Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The hypoglycemic effect of Momordica Charantia has been evaluated in clinical trials in patients with type 2 diabetes mellitus. Important reductions in fasting plasma glucose, glycated hemoglobin (A1C), and fructosamine were observed. It is unknown whether this improvement is due to an improvement in insulin sensitivity and insulin secretion. The purpose of this study is to evaluate the effect of the administration of Momordica Charantia on insulin sensitivity and insulin secretion in patients with type 2 diabetes mellitus.
A randomized, double-blind, placebo controlled clinical trial is carried out in 24 patients with diagnosis of diabetes mellitus type 2 according to the criteria of the American Diabetes Association. Patients are assigned to two different arms: one group receives Momordica Charantia, 2 capsules with 500 mg twice daily before breakfast and dinner for 90 days or placebo, under the same scheme of treatment.
An oral glucose tolerance test is performed before and after the intervention. Matsuda index, Stumvoll index and Insulinogenic index are calculated to assess insulin sensitivity and insulin secretion.
Other clinical and laboratory parameters that are evaluated include: Body weight, body mass index, waist circumference, blood pressure, body fat percentage, fasting plasma glucose, A1C, creatinine, lipid profile and liver transaminases.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Momordica charantia | Experimental | Two 500 mg capsules of Momordica Charantia twice daily before breakfast and dinner for 90 days |
|
| Placebo | Placebo Comparator | Two 500 mg capsules of calcined magnesia twice daily before breakfast and dinner for 90 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Momordica charantia | Drug | Momordica Charantia: 2000 mg per day for three months |
|
| Measure | Description | Time Frame |
|---|---|---|
| Total and First Phase of Insulin Secretion (Insulinogenic Index and Stumvoll Index) After 90 Days | Total insulin secretion and first phase of insulin secretion were estimated at baseline and after 90 days using the insulinogenic index (ΔABC insulin / ΔABC glucose) and the Stumvoll index (1283+ 1.829 x insulin 30' - 138.7 x glucose 30' + 3.772 x insulin 0'), respectively | 90 days |
| Insulin Sensitivity (Matsuda Index) After 90 Days | Insulin sensitivity was calculated at baseline and after 90 days with Matsuda index [10,000 / √glucose 0' x insulin 0') (mean glucose oral glucose tolerance test (OGTT) x mean insulin OGTT)] | 90 days |
| Measure | Description | Time Frame |
|---|---|---|
| Fasting Serum Glucose (FSG) After 90 Days | The glucose oxidase technique (Beckman Instruments, Inc., Brea, CA, USA) was used to determine fasting serum glucose at baseline and after 90 days with an intra- and interassay coefficient of variation of<1 | 90 days |
| A1C After 90 Days |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Esperanza Martínez Abundis, PhD Science | Institute of Experimental and Clinical Therapeutics (INTEC), CUCS, University of Guadalajara | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute of Experimental and Clinical Therapeutics (INTEC), CUCS, University of Guadalajara | Guadalajara | Jalisco | 44340 | Mexico |
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Momordica Charantia | Two 500 mg capsules of Momordica Charantia twice daily before breakfast and dinner for 90 days Momordica charantia: Momordica Charantia: 2000 mg per day for three months |
| FG001 | Placebo | Two 500 mg capsules of calcined magnesia twice daily before breakfast and dinner for 90 days Placebo: Placebo: 2000 mg per day for three months |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Momordica Charantia | Two 500 mg capsules of Momordica Charantia twice daily before breakfast and dinner for 90 days Momordica charantia: Momordica Charantia: 2000 mg per day for three months |
| 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 | Total and First Phase of Insulin Secretion (Insulinogenic Index and Stumvoll Index) After 90 Days | Total insulin secretion and first phase of insulin secretion were estimated at baseline and after 90 days using the insulinogenic index (ΔABC insulin / ΔABC glucose) and the Stumvoll index (1283+ 1.829 x insulin 30' - 138.7 x glucose 30' + 3.772 x insulin 0'), respectively | Posted | Mean | Standard Deviation | index | 90 days |
|
Adverse events were collected throughout the 90 days of the study
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Momordica Charantia | Two 500 mg capsules of Momordica Charantia twice daily before breakfast and dinner for 90 days Momordica charantia: Momordica Charantia: 2000 mg per day for three months |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | Non-systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dra. Esperanza Martínez Abundis | Institute of Experimental and Clinical Therapeutics | +52-33-10-58-52-00 | 34211 | esperanzamartnezabundi@yahoo.com |
