Diabetes Mellitus Type 2
Conditions
Keywords
Momordica Charantia, Insulin secretion, Insulin sensitivity
Brief summary
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.
Detailed description
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.
Interventions
Momordica Charantia: 2000 mg per day for three months
DRUGPlacebo
Placebo: 2000 mg per day for three months
Sponsors
University of Guadalajara
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
35 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* Diagnosis of diabetes mellitus type 2 according to the criteria of the American Diabetes Association (\<5 years), without pharmacological treatment (oral antidiabetic drugs or insulin) at least for three months before entering the study * Fasting glucose: \<210 mg/dl * A1C: 7-9% * Body mass index: 25-34.9 kg/m2 * Body weight without variations above or under 5% in the last three months before entering the study * Women in childbearing years must have a contraceptive method * Letter of consent and release signed by each patient
Exclusion criteria
* Pregnant or suspected pregnant women * Woman breastfeeding * Medications known to affect metabolism of glucose and insulin * Personal history of liver or renal disease * Hypertension, thyroid or cardiovascular disease decompensated * Total cholesterol \>= 240mg/dl, triglycerides \>=400mg/dl, glomerular filtration rate \<=60ml/min or liver transaminases \>=2.5 the upper normal limit
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total and First Phase of Insulin Secretion (Insulinogenic Index and Stumvoll Index) After 90 Days | 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 |
| Insulin Sensitivity (Matsuda Index) After 90 Days | 90 days | Insulin sensitivity was calculated at baseline and after 90 days with Matsuda index \[10,000 / √glucose 0' x insulin 0') (mean glucose oral glucose tolerance test (OGTT) x mean insulin OGTT)\] |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Total Cholesterol After 90 Days | 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 |
| Triglycerides After 90 Days | 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 |
| High Density Lipoprotein Cholesterol (HDL-c) After 90 Days | 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 |
| Low Density Lipoprotein Cholesterol (LDL-c) After 90 Days | 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 |
| Very Low Density Lipoprotein After 90 Days | 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 |
| Alanine Aminotransferase (ALT) After 90 Days | 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 |
| Aspartate Aminotransferase (AST) After 90 Days | 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 |
| Creatinine After 90 Days | 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 |
| Fasting Serum Glucose (FSG) After 90 Days | 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 |
| Diastolic Blood Pressure After 90 Days | 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 |
| Body Weight (BW) After 90 Days | 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. |
| Body Mass Index (BMI) After 90 Days | 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 |
| Fat Mass After 90 Days | 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) |
| Waist Circumference (WC) After 90 Days | 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 |
| 2-h Serum Glucose After 90 Days | 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% |
| AUC-glucose After 90 Days | 90 days | The polygonal formula was used to calculate area under the curve (AUC) of glucose at baseline and after 90 days |
| AUC-insulin After 90 Days | 90 days | The polygonal formula was used to calculate area under the curve (AUC) of insulin at baseline and after 90 days |
| Systolic Blood Pressure After 90 Days | 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 |
| A1C After 90 Days | 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 |
