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The aim of this study was to evaluate the effect of propolis or metformin on glycemic control in patients with type 2 diabetes mellitus without pharmacological treatment.
All patients received for 12 weeks propolis, metformin or placebo. Fasting serum glucose, 2-h serum glucose after oral glucose tolerance test, glycated hemoglobin A1c, a metabolic profile, areas under the curve of glucose and insulin, insulinogenic index, Stumvoll index, and Matsuda index were measured.
A randomized, double-blind, placebo-controlled clinical trial of three pharmacological groups was carried out, with the participation of 36 patients with type 2 Diabetes Mellitus without pharmacological treatment.
At the beginning and end of the study, fasting serum glucose, 2-h serum glucose after oral glucose tolerance test, glycated hemoglobin A1c, and a metabolic profile were measured. Areas under the curve of glucose and insulin, total insulin secretion insulinogenic index), the first phase of insulin secretion (Stumvoll index), and insulin sensitivity (Matsuda index) were calculated.
All patients received for 12 weeks two capsules a day, one before the first bite of breakfast and another before the first bite of dinner. 12 of them took propolis (300 mg), another 12 received metformin (850 mg), and 12 more placebo in the same pharmacological presentation.
This protocol was approved by a local ethics committee and written informed consent was obtained from all volunteers.
Results are presented as mean and standard deviation. Intra-group differences were evaluated using Kruskal-Wallis and Mann-Whitney U-tests, while inter-group differences were calculated with the Wilcoxon test; p≤0.05 was considered significant.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Propolis | Experimental | Propolis capsules, 300 mg, two times per day before break-fast and dinner during 12 weeks. |
|
| Metformin | Experimental | Metformin capsules, 850 mg, two times per day before break-fast and dinner during 12 weeks. |
|
| Placebo | Placebo Comparator | Placebo capsules, two times per day before break-fast and dinner during 12 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Propolis | Drug | Propolis capsules, 300 mg, two times per day before break-fast and dinner during 12 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Fasting Serum Glucose | The fasting glucose levels were evaluated at week 12 with enzymatic/colorimetric techniques and the entered values reflect the fasting glucose level at week 12 | Week 12 |
| 2 Hours After Oral Glucose Tolerance Test in Week 12 | 2-h serum glucose levels were evaluated at week 12 after a oral glucose tolerance test with enzymatic/colorimetric techniques and the entered values reflect the insulin sensitivity at week 12 | Week 12 |
| Glycosylated Hemoglobin (A1C) | Glycosylated hemoglobin was evaluated at week 12 by high pressure liquid chromatography (HPLC) and the entered values reflect the glycosylated hemoglobin at week 12 | Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Total Insulin Secretion | Total insulin secretion was calculated at week 12 with insulinogenic index and the entered values reflect the total insulin secretion at week 12. 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 (ΔAUC insulin/ΔAUC glucose), the entered values reflect the total insulin secretion |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| MANUEL GONZALEZ, PhD | Intstituto de Terapeútica Experimental y Clínica. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Intstituto de Terapeútica Experimental y Clínica. Centro Universitario de Ciencias de la Salud. Universidad de Guadalajara | Guadalajara | Jalisco | 44340 | Mexico |
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| ID | Title | Description |
|---|---|---|
| FG000 | Propolis | Propolis capsules, 300 mg, two times per day before break-fast and dinner during 12 weeks. Propolis: Propolis capsules, 300 mg, two times per day before break-fast and dinner during 12 weeks. |
| FG001 | Metformin | Metformin capsules, 850 mg, two times per day before break-fast and dinner during 12 weeks. Metformin: Metformin capsules, 850 mg, two times per day before break-fast and dinner during 12 weeks. |
| FG002 | Placebo | Placebo capsules, two times per day before break-fast and dinner during 12 weeks. Placebo: Calcined magnesium, two times per day before break-fast and dinner during 12 weeks. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Propolis | Propolis capsules, 300 mg, two times per day before break-fast and dinner during 12 weeks. Propolis: Propolis capsules, 300 mg, two times per day before break-fast and dinner during 12 weeks. |
| BG001 | Metformin |
| 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 | Fasting Serum Glucose | The fasting glucose levels were evaluated at week 12 with enzymatic/colorimetric techniques and the entered values reflect the fasting glucose level at week 12 | Two of the study groups have one less patient due to withdrawal by subject, as mentioned in the participant flow, so the analysis of this outcome is calculated with those who finished the intervention | Posted | Mean | Standard Deviation | mmol/L | Week 12 |
|
Throughout the study, an average of 12 weeks
