Glucose Intolerance
Conditions
Keywords
Glucose Intolerance, Artemisia dracunculus, Insulin
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 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.
Interventions
DIETARY_SUPPLEMENTArtemisia dracunculus
OTHERPlacebo
Sponsors
University of Guadalajara
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
30 Years to 60 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postprandial Glucose Levels at Week 12 | 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 | Week 12 | Fasting glucose will be evaluated at baseline and week 12 with enzymatic-colorimetric techniques |
| Glycosylated Hemoglobin at Week 12 | Week 12 | Glycosylated hemoglobin will be evaluated at baseline and week 12 by ELISA |
| First Phase of Insulin Secretion at Week 12 | 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 |
| Total Insulin Secretion at Week 12 | 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 |
| Insulin Sensitivity at Week 12 | 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
| Measure | Time frame | Description |
|---|---|---|
| Aspartate Aminotransferase (AST) Levels at Week 12 | Week 12 | AST levels will be evaluated at baseline and week 12 with enzymatic-colorimetric techniques |
| Creatinine Levels at Week 12 | Week 12 | Creatinine levels will be evaluated at baseline and week 12 with enzymatic-colorimetric techniques |
| Weight at Week 12 | Week 12 | The weight will be measured at baseline and week 12 with a bioimpedance balance |
| Systolic Blood Pressure at Week 12 | Week 12 | Systolic blood pressure will be measured at baseline and week 12 with a digital sphygmomanometer |
| Diastolic Blood Pressure at Week 12. | Week 12 | Diastolic blood pressure will be measured at baseline and week 12 with a digital sphygmomanometer |
| Uric Acid Levels at Week 12 | Week 12 | Uric acid levels will be evaluated at baseline and week 12 with enzymatic-colorimetric techniques |
| Body Mass Index at Week 12 | Week 12 | Body Mass Index will be calculated at baseline and week 12 with the Quetelet index formula |
| Total Cholesterol at Week 12 | Week 12 | Total cholesterol levels will be evaluated at baseline and week 12 by enzymatic-colorimetric techniques |
| Triglycerides Levels at Week 12 | Week 12 | Triglycerides levels will be evaluated at baseline and week 12 with enzymatic-colorimetric techniques |
| High Density Lipoprotein (c-HDL) Levels at Week 12 | Week 12 | c-HDL levels will be evaluated at baseline and week 12 with enzymatic-colorimetric techniques |
| Alanine Aminotransferase (ALT) Levels at Week 12 | Week 12 | ALT levels will be evaluated at baseline and week 12 with enzymatic-colorimetric techniques |
Countries
Mexico
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Artemisia Dracunculus Artemisia Dracunculus extract, 2 capsules of 500 mg, two times per day before breakfast and dinner during 90 days
Artemisia dracunculus | 12 |
| Placebo Calcined magnesia, 2 capsules of 500 mg, two times per day before breakfast and dinner during 90 days
Placebo | 12 |
| Total | 24 |
Baseline characteristics
| Characteristic | Placebo | Artemisia Dracunculus | Total |
|---|---|---|---|
| Age, Continuous | 48.5 years STANDARD_DEVIATION 7.2 | 48.1 years STANDARD_DEVIATION 7 | 48.3 years STANDARD_DEVIATION 6.9 |
| Alanine Aminotransferase (ALT) | 28.8 U/L STANDARD_DEVIATION 14.1 | 43.8 U/L STANDARD_DEVIATION 25.2 | 36.3 U/L STANDARD_DEVIATION 21.4 |
