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

Glucose Intolerance Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02330341
• Other study ID #: GI-ESTRAGON
• Status: Completed
• Phase: N/A
• Start date: December 2014
• Est. completion date: July 2015

Study information

• Verified date: September 2020
• Source: University of Guadalajara
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: July 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Glucose Intolerance
• Insulin Resistance

Intervention

Dietary Supplement:
• Artemisia dracunculus

Other:
• Placebo

Locations

Country	Name	City	State
Mexico	Manuel González Ortiz	Guadalajara	Jalisco

Sponsors (1)

Lead Sponsor	Collaborator
University of Guadalajara

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Fasting Glucose Levels at Week 12	Fasting glucose will be evaluated at baseline and week 12 with enzymatic-colorimetric techniques	Week 12
Primary	Glycosylated Hemoglobin at Week 12	Glycosylated hemoglobin will be evaluated at baseline and week 12 by ELISA	Week 12
Primary	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
Primary	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 (?ABC insulin/?ABC glucose), the entered values reflect the total insulin secretion	Week 12
Primary	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 / vglucose 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	Weight at Week 12	The weight will be measured at baseline and week 12 with a bioimpedance balance	Week 12
Secondary	Body Mass Index at Week 12	Body Mass Index will be calculated at baseline and week 12 with the Quetelet index formula	Week 12
Secondary	Total Cholesterol at Week 12	Total cholesterol levels will be evaluated at baseline and week 12 by enzymatic-colorimetric techniques	Week 12
Secondary	Triglycerides Levels at Week 12	Triglycerides levels will be evaluated at baseline and week 12 with enzymatic-colorimetric techniques	Week 12
Secondary	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
Secondary	Alanine Aminotransferase (ALT) Levels at Week 12	ALT levels will be evaluated at baseline and week 12 with enzymatic-colorimetric techniques	Week 12
Secondary	Aspartate Aminotransferase (AST) Levels at Week 12	AST levels will be evaluated at baseline and week 12 with enzymatic-colorimetric techniques	Week 12
Secondary	Creatinine Levels at Week 12	Creatinine levels will be evaluated at baseline and week 12 with enzymatic-colorimetric techniques	Week 12
Secondary	Uric Acid Levels at Week 12	Uric acid levels will be evaluated at baseline and week 12 with enzymatic-colorimetric techniques	Week 12
Secondary	Systolic Blood Pressure at Week 12	Systolic blood pressure will be measured at baseline and week 12 with a digital sphygmomanometer	Week 12
Secondary	Diastolic Blood Pressure at Week 12.	Diastolic blood pressure will be measured at baseline and week 12 with a digital sphygmomanometer	Week 12