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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 | Propolis | Propolis capsules, 300 mg, two times per day before break-fast and dinner during 12 weeks. Propolis: Propolis capsules, 300 mg, two times per day before break-fast and dinner during 12 weeks. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhea | Gastrointestinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| DR. MANUEL GONZALEZ ORTIZ | INSTITUTO DE TERAPEUTICA EXPERIMENTAL Y CLINICA | +52 3310585200 | 34212 | uiec@prodigy.net.mx |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 6, 2017 | Sep 16, 2020 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Apr 6, 2017 | Sep 16, 2020 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D011429 | Propolis |
| D008687 | Metformin |
| ID | Term |
|---|---|
| D012116 | Resins, Plant |
| D001704 | Biopolymers |
| D011108 | Polymers |
| D046911 | Macromolecular Substances |
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| Metformin | Drug | Metformin capsules, 850 mg, two times per day before break-fast and dinner during 12 weeks. |
|
|
| Placebo | Drug | Calcined magnesium, two times per day before break-fast and dinner during 12 weeks. |
|
|
| Week 12 |
| Insulin Sensitivity | Insulin sensitivity was calculated at week 12 with Matsuda index and the entered values reflect the insulin sensitivity at week 12. 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 | Week 12 |
| First Phase of Insulin Secretion | The first phase of insulin secretion was calculated at week 12 with Stumvoll index and the entered values reflect the frst phase of insulin secretion at week 12. 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 |
| AUC Glucose | Area under the curve (AUC) of glucose was calculated with the polygonal formula. The area under the curve (AUC) of glucose, (0.5 * glucose (G) 0´ + (G 30´+G 60´ + G 90´) + 0.5 * G 120´) * 30; has been widely used for calculating the glycemic index and for evaluating the efficacy of medications for postprandial hyperglycemia. | Week 12 |
| AUC Insulin | Area under the curve (AUC) of insulin was calculated with the polygonal formula. The area under the curve (AUC) of insulin, (0.5 * Insulin (I) 0´ + (I 30´+I 60´ + I 90´) + 0.5 * I 120´) * 30; has been widely used for calculating the glycemic index and for evaluating the efficacy of medications for postprandial hyperinsulinemia. | Week 12 |
| Glucose 30 Min After Oral Glucose Tolerance Test at 12 Week | The glucose levels 30' were evaluated at week 12 with enzymatic/colorimetric techniques and the entered values reflect the glucose 30' at week 12 | Week 12 |
| Glucose 60 Min After Oral Glucose Tolerance Test at 12 Week | The glucose levels 60' were evaluated at week 12 with enzymatic/colorimetric techniques and the entered values reflect the glucose 60' at week 12 | Week 12 |
| Glucose 90 Min After Oral Glucose Tolerance Test at 12 Week | The glucose levels 90' were evaluated at week 12 with enzymatic/colorimetric techniques and the entered values reflect the glucose 90' at week 12. | Week 12 |
| Waist Circumference | Waist circumference was evaluated at week 12 with a flexible tape | Week 12 |
| Body Weight | The body weight was measured at week 12 with a bioimpedance balance and the entered values reflect the body weight at week 12 | Week 12 |
| Body Mass Index | Body Mas Index was calculated at week 12 with the Quetelet index formula and the entered values reflect the body mass index at week 12 | Week 12 |
| Percentage of Fat Mass | Percentage of fat mass was evaluated through bioimpedance. | Week 12 |
| Total Cholesterol | Total cholesterol levels were evaluated at week 12 by enzymatic/colorimetric techniques and the entered values reflect the total cholesterol level at week 12 | Week 12 |
| Triglycerides | Triglycerides levels were evaluated at week 12 with enzymatic/colorimetric techniques and the entered values reflect the triglycerides level at week 12 | Week 12 |
| High Density Lipoprotein Cholesterol (c-HDL) | c-HDL levels were evaluated at week 12 with enzymatic/colorimetric techniques and the entered values reflect the c-HDL level at week 12 | Week 12 |
| Low Density Lipoproteins Cholesterol (c-LDL) | c-LDL levels were evaluated at week 12 with enzymatic/colorimetric techniques and the entered values reflect the c-LDL level at week 12 | Week 12 |
| Very Low Density Lipoprotein (c-VLDL) | Very low density lipoprotein (c-VLDL) was analyzed with the cholesterol oxidase/peroxidase technique by enzymatic colorimetric methods on an automatic analyzer. | Week 12 |
| Creatinine | Creatinine levels were evaluated at week 12 with enzymatic/colorimetric techniques | Week 12 |
| Uric Acid | Uric acid levels were evaluated at week 12 with enzymatic/colorimetric techniques | Week 12 |
| Systolic Blood Pressure | The systolic blood pressure was evaluated at week 12 with a digital sphygmomanometer and the entered values reflect the systolic blood pressure at week 12. | Week 12 |
| Diastolic Blood Pressure | The diastolic blood pressure was evaluated at week 12 with a digital sphygmomanometer and the entered values reflect the diastolic blood pressure at week 12. | Week 12 |
Metformin capsules, 850 mg, two times per day before break-fast and dinner during 12 weeks.