Countries
Mexico
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 12 |
| 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 | 12 |
| Total | 24 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 2 | 2 |
Baseline characteristics
| Characteristic | Total | Placebo | Momordica Charantia |
|---|---|---|---|
| 2-h serum glucose | 16.0 mmol/L STANDARD_DEVIATION 4.3 | 14.9 mmol/L STANDARD_DEVIATION 4.7 | 17.1 mmol/L STANDARD_DEVIATION 3.7 |
| A1C | 7.7 percentage STANDARD_DEVIATION 0.7 | 7.6 percentage STANDARD_DEVIATION 0.6 | 7.8 percentage STANDARD_DEVIATION 0.8 |
| Age, Continuous | 48.6 years STANDARD_DEVIATION 7.4 | 47 years STANDARD_DEVIATION 7.4 | 50.1 years STANDARD_DEVIATION 7.3 |
| Alanine aminotransferase (ALT) | 35.71 U/L STANDARD_DEVIATION 21.7 | 36.0 U/L STANDARD_DEVIATION 19.7 | 35.4 U/L STANDARD_DEVIATION 24.4 |
| Aspartate aminotransferase (AST) | 26.08 U/L STANDARD_DEVIATION 17.68 | 23.1 U/L STANDARD_DEVIATION 11.3 | 29.0 U/L STANDARD_DEVIATION 22.4 |
| AUC-glucose | 1754.1 mmol/L/min STANDARD_DEVIATION 344 | 1670 mmol/L/min STANDARD_DEVIATION 380 | 1840 mmol/L/min STANDARD_DEVIATION 295 |
| AUC-insulin | 48951 pmol/L/min STANDARD_DEVIATION 30369 | 41334 pmol/L/min STANDARD_DEVIATION 22356 | 56562 pmol/L/min STANDARD_DEVIATION 36078 |
| Body mass index (BMI) | 28.9 kg/m^2 STANDARD_DEVIATION 3.2 | 28.8 kg/m^2 STANDARD_DEVIATION 3.9 | 29.1 kg/m^2 STANDARD_DEVIATION 2.4 |
| Body weight (BW) | 76.5 kg STANDARD_DEVIATION 10.4 | 73.6 kg STANDARD_DEVIATION 11.1 | 79.4 kg STANDARD_DEVIATION 9.2 |
| Creatinine | 70.36 mmol/L STANDARD_DEVIATION 8.84 | 61.88 mmol/L STANDARD_DEVIATION 8.84 | 70.72 mmol/L STANDARD_DEVIATION 8.84 |
| Diastolic blood pressure (DBP) | 74.6 mmHg STANDARD_DEVIATION 5 | 74.2 mmHg STANDARD_DEVIATION 5.5 | 75 mmHg STANDARD_DEVIATION 4.7 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 24 Participants | 12 Participants | 12 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 serum glucose (FSG) | 7.6 mmol/L STANDARD_DEVIATION 1.7 | 7.1 mmol/L STANDARD_DEVIATION 1.9 | 8.2 mmol/L STANDARD_DEVIATION 1.4 |
| Fat mass | 36.0 body fat percentage STANDARD_DEVIATION 7.8 | 35.2 body fat percentage STANDARD_DEVIATION 8.1 | 36.7 body fat percentage STANDARD_DEVIATION 7.8 |
| High-density lipoprotein cholesterol (HDL-c) | 1.09 mmol/L STANDARD_DEVIATION 0.21 | 1.04 mmol/L STANDARD_DEVIATION 0.23 | 1.13 mmol/L STANDARD_DEVIATION 0.18 |
| Insulinogenic index (total insulin secretion) | 0.26 index STANDARD_DEVIATION 0.16 | 0.23 index STANDARD_DEVIATION 0.14 | 0.29 index STANDARD_DEVIATION 0.18 |
| Low-density lipoprotein cholesterol (LDL-c) | 2.52 mmol/L STANDARD_DEVIATION 0.73 | 2.35 mmol/L STANDARD_DEVIATION 0.64 | 2.69 mmol/L STANDARD_DEVIATION 0.8 |
| Matsuda index (insulin sensitivity) | 3.1 index STANDARD_DEVIATION 3.4 | 3.8 index STANDARD_DEVIATION 4.6 | 2.4 index STANDARD_DEVIATION 1.4 |
| Region of Enrollment Mexico | 24 participants | 12 participants | 12 participants |
| Sex: Female, Male Female | 16 Participants | 9 Participants | 7 Participants |
| Sex: Female, Male Male | 8 Participants | 3 Participants | 5 Participants |
| Stumvoll index (first phase of insulin secretion) | 488.6 index STANDARD_DEVIATION 698 | 419.3 index STANDARD_DEVIATION 769.1 | 557.8 index STANDARD_DEVIATION 645.6 |
| Systolic blood pressure (SBP) | 118.0 mmHg STANDARD_DEVIATION 9.8 | 116.5 mmHg STANDARD_DEVIATION 10.8 | 119.5 mmHg STANDARD_DEVIATION 8.9 |
| Total cholesterol | 4.65 mmol/L STANDARD_DEVIATION 0.76 | 4.41 mmol/L STANDARD_DEVIATION 0.75 | 4.89 mmol/L STANDARD_DEVIATION 0.73 |
| Triglycerides | 2.25 mmol/L STANDARD_DEVIATION 1 | 2.19 mmol/L STANDARD_DEVIATION 0.76 | 2.31 mmol/L STANDARD_DEVIATION 1.25 |
| Very low-density lipoprotein (VLDL) | 8.07 mmol/L STANDARD_DEVIATION 3.63 | 7.86 mmol/L STANDARD_DEVIATION 2.7 | 8.26 mmol/L STANDARD_DEVIATION 4.48 |
