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

Not Applicable

Completed

Conditions: Glucose Intolerance

Interventions: Other: Placebo
Dietary Supplement: Artemisia dracunculus

Registration Number: NCT02330341

Lead Sponsor: University of Guadalajara

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 24

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Calcined magnesia, 2 capsules of 500 mg, two times per day before breakfast and dinner during 90 days
Artemisia Dracunculus	Artemisia dracunculus	Artemisia Dracunculus extract, 2 capsules of 500 mg, two times per day before breakfast and dinner during 90 days

Primary Outcome Measures

Name	Time	Method
Postprandial Glucose Levels at Week 12	Week 12	Postprandial glucose will be evaluated at baseline and week 12 after a oral glucose tolerance test with enzymatic-colorimetric techniques
Total Insulin Secretion at Week 12	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
Insulin Sensitivity at Week 12	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
Fasting Glucose Levels at Week 12	Week 12	Fasting glucose will be evaluated at baseline and week 12 with enzymatic-colorimetric techniques
Glycosylated Hemoglobin at Week 12	Week 12	Glycosylated hemoglobin will be evaluated at baseline and week 12 by ELISA
First Phase of Insulin Secretion at Week 12	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

Secondary Outcome Measures

Name	Time	Method
Triglycerides Levels at Week 12	Week 12	Triglycerides levels will be evaluated at baseline and week 12 with enzymatic-colorimetric techniques
Aspartate Aminotransferase (AST) Levels at Week 12	Week 12	AST levels will be evaluated at baseline and week 12 with enzymatic-colorimetric techniques
Alanine Aminotransferase (ALT) Levels at Week 12	Week 12	ALT levels will be evaluated at baseline and week 12 with enzymatic-colorimetric techniques
Body Mass Index at Week 12	Week 12	Body Mass Index will be calculated at baseline and week 12 with the Quetelet index formula
High Density Lipoprotein (c-HDL) Levels at Week 12	Week 12	c-HDL levels will be evaluated at baseline and week 12 with enzymatic-colorimetric techniques
Uric Acid Levels at Week 12	Week 12	Uric acid levels will be evaluated at baseline and week 12 with enzymatic-colorimetric techniques
Systolic Blood Pressure at Week 12	Week 12	Systolic blood pressure will be measured at baseline and week 12 with a digital sphygmomanometer
Weight at Week 12	Week 12	The weight will be measured at baseline and week 12 with a bioimpedance balance
Total Cholesterol at Week 12	Week 12	Total cholesterol levels will be evaluated at baseline and week 12 by enzymatic-colorimetric techniques
Creatinine Levels at Week 12	Week 12	Creatinine levels will be evaluated at baseline and week 12 with enzymatic-colorimetric techniques
Diastolic Blood Pressure at Week 12.	Week 12	Diastolic blood pressure will be measured at baseline and week 12 with a digital sphygmomanometer