Trial Outcomes & Findings for Effect of Momordica Charantia Administration on Type 2 Diabetes Mellitus, Insulin Sensitivity and Insulin Secretion (NCT NCT02397447)
NCT ID: NCT02397447
Last Updated: 2020-10-22
Results Overview
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
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
24 participants
Primary outcome timeframe
90 days
Results posted on
2020-10-22
Participant Flow
Participant milestones
| Measure |
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
|
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
|
|---|---|---|
|
Overall Study
STARTED
|
12
|
12
|
|
Overall Study
COMPLETED
|
10
|
10
|
|
Overall Study
NOT COMPLETED
|
2
|
2
|
Reasons for withdrawal
| Measure |
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
|
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
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
2
|
2
|
Baseline Characteristics
Effect of Momordica Charantia Administration on Type 2 Diabetes Mellitus, Insulin Sensitivity and Insulin Secretion
Baseline characteristics by cohort
| Measure |
Momordica Charantia
n=12 Participants
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
|
Placebo
n=12 Participants
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
|
Total
n=24 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
50.1 years
STANDARD_DEVIATION 7.3 • n=5 Participants
|
47 years
STANDARD_DEVIATION 7.4 • n=7 Participants
|
48.6 years
STANDARD_DEVIATION 7.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
12 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
Mexico
|
12 participants
n=5 Participants
|
12 participants
n=7 Participants
|
24 participants
n=5 Participants
|
|
Body weight (BW)
|
79.4 kg
STANDARD_DEVIATION 9.2 • n=5 Participants
|
73.6 kg
STANDARD_DEVIATION 11.1 • n=7 Participants
|
76.5 kg
STANDARD_DEVIATION 10.4 • n=5 Participants
|
|
Body mass index (BMI)
|
29.1 kg/m^2
STANDARD_DEVIATION 2.4 • n=5 Participants
|
28.8 kg/m^2
STANDARD_DEVIATION 3.9 • n=7 Participants
|
28.9 kg/m^2
STANDARD_DEVIATION 3.2 • n=5 Participants
|
|
Fat mass
|
36.7 body fat percentage
STANDARD_DEVIATION 7.8 • n=5 Participants
|
35.2 body fat percentage
STANDARD_DEVIATION 8.1 • n=7 Participants
|
36.0 body fat percentage
STANDARD_DEVIATION 7.8 • n=5 Participants
|
|
Waist circumference (WC)
|
106 cm
STANDARD_DEVIATION 12 • n=5 Participants
|
97 cm
STANDARD_DEVIATION 11 • n=7 Participants
|
101.9 cm
STANDARD_DEVIATION 12.1 • n=5 Participants
|
|
Systolic blood pressure (SBP)
|
119.5 mmHg
STANDARD_DEVIATION 8.9 • n=5 Participants
|
116.5 mmHg
STANDARD_DEVIATION 10.8 • n=7 Participants
|
118.0 mmHg
STANDARD_DEVIATION 9.8 • n=5 Participants
|
|
Diastolic blood pressure (DBP)
|
75 mmHg
STANDARD_DEVIATION 4.7 • n=5 Participants
|
74.2 mmHg
STANDARD_DEVIATION 5.5 • n=7 Participants
|
74.6 mmHg
STANDARD_DEVIATION 5.0 • n=5 Participants
|
|
A1C
|
7.8 percentage
STANDARD_DEVIATION 0.8 • n=5 Participants
|
7.6 percentage
STANDARD_DEVIATION 0.6 • n=7 Participants
|
7.7 percentage
STANDARD_DEVIATION 0.7 • n=5 Participants
|
|
Fasting serum glucose (FSG)
|
8.2 mmol/L
STANDARD_DEVIATION 1.4 • n=5 Participants
|
7.1 mmol/L
STANDARD_DEVIATION 1.9 • n=7 Participants
|
7.6 mmol/L
STANDARD_DEVIATION 1.7 • n=5 Participants
|
|
2-h serum glucose
|
17.1 mmol/L
STANDARD_DEVIATION 3.7 • n=5 Participants
|
14.9 mmol/L
STANDARD_DEVIATION 4.7 • n=7 Participants
|
16.0 mmol/L
STANDARD_DEVIATION 4.3 • n=5 Participants
|
|
AUC-glucose
|
1840 mmol/L/min
STANDARD_DEVIATION 295 • n=5 Participants
|
1670 mmol/L/min
STANDARD_DEVIATION 380 • n=7 Participants
|
1754.1 mmol/L/min
STANDARD_DEVIATION 344.0 • n=5 Participants
|
|
AUC-insulin
|
56562 pmol/L/min
STANDARD_DEVIATION 36078 • n=5 Participants
|
41334 pmol/L/min
STANDARD_DEVIATION 22356 • n=7 Participants
|
48951 pmol/L/min
STANDARD_DEVIATION 30369 • n=5 Participants
|
|
Insulinogenic index (total insulin secretion)
|
0.29 index
STANDARD_DEVIATION 0.18 • n=5 Participants
|
0.23 index
STANDARD_DEVIATION 0.14 • n=7 Participants
|
0.26 index
STANDARD_DEVIATION 0.16 • n=5 Participants
|
|
Stumvoll index (first phase of insulin secretion)
|
557.8 index
