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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Artemisia Dracunculus | Experimental | Artemisia Dracunculus extract, 2 capsules of 500 mg, two times per day before breakfast and dinner during 90 days |
|
| Placebo | Placebo Comparator | Calcined magnesia, 2 capsules of 500 mg, two times per day before breakfast and dinner during 90 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Artemisia dracunculus | Dietary Supplement |
|
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Fasting Glucose Levels at Week 12 | Fasting glucose will be evaluated at baseline and week 12 with enzymatic-colorimetric techniques | Week 12 |
| Glycosylated Hemoglobin at Week 12 | Glycosylated hemoglobin will be evaluated at baseline and week 12 by ELISA | 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 | 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 | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Weight at Week 12 | The weight will be measured at baseline and week 12 with a bioimpedance balance | Week 12 |
| Body Mass Index at Week 12 | Body Mass Index will be calculated at baseline and week 12 with the Quetelet index formula |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| MANUEL GONZALEZ, PhD | University of Guadalajara | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Manuel González Ortiz | Guadalajara | Jalisco | 44140 | Mexico |
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| ID | Title | Description |
|---|---|---|
| FG000 | Artemisia Dracunculus | Artemisia Dracunculus extract, 2 capsules of 500 mg, two times per day before breakfast and dinner during 90 days Artemisia dracunculus |
| FG001 | Placebo | Calcined magnesia, 2 capsules of 500 mg, two times per day before breakfast and dinner during 90 days Placebo |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Artemisia Dracunculus | Artemisia Dracunculus extract, 2 capsules of 500 mg, two times per day before breakfast and dinner during 90 days Artemisia dracunculus |
| BG001 | Placebo |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | Posted | Mean | Standard Deviation | mmol/L | Week 12 |
|
Adverse events were collected during the 12 weeks of the study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Artemisia Dracunculus | Artemisia Dracunculus extract, 2 capsules of 500 mg, two times per day before breakfast and dinner during 90 days Artemisia dracunculus |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Constipation | Gastrointestinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| DR. MANUEL GONZALEZ ORTIZ | INSTITUTO DE TERAPEUTICA EXPERIMENTAL Y CLINICA, UNIVERSITY OF GUADALAJARA | +52 3310585200 | 34212 | uiec@prodigy.net.mx |
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| ID | Term |
|---|---|
| D018149 | Glucose Intolerance |
| D007333 | Insulin Resistance |
| ID | Term |
|---|---|
| D006943 | Hyperglycemia |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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This is a study with two groups of patients with prediabetes. One group received the investigational product (Artemisia Dracunculus) and the other received placebo as control.
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| Placebo |
| Other |
|
|
| Week 12 |
| Week 12 |
| Total Cholesterol at Week 12 | Total cholesterol levels will be evaluated at baseline and week 12 by enzymatic-colorimetric techniques | Week 12 |
| Triglycerides Levels at Week 12 | Triglycerides levels will be evaluated at baseline and week 12 with enzymatic-colorimetric techniques | 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 | Week 12 |
| Alanine Aminotransferase (ALT) Levels at Week 12 | ALT levels will be evaluated at baseline and week 12 with enzymatic-colorimetric techniques | Week 12 |
| Aspartate Aminotransferase (AST) Levels at Week 12 | AST levels will be evaluated at baseline and week 12 with enzymatic-colorimetric techniques | Week 12 |
| Creatinine Levels at Week 12 | Creatinine levels will be evaluated at baseline and week 12 with enzymatic-colorimetric techniques | Week 12 |
| Uric Acid Levels at Week 12 | Uric acid levels will be evaluated at baseline and week 12 with enzymatic-colorimetric techniques | Week 12 |
