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Completed

NCT Number: NCT02330341

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.

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Key information

Conditions

Glucose Intolerance Glucose Metabolism Disorders Hyperglycemia Hyperinsulinism Insulin Resistance Metabolic Diseases Nutritional and Metabolic Diseases

Age range

30 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Manuel González Ortiz

Guadalajara, Jalisco, 44140, Mexico

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Artemisia dracunculus

Dietary Supplement

Other names: estragon, tarragon

Placebo

Other

Other names: calcined magnesia

Primary outcomes

  1. 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

  2. Fasting Glucose Levels at Week 12

    Time frame: Week 12

    Fasting glucose will be evaluated at baseline and week 12 with enzymatic-colorimetric techniques

  3. Glycosylated Hemoglobin at Week 12

    Time frame: Week 12

    Glycosylated hemoglobin will be evaluated at baseline and week 12 by ELISA

  4. 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.

    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

  5. Total Insulin Secretion at Week 12

    Time frame: 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

  6. Insulin Sensitivity at Week 12

    Time frame: 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

Secondary outcomes

  1. Weight at Week 12

    Time frame: Week 12

    The weight will be measured at baseline and week 12 with a bioimpedance balance

  2. Body Mass Index at Week 12

    Time frame: Week 12

    Body Mass Index will be calculated at baseline and week 12 with the Quetelet index formula

  3. Total Cholesterol at Week 12

    Time frame: Week 12

    Total cholesterol levels will be evaluated at baseline and week 12 by enzymatic-colorimetric techniques

  4. Triglycerides Levels at Week 12

    Time frame: Week 12

    Triglycerides levels will be evaluated at baseline and week 12 with enzymatic-colorimetric techniques

  5. High Density Lipoprotein (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

  6. 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

  7. 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

  8. Creatinine Levels at Week 12

    Time frame: Week 12

    Creatinine levels will be evaluated at baseline and week 12 with enzymatic-colorimetric techniques

  9. 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

  10. Systolic Blood Pressure at Week 12

    Time frame: Week 12

    Systolic blood pressure will be measured at baseline and week 12 with a digital sphygmomanometer

  11. Diastolic Blood Pressure at Week 12.

    Time frame: Week 12

    Diastolic blood pressure will be measured at baseline and week 12 with a digital sphygmomanometer

Sponsors and collaborators

Lead sponsor

University of Guadalajara

Other

Registry information

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Jan 1, 2015
Registry last updated
Oct 8, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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