTIGATOR
References: