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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
24
Manuel González Ortiz
Guadalajara, Jalisco, Mexico
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
Time frame: Week 12
Fasting Glucose Levels at Week 12
Fasting glucose will be evaluated at baseline and week 12 with enzymatic-colorimetric techniques
Time frame: Week 12
Glycosylated Hemoglobin at Week 12
Glycosylated hemoglobin will be evaluated at baseline and week 12 by ELISA
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Week 12
Weight at Week 12
The weight will be measured at baseline and week 12 with a bioimpedance balance
Time frame: Week 12
Body Mass Index at Week 12
Body Mass Index will be calculated at baseline and week 12 with the Quetelet index formula
Time frame: Week 12
Total Cholesterol at Week 12
Total cholesterol levels will be evaluated at baseline and week 12 by enzymatic-colorimetric techniques
Time frame: Week 12
Triglycerides Levels at Week 12
Triglycerides levels will be evaluated at baseline and week 12 with enzymatic-colorimetric techniques
Time frame: 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
Time frame: Week 12
Alanine Aminotransferase (ALT) Levels at Week 12
ALT levels will be evaluated at baseline and week 12 with enzymatic-colorimetric techniques
Time frame: Week 12
Aspartate Aminotransferase (AST) Levels at Week 12
AST levels will be evaluated at baseline and week 12 with enzymatic-colorimetric techniques
Time frame: Week 12
Creatinine Levels at Week 12
Creatinine levels will be evaluated at baseline and week 12 with enzymatic-colorimetric techniques
Time frame: Week 12
Uric Acid Levels at Week 12
Uric acid levels will be evaluated at baseline and week 12 with enzymatic-colorimetric techniques
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Time frame: Week 12
Systolic Blood Pressure at Week 12
Systolic blood pressure will be measured at baseline and week 12 with a digital sphygmomanometer
Time frame: Week 12
Diastolic Blood Pressure at Week 12.
Diastolic blood pressure will be measured at baseline and week 12 with a digital sphygmomanometer
Time frame: Week 12