Not provided
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D007333 | Insulin Resistance |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo | Drug | Placebo: 2000 mg per day for three months |
|
|
A liquid chromatography method was used to evaluate A1C at baseline and after 90 days (Bio-Rad Laboratories, Hercules, CA, USA) with an intra and inter assay coefficient of variation of 0.4% and 1.6%, respectively |
| 90 days |
| Total Cholesterol After 90 Days | The blood sample for the determination of total cholesterol was taken after an overnight fast and was evaluated at baseline and after 90 days by spectrophotometry method | 90 days |
| Triglycerides After 90 Days | The blood sample for the determination of triglycerides was taken after an overnight fast and was evaluated at baseline and after 90 days by spectrophotometry method | 90 days |
| High Density Lipoprotein Cholesterol (HDL-c) After 90 Days | The blood sample for the determination of high density lipoprotein cholesterol was taken after an overnight fast and was evaluated at baseline and after 90 days by spectrophotometry method | 90 days |
| Low Density Lipoprotein Cholesterol (LDL-c) After 90 Days | The blood sample for the determination of low density lipoprotein cholesterol was taken after an overnight fast and was evaluated at baseline and after 90 days by spectrophotometry method | 90 days |
| Very Low Density Lipoprotein After 90 Days | The blood sample for the determination of VLDL was taken after an overnight fast and was calculated at baseline and after 90 days as triglycerides/5 | 90 days |
| Alanine Aminotransferase (ALT) After 90 Days | The blood sample for the determination of ALT was taken after an overnight fast and was evaluated at baseline and after 90 days by spectrophotometry method | 90 days |
| Aspartate Aminotransferase (AST) After 90 Days | The blood sample for the determination of AST was taken after an overnight fast and was evaluated at baseline and after 90 days by spectrophotometry method | 90 days |
| Creatinine After 90 Days | The blood sample for the determination of creatinine was taken after an overnight fast and was evaluated at baseline and after 90 days by spectrophotometry method | 90 days |
| Systolic Blood Pressure After 90 Days | The systolic blood pressure was evaluated at baseline and after 90 days 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 SBP. The value was expressed on mmHg | 90 days |
| Diastolic Blood Pressure After 90 Days | The diastolic blood pressure was evaluated at baseline and after 90 days 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 DBP. The value was expressed on mmHg | 90 days |
| Body Weight (BW) After 90 Days | The body weight was evaluated at baseline and after 90 days after an overnight fast, through a bioimpedance digital scale results are reported in kilograms with a decimal. | 90 days |
| Body Mass Index (BMI) After 90 Days | The BMI was calculated at baseline and after 90 days by the square of the body height, and is universally expressed in units of kg/m^2, resulting from mass in kilograms and height in metres | 90 days |
| Fat Mass After 90 Days | Fat mass was measured at baseline and after 90 days with an electric bioimpedance scale (Model TBF-300 A; Tanita Corporation of America Inc., Arlington Heights, IL) | 90 days |
| Waist Circumference (WC) After 90 Days | The waist circumference was evaluated at baseline and after 90 days after an overnight fast with a flexible tape in the midpoint between the lowest rib and the iliac crest and is expressed in centimeters | 90 days |
| 2-h Serum Glucose After 90 Days | The glucose oxidase technique (Beckman Instruments, Inc., Brea, CA, USA) was used to determine serum glucose at baseline and after 90 days with an intra- and interassay coefficient of variation of<1% | 90 days |
| AUC-glucose After 90 Days | The polygonal formula was used to calculate area under the curve (AUC) of glucose at baseline and after 90 days | 90 days |
| AUC-insulin After 90 Days | The polygonal formula was used to calculate area under the curve (AUC) of insulin at baseline and after 90 days | 90 days |
Two 500 mg capsules of calcined magnesia twice daily before breakfast and dinner for 90 days
Placebo: Placebo: 2000 mg per day for three months
| 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 |
|
| Body weight (BW) | The BW was evaluated after an overnight fast, through a bioimpedance digital scale results are reported in kilograms with a decimal. | Mean | Standard Deviation | kg |
|
| Body mass index (BMI) | The BMI was calculated by the square of the body height, and is universally expressed in units of kg/m2, resulting from mass in kilograms and height in metres. | Mean | Standard Deviation | kg/m^2 |
|
| Fat mass | Fat mass was measured with an electric bioimpedance scale (Model TBF-300 A; Tanita Corporation of America Inc., Arlington Heights, IL) | Mean | Standard Deviation | body fat percentage |