| Waist circumference (WC) | 101.9 cm STANDARD_DEVIATION 12.1 | 97 cm STANDARD_DEVIATION 11 | 106 cm STANDARD_DEVIATION 12 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 4 / 12 | 3 / 12 |
| serious Total, serious adverse events | 0 / 12 | 0 / 12 |
Outcome results
Primary
Insulin Sensitivity (Matsuda Index) After 90 Days
Insulin sensitivity was calculated at baseline and after 90 days with Matsuda index \[10,000 / √glucose 0' x insulin 0') (mean glucose oral glucose tolerance test (OGTT) x mean insulin OGTT)\]
Time frame: 90 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Momordica Charantia | Insulin Sensitivity (Matsuda Index) After 90 Days | 2.1 index | Standard Deviation 1.6 |
| Placebo | Insulin Sensitivity (Matsuda Index) After 90 Days | 2.3 index | Standard Deviation 1 |
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
Time frame: 90 days
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Momordica Charantia | Total and First Phase of Insulin Secretion (Insulinogenic Index and Stumvoll Index) After 90 Days | Total insulin secretion (Insulinogenic index) | 0.41 index | Standard Deviation 0.29 |
| Momordica Charantia | Total and First Phase of Insulin Secretion (Insulinogenic Index and Stumvoll Index) After 90 Days | First Phase of Insulin Secretion (Stumvoll index) | 1135.7 index | Standard Deviation 725 |
| Placebo | Total and First Phase of Insulin Secretion (Insulinogenic Index and Stumvoll Index) After 90 Days | Total insulin secretion (Insulinogenic index) | 0.23 index | Standard Deviation 0.12 |
| Placebo | Total and First Phase of Insulin Secretion (Insulinogenic Index and Stumvoll Index) After 90 Days | First Phase of Insulin Secretion (Stumvoll index) | 309.0 index | Standard Deviation 776.5 |
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%
Time frame: 90 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Momordica Charantia | 2-h Serum Glucose After 90 Days | 13.2 mmol/L | Standard Deviation 4.3 |
| Placebo | 2-h Serum Glucose After 90 Days | 14.3 mmol/L | Standard Deviation 4.3 |
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
Time frame: 90 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Momordica Charantia | A1C After 90 Days | 7.1 percentage | Standard Deviation 1.3 |
| Placebo | A1C After 90 Days | 7.1 percentage | Standard Deviation 1.1 |
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
Time frame: 90 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Momordica Charantia | Alanine Aminotransferase (ALT) After 90 Days | 28.1 U/L | Standard Deviation 19.4 |
| Placebo | Alanine Aminotransferase (ALT) After 90 Days | 38.2 U/L | Standard Deviation 18.9 |
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
Time frame: 90 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Momordica Charantia | Aspartate Aminotransferase (AST) After 90 Days | 23.9 U/L | Standard Deviation 16.5 |
| Placebo | Aspartate Aminotransferase (AST) After 90 Days | 24.4 U/L | Standard Deviation 6.7 |
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
Time frame: 90 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Momordica Charantia | AUC-glucose After 90 Days | 1576 mmol/L/min | Standard Deviation 391 |
| Placebo | AUC-glucose After 90 Days | 1663 mmol/L/min | Standard Deviation 363 |
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
Time frame: 90 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Momordica Charantia | AUC-insulin After 90 Days | 65256 pmol/L/min | Standard Deviation 42720 |
| Placebo | AUC-insulin After 90 Days | 41310 pmol/L/min | Standard Deviation 20292 |
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
Time frame: 90 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Momordica Charantia | Body Mass Index (BMI) After 90 Days | 28.3 kg/m^2 | Standard Deviation 1.9 |
| Placebo | Body Mass Index (BMI) After 90 Days | 28.9 kg/m^2 | Standard Deviation 3.6 |
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.