STANDARD_DEVIATION 645.6 • n=5 Participants
|
419.3 index
STANDARD_DEVIATION 769.1 • n=7 Participants
|
488.6 index
STANDARD_DEVIATION 698.0 • n=5 Participants
|
|
Matsuda index (insulin sensitivity)
|
2.4 index
STANDARD_DEVIATION 1.4 • n=5 Participants
|
3.8 index
STANDARD_DEVIATION 4.6 • n=7 Participants
|
3.1 index
STANDARD_DEVIATION 3.4 • n=5 Participants
|
|
Total cholesterol
|
4.89 mmol/L
STANDARD_DEVIATION 0.73 • n=5 Participants
|
4.41 mmol/L
STANDARD_DEVIATION 0.75 • n=7 Participants
|
4.65 mmol/L
STANDARD_DEVIATION 0.76 • n=5 Participants
|
|
Triglycerides
|
2.31 mmol/L
STANDARD_DEVIATION 1.25 • n=5 Participants
|
2.19 mmol/L
STANDARD_DEVIATION 0.76 • n=7 Participants
|
2.25 mmol/L
STANDARD_DEVIATION 1.0 • n=5 Participants
|
|
High-density lipoprotein cholesterol (HDL-c)
|
1.13 mmol/L
STANDARD_DEVIATION 0.18 • n=5 Participants
|
1.04 mmol/L
STANDARD_DEVIATION 0.23 • n=7 Participants
|
1.09 mmol/L
STANDARD_DEVIATION 0.21 • n=5 Participants
|
|
Low-density lipoprotein cholesterol (LDL-c)
|
2.69 mmol/L
STANDARD_DEVIATION 0.80 • n=5 Participants
|
2.35 mmol/L
STANDARD_DEVIATION 0.64 • n=7 Participants
|
2.52 mmol/L
STANDARD_DEVIATION 0.73 • n=5 Participants
|
|
Very low-density lipoprotein (VLDL)
|
8.26 mmol/L
STANDARD_DEVIATION 4.48 • n=5 Participants
|
7.86 mmol/L
STANDARD_DEVIATION 2.7 • n=7 Participants
|
8.07 mmol/L
STANDARD_DEVIATION 3.63 • n=5 Participants
|
|
Creatinine
|
70.72 mmol/L
STANDARD_DEVIATION 8.84 • n=5 Participants
|
61.88 mmol/L
STANDARD_DEVIATION 8.84 • n=7 Participants
|
70.36 mmol/L
STANDARD_DEVIATION 8.84 • n=5 Participants
|
|
Alanine aminotransferase (ALT)
|
35.4 U/L
STANDARD_DEVIATION 24.4 • n=5 Participants
|
36.0 U/L
STANDARD_DEVIATION 19.7 • n=7 Participants
|
35.71 U/L
STANDARD_DEVIATION 21.70 • n=5 Participants
|
|
Aspartate aminotransferase (AST)
|
29.0 U/L
STANDARD_DEVIATION 22.4 • n=5 Participants
|
23.1 U/L
STANDARD_DEVIATION 11.3 • n=7 Participants
|
26.08 U/L
STANDARD_DEVIATION 17.68 • n=5 Participants
|
PRIMARY outcome
Timeframe: 90 daysTotal 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
Outcome measures
| Measure |
Momordica Charantia
n=10 Participants
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
|
Placebo
n=10 Participants
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
|
|---|---|---|
|
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
|
0.23 index
Standard Deviation 0.12
|
|
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 725.0
|
309.0 index
Standard Deviation 776.5
|
PRIMARY outcome
Timeframe: 90 daysInsulin sensitivity was calculated at baseline and after 90 days with Matsuda index \[10,000 / √glucose 0' x insulin 0') (mean glucose oral glucose tolerance test (OGTT) x mean insulin OGTT)\]
Outcome measures
| Measure |
Momordica Charantia
n=10 Participants
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
|
Placebo
n=10 Participants
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
|
|---|---|---|
|
Insulin Sensitivity (Matsuda Index) After 90 Days
|
2.1 index
Standard Deviation 1.6
|
2.3 index
Standard Deviation 1.0
|
SECONDARY outcome
Timeframe: 90 daysThe 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
Outcome measures
| Measure |
Momordica Charantia
n=10 Participants
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
|
Placebo
n=10 Participants
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
|
|---|---|---|
|
Fasting Serum Glucose (FSG) After 90 Days
|
7.4 mmol/L
Standard Deviation 2.9
|
7.2 mmol/L
Standard Deviation 2.3
|
SECONDARY outcome
Timeframe: 90 daysA 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
Outcome measures
| Measure |
Momordica Charantia
n=10 Participants
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
|
Placebo
n=10 Participants
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
|
|---|---|---|
|
A1C After 90 Days
|
7.1 percentage
Standard Deviation 1.3
|
7.1 percentage
Standard Deviation 1.1
|
SECONDARY outcome
Timeframe: 90 daysThe 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
Outcome measures
| Measure |
Momordica Charantia
n=10 Participants
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
|
Placebo
n=10 Participants