|
| Waist circumference (WC) | The WC was evaluated after an overnight fast with a flexible tape in the midpoint between the lowest rib and the iliac crest and is expressed in centimeters | Mean | Standard Deviation | cm |
|
| Systolic blood pressure (SBP) | The SBP 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 SBP. The value was expressed on mmHg. | Mean | Standard Deviation | mmHg |
|
| Diastolic blood pressure (DBP) | The DBP 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 DBP. The value was expressed on mmHg | Mean | Standard Deviation | mmHg |
|
| A1C | A liquid chromatography method was used (Bio-Rad Laboratories, Hercules, CA, USA) with an intra and inter assay coefficient of variation of 0.4% and 1.6%, respectively | Mean | Standard Deviation | percentage |
|
| Fasting serum glucose (FSG) | The glucose oxidase technique (Beckman Instruments, Inc., Brea, CA, USA) was used to determine serum glucose with an intra- and interassay coefficient of variation of<1% | Mean | Standard Deviation | mmol/L |
|
| 2-h serum glucose | The glucose oxidase technique (Beckman Instruments, Inc., Brea, CA, USA) was used to determine serum glucose with an intra- and interassay coefficient of variation of<1% | Mean | Standard Deviation | mmol/L |
|
| AUC-glucose | The polygonal formula was used to calculate area under the curve (AUC) of glucose and insulin | Mean | Standard Deviation | mmol/L/min |
|
| AUC-insulin | The polygonal formula was used to calculate area under the curve (AUC) of glucose and insulin | Mean | Standard Deviation | pmol/L/min |
|
| Insulinogenic index (total insulin secretion) | Total insulin secretion was calculated with the insulinogenic index (ΔABC insulin / ΔABC glucose) | Mean | Standard Deviation | index |
|
| Stumvoll index (first phase of insulin secretion) | 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') | Mean | Standard Deviation | index |
|
| Matsuda index (insulin sensitivity) | 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)] | Mean | Standard Deviation | index |
|
| Total cholesterol | The blood sample for the determination of total cholesterol was taken after an overnight fast and was evaluated by spectrophotometry method | Mean | Standard Deviation | mmol/L |
|
| Triglycerides | The blood sample for the determination of triglycerides was taken after an overnight fast and was evaluated by spectrophotometry method | Mean | Standard Deviation | mmol/L |
|
| High-density lipoprotein cholesterol (HDL-c) | The blood sample for the determination of HDL-c was taken after an overnight fast and was evaluated by spectrophotometry method | Mean | Standard Deviation | mmol/L |
|
| Low-density lipoprotein cholesterol (LDL-c) | The blood sample for the determination of LDL-C was taken after an overnight fast and was calculated by Friedewald formula | Median | Standard Deviation | mmol/L |
|
| Very low-density lipoprotein (VLDL) | The blood sample for the determination of VLDL was taken after an overnight fast and was calculated as triglycerides/5 | Mean | Standard Deviation | mmol/L |
|
| Creatinine | The blood sample for the determination of creatinine was taken after an overnight fast and was evaluated by spectrophotometry method | Mean | Standard Deviation | mmol/L |
|
| Alanine aminotransferase (ALT) | The blood sample for the determination of ALT was taken after an overnight fast and was evaluated by spectrophotometry method | Mean | Standard Deviation | U/L |
|
| Aspartate aminotransferase (AST) | The blood sample for the determination of AST was taken after an overnight fast and was evaluated by spectrophotometry method | Mean | Standard Deviation | U/L |
|
|
|
| Primary | Insulin Sensitivity (Matsuda Index) After 90 Days | Insulin sensitivity was calculated at baseline and after 90 days with Matsuda index [10,000 / √glucose 0' x insulin 0') (mean glucose oral glucose tolerance test (OGTT) x mean insulin OGTT)] | Posted | Mean | Standard Deviation | index | 90 days |
|
|
|
| Secondary | Fasting Serum Glucose (FSG) After 90 Days | The glucose oxidase technique (Beckman Instruments, Inc., Brea, CA, USA) was used to determine fasting serum glucose at baseline and after 90 days with an intra- and interassay coefficient of variation of<1 | Posted | Mean | Standard Deviation | mmol/L | 90 days |
|
|
|
| Secondary | A1C After 90 Days | A liquid chromatography method was used to evaluate A1C at baseline and after 90 days (Bio-Rad Laboratories, Hercules, CA, USA) with an intra and inter assay coefficient of variation of 0.4% and 1.6%, respectively | Posted | Mean | Standard Deviation | percentage | 90 days |
|
|
|
| Secondary | Total Cholesterol After 90 Days | The blood sample for the determination of total cholesterol was taken after an overnight fast and was evaluated at baseline and after 90 days by spectrophotometry method | Posted | Mean | Standard Deviation | mmol/L | 90 days |
|
|
|
