Glucose Intolerance Clinical Trial
Official title:
Effect of Artemisia Dracunculus on Glucose Intolerance, Insulin Sensitivity and Insulin Secretion
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.
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