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
|
|---|---|---|
|
Total Cholesterol After 90 Days
|
4.68 mmol/L
Standard Deviation 1.02
|
4.39 mmol/L
Standard Deviation 0.52
|
SECONDARY outcome
Timeframe: 90 daysThe 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
Outcome measures
| Measure |
Momordica Charantia
n=10 Participants
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
|
Placebo
n=10 Participants
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
|
|---|---|---|
|
Triglycerides After 90 Days
|
1.93 mmol/L
Standard Deviation 0.92
|
2.02 mmol/L
Standard Deviation 0.56
|
SECONDARY outcome
Timeframe: 90 daysThe 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
Outcome measures
| Measure |
Momordica Charantia
n=10 Participants
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
|
Placebo
n=10 Participants
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
|
|---|---|---|
|
High Density Lipoprotein Cholesterol (HDL-c) After 90 Days
|
1.05 mmol/L
Standard Deviation 0.31
|
1.09 mmol/L
Standard Deviation 0.27
|
SECONDARY outcome
Timeframe: 90 daysThe 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
Outcome measures
| Measure |
Momordica Charantia
n=10 Participants
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
|
Placebo
n=10 Participants
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
|
|---|---|---|
|
Low Density Lipoprotein Cholesterol (LDL-c) After 90 Days
|
2.75 mmol/L
Standard Deviation 0.96
|
2.41 mmol/L
Standard Deviation 0.48
|
SECONDARY outcome
Timeframe: 90 daysThe 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
Outcome measures
| Measure |
Momordica Charantia
n=10 Participants
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
|
Placebo
n=10 Participants
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
|
|---|---|---|
|
Very Low Density Lipoprotein After 90 Days
|
6.92 mmol/L
Standard Deviation 3.32
|
7.22 mmol/L
Standard Deviation 1.98
|
SECONDARY outcome
Timeframe: 90 daysThe 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
Outcome measures
| Measure |
Momordica Charantia
n=10 Participants
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
|
Placebo
n=10 Participants
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
|
|---|---|---|
|
Alanine Aminotransferase (ALT) After 90 Days
|
28.1 U/L
Standard Deviation 19.4
|
38.2 U/L
Standard Deviation 18.9
|
SECONDARY outcome
Timeframe: 90 daysThe 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
Outcome measures
| Measure |
Momordica Charantia
n=10 Participants
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
|
Placebo
n=10 Participants
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
|
|---|---|---|
|
Aspartate Aminotransferase (AST) After 90 Days
|
23.9 U/L
Standard Deviation 16.5
|
24.4 U/L
Standard Deviation 6.7
|
SECONDARY outcome
Timeframe: 90 daysThe 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
Outcome measures
| Measure |
Momordica Charantia
n=10 Participants
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
|
Placebo
n=10 Participants
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
|
|---|---|---|
|
Creatinine After 90 Days
|
70.72 mmol/L
Standard Deviation 35.36
|
79.56 mmol/L
Standard Deviation 0.00
|
SECONDARY outcome
Timeframe: 90 daysThe 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
Outcome measures
| Measure |
Momordica Charantia
n=10 Participants
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
|
Placebo
n=10 Participants
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
|
|---|---|---|
|
Systolic Blood Pressure After 90 Days
|
119.6 mmHg
Standard Deviation 9.5
|
115.4 mmHg
Standard Deviation 9.8
|
SECONDARY outcome
Timeframe: 90 daysThe 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
Outcome measures
| Measure |
Momordica Charantia
n=10 Participants
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
|
Placebo
n=10 Participants
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
|
|---|---|---|
|
Diastolic Blood Pressure After 90 Days
|
75.1 mmHg
Standard Deviation 6.5
|
72.6 mmHg
Standard Deviation 4.7
|
SECONDARY outcome
Timeframe: 90 daysThe 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.