Metformin: Metformin capsules, 850 mg, two times per day before break-fast and dinner during 12 weeks.
| BG002 | Placebo | Placebo capsules, two times per day before break-fast and dinner during 12 weeks. Placebo: Calcined magnesium, two times per day before break-fast and dinner during 12 weeks. |
| BG003 | 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 |
|
| Fasting serum glucose | Fasting serum glucose was analyzed with the glucose oxidase/peroxidase technique by enzymatic colorimetric methods on an automatic analyzer. | Mean | Standard Deviation | mmol/L |
|
| 2 hours after OGTT | 2-h serum glucose was analyzed with the glucose oxidase/peroxidase technique by enzymatic colorimetric methods on an automatic analyzer. | Mean | Standard Deviation | mmol/L |
|
| Glycosylated Hemoglobin (A1C) | Glycosylated Hemoglobin (A1C) was evaluated with liquid chromatography method. | Mean | Standard Deviation | percentage |
|
| 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 (ΔAUC insulin/ΔAUC 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 |
|
| 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 |
|
| AUC glucose | Area under the curve (AUC) of glucose and insulin was calculated with the polygonal formula. | Mean | Standard Deviation | mmol*min/L |
|
| AUC insulin | Area under the curve (AUC) of glucose and insulin was calculated with the polygonal formula. | Mean | Standard Deviation | pmol*min/L |
|
| Glucose 30 min after oral glucose tolerance test | Glucose 30' was analyzed with the glucose oxidase/peroxidase technique by enzymatic colorimetric methods on an automatic analyzer. | Mean | Standard Deviation | mmol/L |
|
| Glucose 60 min after oral glucose tolerance test | Glucose 60' was analyzed with the glucose oxidase/peroxidase technique by enzymatic colorimetric methods on an automatic analyzer. | Mean | Standard Deviation | mmol/L |
|
| Glucose 90 min after oral glucose tolerance test | Glucose 90' was analyzed with the glucose oxidase/peroxidase technique by enzymatic colorimetric methods on an automatic analyzer. | Mean | Standard Deviation | mmol/L |
|
| Waist circumference | Waist circumference was measured with a flexible tape in the midpoint between the lowest rib and the iliac crest and is expressed in centimeters. | Mean | Standard Deviation | cm |
|
| Body weight | Body weight was evaluated through a bioimpedance digital scale and results are reported in kg with a decimal. | Mean | Standard Deviation | kg |
|
| Body mass index | Body mass index was calculated as weight (kg) divided by height (m2). | Mean | Standard Deviation | kg/m^2 |
|
| Percentage of fat mass | Percentage of fat mass was evaluated through bioimpedance. | Mean | Standard Deviation | % fat mass |
|
| Total cholesterol | Total cholesterol was analyzed with the cholesterol oxidase/peroxidase technique by enzymatic colorimetric methods on an automatic analyzer. | Mean | Standard Deviation | mmol/L |
|
| Triglycerides | Triglycerides were analyzed with the triglycerides oxidase/peroxidase technique by enzymatic colorimetric methods on an automatic analyzer. | Mean | Standard Deviation | mmol/L |
|
| High Density Lipoprotein cholesterol (c-HDL) | High-density lipoprotein cholesterol (c-HDL) was analyzed with the cholesterol oxidase/peroxidase technique by enzymatic colorimetric methods on an automatic analyzer. | Mean | Standard Deviation | mmol/L |
|
| Low-Density Lipoproteins-cholesterol (c-LDL) | Low-density lipoprotein-cholesterol (c-LDL) was calculated with the Friedewald formula as follows: LDL-c (mmol/L)= TC (mmol/L) - HDL-c (mmol/L) - [TG(mmol/L)/2.2] | Mean | Standard Deviation | mmol/L |
|
| Very low density lipoprotein (VLDL) | Very low density cholesterol (c-VLDL) was analyzed with the cholesterol oxidase/peroxidase technique by enzymatic colorimetric methods on an automatic analyzer. | Mean | Standard Deviation | mmol/L |
|
| Creatinine | Creatinine was analyzed with the alkaline picrate technique by enzymatic colorimetric methods on an automatic analyzer. | Mean | Standard Deviation | mmol/L |
|
| Uric acid | Uric acid was analyzed with the uric acid oxidase/peroxidase technique by enzymatic colorimetric methods on an automatic analyzer. | Mean | Standard Deviation | mmol/L |
|