Time frame: 90 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Momordica Charantia | Body Weight (BW) After 90 Days | 78.0 kg | Standard Deviation 9.2 |
| Placebo | Body Weight (BW) After 90 Days | 73.4 kg | Standard Deviation 10.8 |
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
Time frame: 90 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Momordica Charantia | Creatinine After 90 Days | 70.72 mmol/L | Standard Deviation 35.36 |
| Placebo | Creatinine After 90 Days | 79.56 mmol/L | Standard Deviation 0 |
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
Time frame: 90 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Momordica Charantia | Diastolic Blood Pressure After 90 Days | 75.1 mmHg | Standard Deviation 6.5 |
| Placebo | Diastolic Blood Pressure After 90 Days | 72.6 mmHg | Standard Deviation 4.7 |
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
Time frame: 90 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Momordica Charantia | Fasting Serum Glucose (FSG) After 90 Days | 7.4 mmol/L | Standard Deviation 2.9 |
| Placebo | Fasting Serum Glucose (FSG) After 90 Days | 7.2 mmol/L | Standard Deviation 2.3 |
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)
Time frame: 90 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Momordica Charantia | Fat Mass After 90 Days | 36.3 percentage | Standard Deviation 7.6 |
| Placebo | Fat Mass After 90 Days | 35.8 percentage | Standard Deviation 6.9 |
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
Time frame: 90 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Momordica Charantia | High Density Lipoprotein Cholesterol (HDL-c) After 90 Days | 1.05 mmol/L | Standard Deviation 0.31 |
| Placebo | High Density Lipoprotein Cholesterol (HDL-c) After 90 Days | 1.09 mmol/L | Standard Deviation 0.27 |
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
Time frame: 90 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Momordica Charantia | Low Density Lipoprotein Cholesterol (LDL-c) After 90 Days | 2.75 mmol/L | Standard Deviation 0.96 |
| Placebo | Low Density Lipoprotein Cholesterol (LDL-c) After 90 Days | 2.41 mmol/L | Standard Deviation 0.48 |
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
Time frame: 90 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Momordica Charantia | Systolic Blood Pressure After 90 Days | 119.6 mmHg | Standard Deviation 9.5 |
| Placebo | Systolic Blood Pressure After 90 Days | 115.4 mmHg | Standard Deviation 9.8 |
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
Time frame: 90 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Momordica Charantia | Total Cholesterol After 90 Days | 4.68 mmol/L | Standard Deviation 1.02 |
| Placebo | Total Cholesterol After 90 Days | 4.39 mmol/L | Standard Deviation 0.52 |
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
Time frame: 90 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Momordica Charantia | Triglycerides After 90 Days | 1.93 mmol/L | Standard Deviation 0.92 |
| Placebo | Triglycerides After 90 Days | 2.02 mmol/L | Standard Deviation 0.56 |
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
Time frame: 90 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Momordica Charantia | Very Low Density Lipoprotein After 90 Days | 6.92 mmol/L | Standard Deviation 3.32 |
| Placebo | Very Low Density Lipoprotein After 90 Days | 7.22 mmol/L | Standard Deviation 1.98 |
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
Time frame: 90 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Momordica Charantia | Waist Circumference (WC) After 90 Days | 104 cm | Standard Deviation 11 |
| Placebo | Waist Circumference (WC) After 90 Days | 98 cm | Standard Deviation 10 |