| Systolic Blood Pressure at Week 12 | Systolic blood pressure will be measured at baseline and week 12 with a digital sphygmomanometer | Week 12 |
| Diastolic Blood Pressure at Week 12. | Diastolic blood pressure will be measured at baseline and week 12 with a digital sphygmomanometer | Week 12 |
Calcined magnesia, 2 capsules of 500 mg, two times per day before breakfast and dinner during 90 days
Placebo
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Postprandial glucose levels | Mean | Standard Deviation | mmol/L |
|
| Fasting glucose levels | Mean | Standard Deviation | mmol/L |
|
| Glycosylated Hemoglobin | Mean | Standard Deviation | percentage |
|
| First phase of insulin secretion | 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 | Mean | Standard Deviation | index |
|
| Total insulin secretion | 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 | Mean | Standard Deviation | index |
|
| Insulin sensitivity | 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 | Mean | Standard Deviation | index |
|
| Weight | Mean | Standard Deviation | kilograms |
|
| Body Mass Index | Mean | Standard Deviation | kg/m^2 |
|
| Total Cholesterol | Mean | Standard Deviation | mmol/L |
|
| Triglycerides | Mean | Standard Deviation | mmol/L |
|
| High Density Lipoprotein (HDL-c) | Mean | Standard Deviation | mmol/L |
|
| Alanine Aminotransferase (ALT) | Mean | Standard Deviation | U/L |
|
| Aspartate Aminotransferase (AST) | Mean | Standard Deviation | U/L |
|
| Creatinine | Mean | Standard Deviation | umol/L |
|
| Uric Acid | Mean | Standard Deviation | umol/L |
|
| Systolic blood Pressure | Mean | Standard Deviation | mmHg |
|
| Diastolic Blood Pressure | Mean | Standard Deviation | mmHg |
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
| Primary | Fasting Glucose Levels at Week 12 | Fasting glucose will be evaluated at baseline and week 12 with enzymatic-colorimetric techniques | Posted | Mean | Standard Deviation | mmol/L | Week 12 |
|
|
|
|
| Primary | Glycosylated Hemoglobin at Week 12 | Glycosylated hemoglobin will be evaluated at baseline and week 12 by ELISA | Posted | Mean | Standard Deviation | percentage | 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 | Posted | Mean | Standard Deviation | index | 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 (ΔABC insulin/ΔABC glucose), the entered values reflect the total insulin secretion | Posted | Mean | Standard Deviation | index | 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 / √glucose 0' x insulin 0') (mean glucose oral glucose tolerance test (OGTT) x mean insulin OGTT)]. The entered values reflect the insulin sensitivity | Posted | Mean | Standard Deviation | index | Week 12 |
|
|
|
|
| Secondary | Weight at Week 12 | The weight will be measured at baseline and week 12 with a bioimpedance balance | Posted | Mean | Standard Deviation | kilograms | 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 | Posted | Mean | Standard Deviation | kg/m^2 | Week 12 |
|
|
|
|
| Secondary | Total Cholesterol at Week 12 | Total cholesterol levels will be evaluated at baseline and week 12 by enzymatic-colorimetric techniques | Posted | Mean | Standard Deviation | mmol/L | Week 12 |
|
|
|
|
| Secondary | Triglycerides Levels at Week 12 | Triglycerides levels will be evaluated at baseline and week 12 with enzymatic-colorimetric techniques | Posted | Mean | Standard Deviation | mmol/L | 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 | Posted | Mean | Standard Deviation | mmol/L | Week 12 |
|
|
|
|
| Secondary | Alanine Aminotransferase (ALT) Levels at Week 12 | ALT levels will be evaluated at baseline and week 12 with enzymatic-colorimetric techniques | Posted | Mean | Standard Deviation | U/L | Week 12 |
|
|
|
|
| Secondary | Aspartate Aminotransferase (AST) Levels at Week 12 | AST levels will be evaluated at baseline and week 12 with enzymatic-colorimetric techniques | Posted | Mean | Standard Deviation | U/L | Week 12 |
|
|
|
|
| Secondary | Creatinine Levels at Week 12 | Creatinine levels will be evaluated at baseline and week 12 with enzymatic-colorimetric techniques | Posted | Mean | Standard Deviation | umol/L | Week 12 |