| Secondary | Triglycerides After 90 Days | The blood sample for the determination of triglycerides was taken after an overnight fast and was evaluated at baseline and after 90 days by spectrophotometry method | Posted | Mean | Standard Deviation | mmol/L | 90 days |
|
|
|
| Secondary | High Density Lipoprotein Cholesterol (HDL-c) After 90 Days | The blood sample for the determination of high density lipoprotein cholesterol was taken after an overnight fast and was evaluated at baseline and after 90 days by spectrophotometry method | Posted | Mean | Standard Deviation | mmol/L | 90 days |
|
|
|
| Secondary | Low Density Lipoprotein Cholesterol (LDL-c) After 90 Days | The blood sample for the determination of low density lipoprotein cholesterol was taken after an overnight fast and was evaluated at baseline and after 90 days by spectrophotometry method | Posted | Mean | Standard Deviation | mmol/L | 90 days |
|
|
|
| Secondary | Very Low Density Lipoprotein After 90 Days | The blood sample for the determination of VLDL was taken after an overnight fast and was calculated at baseline and after 90 days as triglycerides/5 | Posted | Mean | Standard Deviation | mmol/L | 90 days |
|
|
|
| Secondary | Alanine Aminotransferase (ALT) After 90 Days | The blood sample for the determination of ALT was taken after an overnight fast and was evaluated at baseline and after 90 days by spectrophotometry method | Posted | Mean | Standard Deviation | U/L | 90 days |
|
|
|
| Secondary | Aspartate Aminotransferase (AST) After 90 Days | The blood sample for the determination of AST was taken after an overnight fast and was evaluated at baseline and after 90 days by spectrophotometry method | Posted | Mean | Standard Deviation | U/L | 90 days |
|
|
|
| Secondary | Creatinine After 90 Days | The blood sample for the determination of creatinine was taken after an overnight fast and was evaluated at baseline and after 90 days by spectrophotometry method | Posted | Mean | Standard Deviation | mmol/L | 90 days |
|
|
|
| Secondary | Systolic Blood Pressure After 90 Days | The systolic blood pressure was evaluated at baseline and after 90 days 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 SBP. The value was expressed on mmHg | Posted | Mean | Standard Deviation | mmHg | 90 days |
|
|
|
| Secondary | Diastolic Blood Pressure After 90 Days | The diastolic blood pressure was evaluated at baseline and after 90 days 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 DBP. The value was expressed on mmHg | Posted | Mean | Standard Deviation | mmHg | 90 days |
|
|
|
| Secondary | Body Weight (BW) After 90 Days | The body weight was evaluated at baseline and after 90 days after an overnight fast, through a bioimpedance digital scale results are reported in kilograms with a decimal. | Posted | Mean | Standard Deviation | kg | 90 days |
|
|
|
| Secondary | Body Mass Index (BMI) After 90 Days | The BMI was calculated at baseline and after 90 days by the square of the body height, and is universally expressed in units of kg/m^2, resulting from mass in kilograms and height in metres | Posted | Mean | Standard Deviation | kg/m^2 | 90 days |
|
|
|
| Secondary | Fat Mass After 90 Days | Fat mass was measured at baseline and after 90 days with an electric bioimpedance scale (Model TBF-300 A; Tanita Corporation of America Inc., Arlington Heights, IL) | Posted | Mean | Standard Deviation | percentage | 90 days |
|
|
|
| Secondary | Waist Circumference (WC) After 90 Days | The waist circumference was evaluated at baseline and after 90 days after an overnight fast with a flexible tape in the midpoint between the lowest rib and the iliac crest and is expressed in centimeters | Posted | Mean | Standard Deviation | cm | 90 days |
|
|
|
| Secondary | 2-h Serum Glucose After 90 Days | The glucose oxidase technique (Beckman Instruments, Inc., Brea, CA, USA) was used to determine serum glucose at baseline and after 90 days with an intra- and interassay coefficient of variation of<1% | Posted | Mean | Standard Deviation | mmol/L | 90 days |
|
|
|
| Secondary | AUC-glucose After 90 Days | The polygonal formula was used to calculate area under the curve (AUC) of glucose at baseline and after 90 days | Posted | Mean | Standard Deviation | mmol/L/min | 90 days |
|
|
|
| Secondary | AUC-insulin After 90 Days | The polygonal formula was used to calculate area under the curve (AUC) of insulin at baseline and after 90 days | Posted | Mean | Standard Deviation | pmol/L/min | 90 days |
|
|
|
| 0 |
| 12 |
| 4 |
| 12 |
| EG001 | Placebo | Two 500 mg capsules of calcined magnesia twice daily before breakfast and dinner for 90 days Placebo: Placebo: 2000 mg per day for three months | 0 | 12 | 3 | 12 |
| Constipation | Gastrointestinal disorders | Non-systematic Assessment |
|
| Abdominal distension | Gastrointestinal disorders | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | Non-systematic Assessment |
|
Not provided
Not provided
| D004700 | Endocrine System Diseases |
| D006946 | Hyperinsulinism |