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

Study Overview
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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.

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.

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

Conditions
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Glucose Intolerance

Intervention / Treatment
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* Dietary Supplement: Artemisia dracunculus
* Other: Placebo


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Artemisia Dracunculus<br>Artemisia Dracunculus extract, 2 capsules of 500 mg, two times per day before breakfast and dinner during 90 days | Dietary Supplement: Artemisia dracunculus<br> <br> * Other names: estragon, tarragon;|
| Placebo Comparator: Placebo<br>Calcined magnesia, 2 capsules of 500 mg, two times per day before breakfast and dinner during 90 days | Other: Placebo<br> <br> * Other names: calcined magnesia;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Glucose Intolerance, Artemisia dracunculus, Insulin