|
|
|
|
| Secondary | Uric Acid Levels at Week 12 | Uric acid levels will be evaluated at baseline and week 12 with enzymatic-colorimetric techniques | Posted | Mean | Standard Deviation | umol/L | Week 12 |
|
|
|
|
| Secondary | Systolic Blood Pressure at Week 12 | Systolic blood pressure will be measured at baseline and week 12 with a digital sphygmomanometer | Posted | Mean | Standard Deviation | mmHg | Week 12 |
|
|
|
|
| Secondary | Diastolic Blood Pressure at Week 12. | Diastolic blood pressure will be measured at baseline and week 12 with a digital sphygmomanometer | Posted | Mean | Standard Deviation | mmHg | Week 12 |
|
|
|
|
| 0 |
| 12 |
| 0 |
| 12 |
| 1 |
| 12 |
| EG001 | Placebo | Calcined magnesia, 2 capsules of 500 mg, two times per day before breakfast and dinner during 90 days Placebo | 0 | 12 | 0 | 12 | 2 | 12 |
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| D006946 | Hyperinsulinism |
Results showed in this section are the result of the differences between baseline and final values of fasting glucose on placebo group
| Wilcoxon (Mann-Whitney) |
| 0.910 |
The threshold for statistical significance was p=0.05 |
| Superiority |
Results showed in this section are the result of the differences between baseline and final values of glucosylated hemoglobin on placebo group
| Wilcoxon (Mann-Whitney) |
| 0.938 |
The threshold for statistical significance was p=0.05 |
| Superiority |
Results showed in this section are the result of the differences between baseline and final values of first phase of insulin secretion on placebo group
| Wilcoxon (Mann-Whitney) |
| 1.0 |
The threshold for statistical significance was p=0.05 |
| Superiority |
Results showed in this section are the result of the differences between baseline and final values of total insulin secretion on placebo group
| Wilcoxon (Mann-Whitney) |
| 0.900 |
The threshold for statistical significance was p=0.05 |
| Superiority |
Results showed in this section are the result of the differences between baseline and final values of insulin sensitivity on placebo group
| Wilcoxon (Mann-Whitney) |
| 0.922 |
The threshold for statistical significance was p=0.05 |
| Superiority |
| Wilcoxon (Mann-Whitney) |
| 0.105 |
The threshold for statistical significance was p=0.05 |
| Superiority |
| Wilcoxon (Mann-Whitney) |
| 0.021 |
The threshold for statistical significance was p=0.05 |
| Superiority |
Results showed in this section are the result of the differences between baseline and final values of total cholesterol on placebo group
| Wilcoxon (Mann-Whitney) |
| 0.246 |
The threshold for statistical significance was p=0.05 |
| Superiority |
Results showed in this section are the result of the differences between baseline and final values of triglycerides on placebo group
| Wilcoxon (Mann-Whitney) |
| 0.195 |
The threshold for statistical significance was p=0.05 |
| Superiority |
| Wilcoxon (Mann-Whitney) |
| 1.000 |
The threshold for statistical significance was p=0.05 |
| Superiority |
| Wilcoxon (Mann-Whitney) |
| 0.080 |
The threshold for statistical significance was p=0.05 |
| Superiority |
| Wilcoxon (Mann-Whitney) |
| 0.574 |
The threshold for statistical significance was p=0.05 |
| Superiority |
Results showed in this section are the result of the differences between baseline and final values of creatinine on placebo group
| Wilcoxon (Mann-Whitney) |
| 0.383 |
The threshold for statistical significance was p=0.05 |
| Superiority |
Results showed in this section are the result of the differences between baseline and final values of uric acid on placebo group
| Wilcoxon (Mann-Whitney) |
| 0.080 |
The threshold for statistical significance was p=0.05 |
| Superiority |
Results showed in this section are the result of the differences between baseline and final values of systolic blood pressure on placebo group
| Wilcoxon (Mann-Whitney) |
| 0.082 |
The threshold for statistical significance was p=0.05 |
| Superiority |
Results showed in this section are the result of the differences between baseline and final values of diastolic blood pressure placebo group
| Wilcoxon (Mann-Whitney) |
| 0.199 |
The threshold for statistical significance was p=0.05 |
| Superiority |