| Systolic blood pressure | Blood pressure was evaluated with a digital sphygmomanometer with the subject sited down on a chair after a resting period of 5 minutes on three occasions. The mean of the three measures was considered as the value of systolic blood pressure (SBP) and diastolic (DBP). | Mean | Standard Deviation | mmHg |
|
| Diastolic blood pressure | Blood pressure was evaluated with a digital sphygmomanometer with the subject sited down on a chair after a resting period of 5 minutes on three occasions. The mean of the three measures was considered as the value of systolic blood pressure (SBP) and diastolic (DBP). | Mean | Standard Deviation | mmHg |
|
Metformin capsules, 850 mg, two times per day before break-fast and dinner during 12 weeks.
Metformin: Metformin capsules, 850 mg, two times per day before break-fast and dinner during 12 weeks.
| OG002 | Placebo | Placebo capsules, two times per day before break-fast and dinner during 12 weeks. Placebo: Calcined magnesium, two times per day before break-fast and dinner during 12 weeks. |
|
|
|
| Primary | 2 Hours After Oral Glucose Tolerance Test in Week 12 | 2-h serum glucose levels were evaluated at week 12 after a oral glucose tolerance test with enzymatic/colorimetric techniques and the entered values reflect the insulin sensitivity at week 12 | Two of the study groups have one less patient due to withdrawal by subject, as mentioned in the participant flow, so the analysis of this outcome is calculated with those who finished the intervention | Posted | Mean | Standard Deviation | mmol/L | Week 12 |
|
|
|
|
| Primary | Glycosylated Hemoglobin (A1C) | Glycosylated hemoglobin was evaluated at week 12 by high pressure liquid chromatography (HPLC) and the entered values reflect the glycosylated hemoglobin at week 12 | Two of the study groups have one less patient due to withdrawal by subject, as mentioned in the participant flow, so the analysis of this outcome is calculated with those who finished the intervention | Posted | Mean | Standard Deviation | % of A1C | Week 12 |
|
|
|
|
| Secondary | Total Insulin Secretion | Total insulin secretion was calculated at week 12 with insulinogenic index and the entered values reflect the total insulin secretion at week 12. 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 (ΔAUC insulin/ΔAUC glucose), the entered values reflect the total insulin secretion | Two of the study groups have one less patient due to withdrawal by subject, as mentioned in the participant flow, so the analysis of this outcome is calculated with those who finished the intervention | Posted | Mean | Standard Deviation | index | Week 12 |
|
|
|
|
| Secondary | Insulin Sensitivity | Insulin sensitivity was calculated at week 12 with Matsuda index and the entered values reflect the insulin sensitivity at week 12. 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 | Two of the study groups have one less patient due to withdrawal by subject, as mentioned in the participant flow, so the analysis of this outcome is calculated with those who finished the intervention | Posted | Mean | Standard Deviation | index | Week 12 |
|
|
|
|
| Secondary | First Phase of Insulin Secretion | The first phase of insulin secretion was calculated at week 12 with Stumvoll index and the entered values reflect the frst phase of insulin secretion at week 12. 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 | Two of the study groups have one less patient due to withdrawal by subject, as mentioned in the participant flow, so the analysis of this outcome is calculated with those who finished the intervention | Posted | Mean | Standard Deviation | index | Week 12 |
|
|
|
|
| Secondary | AUC Glucose | Area under the curve (AUC) of glucose was calculated with the polygonal formula. The area under the curve (AUC) of glucose, (0.5 * glucose (G) 0´ + (G 30´+G 60´ + G 90´) + 0.5 * G 120´) * 30; has been widely used for calculating the glycemic index and for evaluating the efficacy of medications for postprandial hyperglycemia. | Two of the study groups have one less patient due to withdrawal by subject, as mentioned in the participant flow, so the analysis of this outcome is calculated with those who finished the intervention | Posted | Mean | Standard Deviation | mmol*min/L | Week 12 |
|
|
|
|
