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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

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 Summary:

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.


Sponsor: University of Guadalajara

Current Primary Outcome:

  • Postprandial glucose levels at week 12 [ Time Frame: Week 12 ]
    Postprandial glucose will be evaluated at baseline and week 12 after a oral glucose tolerance test with enzymatic-colorimetric techniques
  • Fasting glucose levels at week 12 [ Time Frame: Week 12 ]
    Fasting glucose will be evaluated at baseline and week 12 with enzymatic-colorimetric techniques
  • Glycosylated hemoglobin at week 12 [ Time Frame: Week 12 ]
    Glycosylated hemoglobin will be evaluated at baseline and week 12 by ELISA
  • First phase of insulin secretion at week 12 [ Time Frame: Week 12 ]
    The first phase of insulin secretion will be calculated at baseline and week 12 with Stumvoll index
  • Total insulin secretion at week 12 [ Time Frame: Week 12 ]
    Total insulin secretion will be calculated at baseline and week 12 with insulinogenic index
  • Insulin sensitivity at week 12 [ Time Frame: Week 12 ]
    Insulin sensitivity will be calculated at baseline and week 12 with Matsuda index


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Weight at week 12 [ Time Frame: Week 12 ]
    The weight will be measured at baseline, week 4, week 8 and week 12 with a bioimpedance balance
  • Body Mass Index at week 12 [ Time Frame: Week 12 ]
    Body Mas Index will be calculated at baseline, week 4, week 8 and week 12 with the Quetelet index formula
  • Total cholesterol at week 12 [ Time Frame: Week 12 ]
    Total cholesterol levels will be evaluated at baseline and week 12 by enzymatic-colorimetric techniques
  • Triglycerides levels at week 12 [ Time Frame: Week 12 ]
    Triglycerides levels will be evaluated at baseline and week 12 with enzymatic-colorimetric techniques
  • High density lipoprotien (c-HDL) levels at week 12 [ Time Frame: Week 12 ]
    c-HDL levels will be evaluated at baseline and week 12 with enzymatic-colorimetric techniques
  • Alanine aminotransferase (ALT) levels at week 12 [ Time Frame: Week 12 ]
    ALT levels will be evaluated at baseline and week 12 with enzymatic-colorimetric techniques
  • Aspartate aminotransferase (AST) levels at week 12 [ Time Frame: Week 12 ]
    AST levels will be evaluated at baseline and week 12 with enzymatic-colorimetric techniques
  • Creatinine levels at week 12 [ Time Frame: Week 12 ]
    Creatinine levels will be evaluated at baseline and week 12 with enzymatic-colorimetric techniques
  • Uric acid levels at week 12 [ Time Frame: Week 12 ]
    Uric acid levels will be evaluated at baseline and week 12 with enzymatic-colorimetric techniques
  • Blood pressure at week 12 [ Time Frame: Week 12 ]
    Blood pressure will be measured at baseline and week 12 with a digital sphygmomanometer


Original Secondary Outcome: Same as current

Information By: University of Guadalajara

Dates:
Date Received: December 30, 2014
Date Started: December 2014
Date Completion:
Last Updated: November 30, 2015
Last Verified: November 2015