| Aspartate Aminotransferase (AST) | 26.4 U/L STANDARD_DEVIATION 7.8 | 32.2 U/L STANDARD_DEVIATION 17.7 | 29.3 U/L STANDARD_DEVIATION 11.3 |
| Body Mass Index | 34.1 kg/m^2 STANDARD_DEVIATION 3.2 | 33.1 kg/m^2 STANDARD_DEVIATION 2.9 | 33.6 kg/m^2 STANDARD_DEVIATION 3 |
| Creatinine | 65.4 umol/L STANDARD_DEVIATION 17.7 | 63.7 umol/L STANDARD_DEVIATION 8.8 | 64.6 umol/L STANDARD_DEVIATION 11.5 |
| Diastolic Blood Pressure | 75 mmHg STANDARD_DEVIATION 7 | 78 mmHg STANDARD_DEVIATION 7 | 76.4 mmHg STANDARD_DEVIATION 7.5 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 12 Participants | 12 Participants | 24 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Fasting glucose levels | 5.9 mmol/L STANDARD_DEVIATION 0.9 | 5.5 mmol/L STANDARD_DEVIATION 0.8 | 5.7 mmol/L STANDARD_DEVIATION 0.8 |
| First phase of insulin secretion | 1395 index STANDARD_DEVIATION 1138 | 1057 index STANDARD_DEVIATION 529 | 1226 index STANDARD_DEVIATION 885 |
| Glycosylated Hemoglobin | 5.9 percentage STANDARD_DEVIATION 0.4 | 5.8 percentage STANDARD_DEVIATION 0.3 | 5.8 percentage STANDARD_DEVIATION 0.4 |
| High Density Lipoprotein (HDL-c) | 1.4 mmol/L STANDARD_DEVIATION 0.4 | 1.3 mmol/L STANDARD_DEVIATION 0.3 | 1.3 mmol/L STANDARD_DEVIATION 0.3 |
| Insulin sensitivity | 1.9 index STANDARD_DEVIATION 1.2 | 2.6 index STANDARD_DEVIATION 1.3 | 2.3 index STANDARD_DEVIATION 1.3 |
| Postprandial glucose levels | 9.7 mmol/L STANDARD_DEVIATION 1.1 | 10 mmol/L STANDARD_DEVIATION 1.3 | 9.9 mmol/L STANDARD_DEVIATION 1.2 |
| Region of Enrollment Mexico | 12 participants | 12 participants | 24 participants |
| Sex: Female, Male Female | 11 Participants | 9 Participants | 20 Participants |
| Sex: Female, Male Male | 1 Participants | 3 Participants | 4 Participants |
| Systolic blood Pressure | 123 mmHg STANDARD_DEVIATION 10 | 120 mmHg STANDARD_DEVIATION 11 | 121.6 mmHg STANDARD_DEVIATION 10.8 |
| Total Cholesterol | 5 mmol/L STANDARD_DEVIATION 0.8 | 5.6 mmol/L STANDARD_DEVIATION 1 | 5.3 mmol/L STANDARD_DEVIATION 1 |
| Total insulin secretion | 0.7 index STANDARD_DEVIATION 0.4 | 0.5 index STANDARD_DEVIATION 0.2 | 0.6 index STANDARD_DEVIATION 0.3 |
| Triglycerides | 1.7 mmol/L STANDARD_DEVIATION 0.8 | 2.5 mmol/L STANDARD_DEVIATION 1.5 | 2.2 mmol/L STANDARD_DEVIATION 1.3 |
| Uric Acid | 273.6 umol/L STANDARD_DEVIATION 58.9 | 285.5 umol/L STANDARD_DEVIATION 113 | 279.6 umol/L STANDARD_DEVIATION 132.6 |
| Weight | 83 kilograms STANDARD_DEVIATION 10.2 | 85.3 kilograms STANDARD_DEVIATION 7.7 | 84.1 kilograms STANDARD_DEVIATION 8.9 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 12 | 0 / 12 |
| other Total, other adverse events | 1 / 12 | 2 / 12 |
| serious Total, serious adverse events | 0 / 12 | 0 / 12 |
Outcome results
Primary
Fasting Glucose Levels at Week 12
Fasting glucose will be evaluated at baseline and week 12 with enzymatic-colorimetric techniques
Time frame: Week 12
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Artemisia Dracunculus | Fasting Glucose Levels at Week 12 | 5.9 mmol/L | Standard Deviation 0.6 |
| Placebo | Fasting Glucose Levels at Week 12 | 5.9 mmol/L | Standard Deviation 0.6 |
Comparison: Results showed in this section are the result of the differences between baseline and final values of fasting glucose on Artemisia Dracunculus groupp-value: 0.11Wilcoxon (Mann-Whitney)