| Secondary | AUC Insulin | Area under the curve (AUC) of insulin was calculated with the polygonal formula. The area under the curve (AUC) of insulin, (0.5 * Insulin (I) 0´ + (I 30´+I 60´ + I 90´) + 0.5 * I 120´) * 30; has been widely used for calculating the glycemic index and for evaluating the efficacy of medications for postprandial hyperinsulinemia. | Two of the study groups have one less patient due to withdrawal by subject, as mentioned in the participant flow, so the analysis of this outcome is calculated with those who finished the intervention | Posted | Mean | Standard Deviation | pmol*min/L | Week 12 |
|
|
|
|
| Secondary | Glucose 30 Min After Oral Glucose Tolerance Test at 12 Week | The glucose levels 30' were evaluated at week 12 with enzymatic/colorimetric techniques and the entered values reflect the glucose 30' at week 12 | Two of the study groups have one less patient due to withdrawal by subject, as mentioned in the participant flow, so the analysis of this outcome is calculated with those who finished the intervention | Posted | Mean | Standard Deviation | mmol/L | Week 12 |
|
|
|
|
| Secondary | Glucose 60 Min After Oral Glucose Tolerance Test at 12 Week | The glucose levels 60' were evaluated at week 12 with enzymatic/colorimetric techniques and the entered values reflect the glucose 60' at week 12 | Two of the study groups have one less patient due to withdrawal by subject, as mentioned in the participant flow, so the analysis of this outcome is calculated with those who finished the intervention | Posted | Mean | Standard Deviation | mmol/L | Week 12 |
|
|
|
|
| Secondary | Glucose 90 Min After Oral Glucose Tolerance Test at 12 Week | The glucose levels 90' were evaluated at week 12 with enzymatic/colorimetric techniques and the entered values reflect the glucose 90' at week 12. | Two of the study groups have one less patient due to withdrawal by subject, as mentioned in the participant flow, so the analysis of this outcome is calculated with those who finished the intervention | Posted | Mean | Standard Deviation | mmol/L | Week 12 |
|
|
|
|
| Secondary | Waist Circumference | Waist circumference was evaluated at week 12 with a flexible tape | Two of the study groups have one less patient due to withdrawal by subject, as mentioned in the participant flow, so the analysis of this outcome is calculated with those who finished the intervention | Posted | Mean | Standard Deviation | cm | Week 12 |
|
|
|
|
| Secondary | Body Weight | The body weight was measured at week 12 with a bioimpedance balance and the entered values reflect the body weight at week 12 | Two of the study groups have one less patient due to withdrawal by subject, as mentioned in the participant flow, so the analysis of this outcome is calculated with those who finished the intervention | Posted | Mean | Standard Deviation | kg | Week 12 |
|
|
|
|
| Secondary | Body Mass Index | Body Mas Index was calculated at week 12 with the Quetelet index formula and the entered values reflect the body mass index at week 12 | Two of the study groups have one less patient due to withdrawal by subject, as mentioned in the participant flow, so the analysis of this outcome is calculated with those who finished the intervention | Posted | Mean | Standard Deviation | kg/m2 | Week 12 |
|
|
|
|
| Secondary | Percentage of Fat Mass | Percentage of fat mass was evaluated through bioimpedance. | Two of the study groups have one less patient due to withdrawal by subject, as mentioned in the participant flow, so the analysis of this outcome is calculated with those who finished the intervention | Posted | Mean | Standard Deviation | % of fat mass | Week 12 |
|
|
|
|
| Secondary | Total Cholesterol | Total cholesterol levels were evaluated at week 12 by enzymatic/colorimetric techniques and the entered values reflect the total cholesterol level at week 12 | Two of the study groups have one less patient due to withdrawal by subject, as mentioned in the participant flow, so the analysis of this outcome is calculated with those who finished the intervention | Posted | Mean | Standard Deviation | mmol/L | Week 12 |
|
|
|
|