Outcome measures
| Measure |
Momordica Charantia
n=10 Participants
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
|
Placebo
n=10 Participants
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
|
|---|---|---|
|
Body Weight (BW) After 90 Days
|
78.0 kg
Standard Deviation 9.2
|
73.4 kg
Standard Deviation 10.8
|
SECONDARY outcome
Timeframe: 90 daysThe 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
Outcome measures
| Measure |
Momordica Charantia
n=10 Participants
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
|
Placebo
n=10 Participants
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
|
|---|---|---|
|
Body Mass Index (BMI) After 90 Days
|
28.3 kg/m^2
Standard Deviation 1.9
|
28.9 kg/m^2
Standard Deviation 3.6
|
SECONDARY outcome
Timeframe: 90 daysFat 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)
Outcome measures
| Measure |
Momordica Charantia
n=10 Participants
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
|
Placebo
n=10 Participants
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
|
|---|---|---|
|
Fat Mass After 90 Days
|
36.3 percentage
Standard Deviation 7.6
|
35.8 percentage
Standard Deviation 6.9
|
SECONDARY outcome
Timeframe: 90 daysThe 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
Outcome measures
| Measure |
Momordica Charantia
n=10 Participants
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
|
Placebo
n=10 Participants
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
|
|---|---|---|
|
Waist Circumference (WC) After 90 Days
|
104 cm
Standard Deviation 11
|
98 cm
Standard Deviation 10
|
SECONDARY outcome
Timeframe: 90 daysThe 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%
Outcome measures
| Measure |
Momordica Charantia
n=10 Participants
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
|
Placebo
n=10 Participants
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
|
|---|---|---|
|
2-h Serum Glucose After 90 Days
|
13.2 mmol/L
Standard Deviation 4.3
|
14.3 mmol/L
Standard Deviation 4.3
|
SECONDARY outcome
Timeframe: 90 daysThe polygonal formula was used to calculate area under the curve (AUC) of glucose at baseline and after 90 days
Outcome measures
| Measure |
Momordica Charantia
n=10 Participants
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
|
Placebo
n=10 Participants
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
|
|---|---|---|
|
AUC-glucose After 90 Days
|
1576 mmol/L/min
Standard Deviation 391
|
1663 mmol/L/min
Standard Deviation 363
|
SECONDARY outcome
Timeframe: 90 daysThe polygonal formula was used to calculate area under the curve (AUC) of insulin at baseline and after 90 days
Outcome measures
| Measure |
Momordica Charantia
n=10 Participants
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
|
Placebo
n=10 Participants
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
|
|---|---|---|
|
AUC-insulin After 90 Days
|
65256 pmol/L/min
Standard Deviation 42720
|
41310 pmol/L/min
Standard Deviation 20292
|
Adverse Events
Momordica Charantia
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Momordica Charantia
n=12 participants at risk
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
|
Placebo
n=12 participants at risk
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
|
|---|---|---|
|
Nervous system disorders
Headache
|
33.3%
4/12 • Adverse events were collected throughout the 90 days of the study
|
25.0%
3/12 • Adverse events were collected throughout the 90 days of the study
|
|
Gastrointestinal disorders
Constipation
|
8.3%
1/12 • Adverse events were collected throughout the 90 days of the study
|
16.7%
2/12 • Adverse events were collected throughout the 90 days of the study
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/12 • Adverse events were collected throughout the 90 days of the study
|
16.7%
2/12 • Adverse events were collected throughout the 90 days of the study
|
|
Nervous system disorders
Dizziness
|
33.3%
4/12 • Adverse events were collected throughout the 90 days of the study
|
8.3%
1/12 • Adverse events were collected throughout the 90 days of the study
|
|
Gastrointestinal disorders
Nausea
|
16.7%
2/12 • Adverse events were collected throughout the 90 days of the study
|
8.3%
1/12 • Adverse events were collected throughout the 90 days of the study
|
|
Gastrointestinal disorders
Vomiting
|
8.3%
1/12 • Adverse events were collected throughout the 90 days of the study
|
0.00%
0/12 • Adverse events were collected throughout the 90 days of the study
|
Additional Information
Dra. Esperanza Martínez Abundis
Institute of Experimental and Clinical Therapeutics
Phone: +52-33-10-58-52-00
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place