Comparison: Results showed in this section are the result of the differences between baseline and final values of fasting glucose on placebo groupp-value: 0.91Wilcoxon (Mann-Whitney)
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
Time frame: Week 12
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Artemisia Dracunculus | First Phase of Insulin Secretion at Week 12 | 1235 index | Standard Deviation 1047 |
| Placebo | First Phase of Insulin Secretion at Week 12 | 1566 index | Standard Deviation 1206 |
Comparison: Results showed in this section are the result of the differences between baseline and final values of first phase of insulin secretion on Artemisia Dracunculus groupp-value: 0.733Wilcoxon (Mann-Whitney)
Comparison: Results showed in this section are the result of the differences between baseline and final values of first phase of insulin secretion on placebo groupp-value: 1Wilcoxon (Mann-Whitney)
Primary
Glycosylated Hemoglobin at Week 12
Glycosylated hemoglobin will be evaluated at baseline and week 12 by ELISA
Time frame: Week 12
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Artemisia Dracunculus | Glycosylated Hemoglobin at Week 12 | 5.6 percentage | Standard Deviation 0.4 |
| Placebo | Glycosylated Hemoglobin at Week 12 | 5.8 percentage | Standard Deviation 0.4 |
Comparison: Results showed in this section are the result of the differences between baseline and final values of glucosylated hemoglobin on Artemisia Dracunculus groupp-value: 0.01Wilcoxon (Mann-Whitney)
Comparison: Results showed in this section are the result of the differences between baseline and final values of glucosylated hemoglobin on placebo groupp-value: 0.938Wilcoxon (Mann-Whitney)
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
Time frame: Week 12
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Artemisia Dracunculus | Insulin Sensitivity at Week 12 | 2.4 index | Standard Deviation 1 |
| Placebo | Insulin Sensitivity at Week 12 | 1.8 index | Standard Deviation 0.9 |
Comparison: Results showed in this section are the result of the differences between baseline and final values of insulin sensitivity on Artemisia Dracunculus groupp-value: 0.519Wilcoxon (Mann-Whitney)
Comparison: Results showed in this section are the result of the differences between baseline and final values of insulin sensitivity on placebo groupp-value: 0.922Wilcoxon (Mann-Whitney)
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
Time frame: Week 12
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Artemisia Dracunculus | Postprandial Glucose Levels at Week 12 | 9.5 mmol/L | Standard Deviation 1.8 |
| Placebo | Postprandial Glucose Levels at Week 12 | 9.9 mmol/L | Standard Deviation 2.5 |
Comparison: Results showed in this section are the result of the differences between baseline and final values of postprandial glucose on Artemisia Dracunculus groupp-value: 0.38Wilcoxon (Mann-Whitney)
Comparison: Results showed in this section are the result of the differences between baseline and final values of postprandial glucose on placebo groupp-value: 0.695Wilcoxon (Mann-Whitney)
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
Time frame: Week 12
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Artemisia Dracunculus | Total Insulin Secretion at Week 12 | 0.35 index | Standard Deviation 0.2 |
| Placebo | Total Insulin Secretion at Week 12 | 0.75 index | Standard Deviation 0.4 |
Comparison: Results showed in this section are the result of the differences between baseline and final values of total insulin secretion on Artemisia Dracunculus groupp-value: 0.03Wilcoxon (Mann-Whitney)
Comparison: Results showed in this section are the result of the differences between baseline and final values of total insulin secretion on placebo groupp-value: 0.9Wilcoxon (Mann-Whitney)
Secondary
Alanine Aminotransferase (ALT) Levels at Week 12
ALT levels will be evaluated at baseline and week 12 with enzymatic-colorimetric techniques
Time frame: Week 12
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Artemisia Dracunculus | Alanine Aminotransferase (ALT) Levels at Week 12 | 32.8 U/L | Standard Deviation 17.7 |
| Placebo | Alanine Aminotransferase (ALT) Levels at Week 12 | 36.7 U/L | Standard Deviation 18.2 |
Comparison: Results showed in this section are the result of the differences between baseline and final values of ALT on Artemisia Dracunculus groupp-value: 0.021Wilcoxon (Mann-Whitney)
Comparison: Results showed in this section are the result of the differences between baseline and final values of ALT on placebo groupp-value: 0.08Wilcoxon (Mann-Whitney)
Secondary
Aspartate Aminotransferase (AST) Levels at Week 12
AST levels will be evaluated at baseline and week 12 with enzymatic-colorimetric techniques
Time frame: Week 12
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Artemisia Dracunculus | Aspartate Aminotransferase (AST) Levels at Week 12 | 30.3 U/L | Standard Deviation 18.1 |
| Placebo | Aspartate Aminotransferase (AST) Levels at Week 12 | 26.7 U/L | Standard Deviation 9.8 |
Comparison: Results showed in this section are the result of the differences between baseline and final values of AST on Artemisia Dracunculus groupp-value: 0.465Wilcoxon (Mann-Whitney)
Comparison: Results showed in this section are the result of the differences between baseline and final values of AST on placebo groupp-value: 0.574Wilcoxon (Mann-Whitney)
Secondary
Body Mass Index at Week 12
Body Mass Index will be calculated at baseline and week 12 with the Quetelet index formula
Time frame: Week 12
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Artemisia Dracunculus | Body Mass Index at Week 12 | 33.2 kg/m^2 | Standard Deviation 2.9 |
| Placebo | Body Mass Index at Week 12 | 34.4 kg/m^2 | Standard Deviation 3.3 |
Comparison: Results showed in this section are the result of the differences between baseline and final values of BMI on Artemisia Dracunculus groupp-value: 0.687Wilcoxon (Mann-Whitney)
Comparison: Results showed in this section are the result of the differences between baseline and final values of BMI on placebo groupp-value: 0.021Wilcoxon (Mann-Whitney)
Secondary
Creatinine Levels at Week 12
Creatinine levels will be evaluated at baseline and week 12 with enzymatic-colorimetric techniques
Time frame: Week 12
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Artemisia Dracunculus | Creatinine Levels at Week 12 | 61.01 umol/L | Standard Deviation 16.8 |
| Placebo | Creatinine Levels at Week 12 | 61.01 umol/L | Standard Deviation 13.3 |
Comparison: Results showed in this section are the result of the differences between baseline and final values of creatinine on Artemisia Dracunculus groupp-value: 0.48Wilcoxon (Mann-Whitney)
Comparison: Results showed in this section are the result of the differences between baseline and final values of creatinine on placebo groupp-value: 0.383Wilcoxon (Mann-Whitney)
Secondary
Diastolic Blood Pressure at Week 12.
Diastolic blood pressure will be measured at baseline and week 12 with a digital sphygmomanometer
Time frame: Week 12
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Artemisia Dracunculus | Diastolic Blood Pressure at Week 12. | 75 mmHg | Standard Deviation 8 |
| Placebo | Diastolic Blood Pressure at Week 12. | 79 mmHg | Standard Deviation 9 |
Comparison: Results showed in this section are the result of the differences between baseline and final values of diastolic blood pressure on Artemisia Dracunculus groupp-value: 0.17Wilcoxon (Mann-Whitney)
Comparison: Results showed in this section are the result of the differences between baseline and final values of diastolic blood pressure placebo groupp-value: 0.199Wilcoxon (Mann-Whitney)
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
Time frame: Week 12
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Artemisia Dracunculus | High Density Lipoprotein (c-HDL) Levels at Week 12 | 1.4 mmol/L | Standard Deviation 0.3 |
| Placebo | High Density Lipoprotein (c-HDL) Levels at Week 12 | 1.3 mmol/L | Standard Deviation 0.4 |
Comparison: Results showed in this section are the result of the differences between baseline and final values of HDL-c on Artemisia Dracunculus groupp-value: 0.04Wilcoxon (Mann-Whitney)
Comparison: Results showed in this section are the result of the differences between baseline and final values of HDL-c on placebo groupp-value: 1Wilcoxon (Mann-Whitney)
Secondary
Systolic Blood Pressure at Week 12
Systolic blood pressure will be measured at baseline and week 12 with a digital sphygmomanometer
Time frame: Week 12
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Artemisia Dracunculus | Systolic Blood Pressure at Week 12 | 113 mmHg | Standard Deviation 11 |
| Placebo | Systolic Blood Pressure at Week 12 | 125 mmHg | Standard Deviation 8 |
Comparison: Results showed in this section are the result of the differences between baseline and final values of systolic blood pressure on Artemisia Dracunculus groupp-value: 0.017Wilcoxon (Mann-Whitney)
Comparison: Results showed in this section are the result of the differences between baseline and final values of systolic blood pressure on placebo groupp-value: 0.082Wilcoxon (Mann-Whitney)
Secondary
Total Cholesterol at Week 12
Total cholesterol levels will be evaluated at baseline and week 12 by enzymatic-colorimetric techniques
Time frame: Week 12
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Artemisia Dracunculus | Total Cholesterol at Week 12 | 5.4 mmol/L | Standard Deviation 1.2 |
| Placebo | Total Cholesterol at Week 12 | 5.0 mmol/L | Standard Deviation 0.8 |
Comparison: Results showed in this section are the result of the differences between baseline and final values of total cholesterol on Artemisia Dracunculus groupp-value: 0.339Wilcoxon (Mann-Whitney)
Comparison: Results showed in this section are the result of the differences between baseline and final values of total cholesterol on placebo groupp-value: 0.246Wilcoxon (Mann-Whitney)
Secondary
Triglycerides Levels at Week 12
Triglycerides levels will be evaluated at baseline and week 12 with enzymatic-colorimetric techniques
Time frame: Week 12
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Artemisia Dracunculus | Triglycerides Levels at Week 12 | 2.2 mmol/L | Standard Deviation 0.7 |
| Placebo | Triglycerides Levels at Week 12 | 1.8 mmol/L | Standard Deviation 0.9 |
Comparison: Results showed in this section are the result of the differences between baseline and final values of triglycerides on Artemisia Dracunculus groupp-value: 0.775Wilcoxon (Mann-Whitney)
Comparison: Results showed in this section are the result of the differences between baseline and final values of triglycerides on placebo groupp-value: 0.195Wilcoxon (Mann-Whitney)
Secondary
Uric Acid Levels at Week 12
Uric acid levels will be evaluated at baseline and week 12 with enzymatic-colorimetric techniques
Time frame: Week 12
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Artemisia Dracunculus | Uric Acid Levels at Week 12 | 350.9 umol/L | Standard Deviation 71.4 |
| Placebo | Uric Acid Levels at Week 12 | 309.3 umol/L | Standard Deviation 50.6 |
Comparison: Results showed in this section are the result of the differences between baseline and final values of uric acid on Artemisia Dracunculus groupp-value: 0.034Wilcoxon (Mann-Whitney)
Comparison: Results showed in this section are the result of the differences between baseline and final values of uric acid on placebo groupp-value: 0.08Wilcoxon (Mann-Whitney)
Secondary
Weight at Week 12
The weight will be measured at baseline and week 12 with a bioimpedance balance
Time frame: Week 12
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Artemisia Dracunculus | Weight at Week 12 | 85.3 kilograms | Standard Deviation 8.2 |
| Placebo | Weight at Week 12 | 84.0 kilograms | Standard Deviation 11 |
Comparison: Results showed in this section are the result of the differences between baseline and final values of weight on Artemisia Dracunculus groupp-value: 0.605Wilcoxon (Mann-Whitney)
Comparison: Results showed in this section are the result of the differences between baseline and final values of weight on placebo groupp-value: 0.105Wilcoxon (Mann-Whitney)