| Secondary | Triglycerides | Triglycerides levels were evaluated at week 12 with enzymatic/colorimetric techniques and the entered values reflect the triglycerides level at week 12 | Two of the study groups have one less patient due to withdrawal by subject, as mentioned in the participant flow, so the analysis of this outcome is calculated with those who finished the intervention | Posted | Mean | Standard Deviation | mmol/L | Week 12 |
|
|
|
|
| Secondary | High Density Lipoprotein Cholesterol (c-HDL) | c-HDL levels were evaluated at week 12 with enzymatic/colorimetric techniques and the entered values reflect the c-HDL level at week 12 | Two of the study groups have one less patient due to withdrawal by subject, as mentioned in the participant flow, so the analysis of this outcome is calculated with those who finished the intervention | Posted | Mean | Standard Deviation | mmol/L | Week 12 |
|
|
|
|
| Secondary | Low Density Lipoproteins Cholesterol (c-LDL) | c-LDL levels were evaluated at week 12 with enzymatic/colorimetric techniques and the entered values reflect the c-LDL level at week 12 | Two of the study groups have one less patient due to withdrawal by subject, as mentioned in the participant flow, so the analysis of this outcome is calculated with those who finished the intervention | Posted | Mean | Standard Deviation | mmol/L | Week 12 |
|
|
|
|
| Secondary | Very Low Density Lipoprotein (c-VLDL) | Very low density lipoprotein (c-VLDL) was analyzed with the cholesterol oxidase/peroxidase technique by enzymatic colorimetric methods on an automatic analyzer. | Two of the study groups have one less patient due to withdrawal by subject, as mentioned in the participant flow, so the analysis of this outcome is calculated with those who finished the intervention | Posted | Mean | Standard Deviation | mmol/L | Week 12 |
|
|
|
|
| Secondary | Creatinine | Creatinine levels were evaluated at week 12 with enzymatic/colorimetric techniques | Two of the study groups have one less patient due to withdrawal by subject, as mentioned in the participant flow, so the analysis of this outcome is calculated with those who finished the intervention | Posted | Mean | Standard Deviation | mmol/L | Week 12 |
|
|
|
|
| Secondary | Uric Acid | Uric acid levels were evaluated at week 12 with enzymatic/colorimetric techniques | Two of the study groups have one less patient due to withdrawal by subject, as mentioned in the participant flow, so the analysis of this outcome is calculated with those who finished the intervention | Posted | Mean | Standard Deviation | mmol/L | Week 12 |
|
|
|
|
| Secondary | Systolic Blood Pressure | The systolic blood pressure was evaluated at week 12 with a digital sphygmomanometer and the entered values reflect the systolic blood pressure at week 12. | Two of the study groups have one less patient due to withdrawal by subject, as mentioned in the participant flow, so the analysis of this outcome is calculated with those who finished the intervention | Posted | Mean | Standard Deviation | mmHg | Week 12 |
|
|
|
|
| Secondary | Diastolic Blood Pressure | The diastolic blood pressure was evaluated at week 12 with a digital sphygmomanometer and the entered values reflect the diastolic blood pressure at week 12. | Two of the study groups have one less patient due to withdrawal by subject, as mentioned in the participant flow, so the analysis of this outcome is calculated with those who finished the intervention | Posted | Median | Standard Deviation | mmHg | Week 12 |
|
|
|
|
| 0 |
| 12 |
| 0 |
| 12 |
| 1 |
| 12 |
| EG001 | Metformin | Metformin capsules, 850 mg, two times per day before break-fast and dinner during 12 weeks. Metformin: Metformin capsules, 850 mg, two times per day before break-fast and dinner during 12 weeks. | 0 | 12 | 0 | 12 | 3 | 12 |
| EG002 | Placebo | Placebo capsules, two times per day before break-fast and dinner during 12 weeks. Placebo: Calcined magnesium, two times per day before break-fast and dinner during 12 weeks. | 0 | 12 | 0 | 12 | 5 | 12 |
| Loose stools | Gastrointestinal disorders | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | Systematic Assessment |
|
| Hyperphagia | Metabolism and nutrition disorders | Systematic Assessment |
|
| Headache | Nervous system disorders | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | Systematic Assessment |
|
Not provided
Not provided
| D004700 | Endocrine System Diseases |
| D053147 |
| Plant Exudates |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |