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CompletedNCT02397447Updated Oct 22, 2020Results posted

Effect of Momordica Charantia Administration on Type 2 Diabetes Mellitus, Insulin Sensitivity and Insulin Secretion

A Phase 2 interventional study of Momordica charantia and Placebo in Diabetes Mellitus Type 2, sponsored by University of Guadalajara. Completed at 1 site in Mexico. Open to participants aged 35 Years to 60 Years. Per ClinicalTrials.gov, last updated 2020-10-22.

Sponsored by University of Guadalajara · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
24
Allocation
Randomized
Ages
35 Years to 60 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Diabetes Mellitus Type 2

Keywords

  • Momordica Charantia
  • Insulin secretion
  • Insulin sensitivity
03

In context

Diabetes Mellitus

10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.

This study's enrollment of 24 is below the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.

Browse Diabetes Mellitus studies →

Lead sponsor

University of Guadalajara is the lead sponsor of 94 studies on the registry; 18 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
35 Years to 60 Years
Sexes eligible
All
Accepts 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

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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
24 participants (actual)

Study arms

  • Experimental
    Momordica charantia

    Two 500 mg capsules of Momordica Charantia twice daily before breakfast and dinner for 90 days

    Drug: Momordica charantia

  • Placebo comparator
    Placebo

    Two 500 mg capsules of calcined magnesia twice daily before breakfast and dinner for 90 days

    Drug: Placebo

Interventions

  • DrugMomordica charantia

    Momordica Charantia: 2000 mg per day for three months

    Also known as: Bitter gourd, karela, balsam-pear

  • DrugPlacebo

    Placebo: 2000 mg per day for three months

    Also known as: Calcined magnesia

06

What researchers measure

Primary outcomes

  1. 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

  2. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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

  12. 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

  13. 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

  14. 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

  15. 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

  16. 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

  17. 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

  18. 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

  19. 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

07

Results

Posted Oct 22, 2020

Participant flow

Participant flow — Overall Study
MilestoneMomordica CharantiaPlacebo
Started1212
Completed1010
Not completed22
Withdrew: Lost to follow-up22

Outcome measures

PrimaryTotal 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
Reported as:
Mean · index
Total and First Phase of Insulin Secretion (Insulinogenic Index and Stumvoll Index) After 90 Days
indexMomordica CharantiaPlacebo
Total insulin secretion (Insulinogenic index)0.41 ± 0.290.23 ± 0.12
First Phase of Insulin Secretion (Stumvoll index)1135.7 ± 725.0309.0 ± 776.5
PrimaryInsulin 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
Reported as:
Mean · index
Insulin Sensitivity (Matsuda Index) After 90 Days
indexMomordica CharantiaPlacebo
Insulin Sensitivity (Matsuda Index) After 90 Days2.1 ± 1.62.3 ± 1.0
SecondaryFasting 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
Reported as:
Mean · mmol/L
Fasting Serum Glucose (FSG) After 90 Days
mmol/LMomordica CharantiaPlacebo
Fasting Serum Glucose (FSG) After 90 Days7.4 ± 2.97.2 ± 2.3
SecondaryA1C 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
Reported as:
Mean · percentage
A1C After 90 Days
percentageMomordica CharantiaPlacebo
A1C After 90 Days7.1 ± 1.37.1 ± 1.1
SecondaryTotal 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
Reported as:
Mean · mmol/L
Total Cholesterol After 90 Days
mmol/LMomordica CharantiaPlacebo
Total Cholesterol After 90 Days4.68 ± 1.024.39 ± 0.52
SecondaryTriglycerides 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
Reported as:
Mean · mmol/L
Triglycerides After 90 Days
mmol/LMomordica CharantiaPlacebo
Triglycerides After 90 Days1.93 ± 0.922.02 ± 0.56
SecondaryHigh 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
Reported as:
Mean · mmol/L
High Density Lipoprotein Cholesterol (HDL-c) After 90 Days
mmol/LMomordica CharantiaPlacebo
High Density Lipoprotein Cholesterol (HDL-c) After 90 Days1.05 ± 0.311.09 ± 0.27
SecondaryLow 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
Reported as:
Mean · mmol/L
Low Density Lipoprotein Cholesterol (LDL-c) After 90 Days
mmol/LMomordica CharantiaPlacebo
Low Density Lipoprotein Cholesterol (LDL-c) After 90 Days2.75 ± 0.962.41 ± 0.48
SecondaryVery 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
Reported as:
Mean · mmol/L
Very Low Density Lipoprotein After 90 Days
mmol/LMomordica CharantiaPlacebo
Very Low Density Lipoprotein After 90 Days6.92 ± 3.327.22 ± 1.98
SecondaryAlanine 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
Reported as:
Mean · U/L
Alanine Aminotransferase (ALT) After 90 Days
U/LMomordica CharantiaPlacebo
Alanine Aminotransferase (ALT) After 90 Days28.1 ± 19.438.2 ± 18.9
SecondaryAspartate 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
Reported as:
Mean · U/L
Aspartate Aminotransferase (AST) After 90 Days
U/LMomordica CharantiaPlacebo
Aspartate Aminotransferase (AST) After 90 Days23.9 ± 16.524.4 ± 6.7
SecondaryCreatinine 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
Reported as:
Mean · mmol/L
Creatinine After 90 Days
mmol/LMomordica CharantiaPlacebo
Creatinine After 90 Days70.72 ± 35.3679.56 ± 0.00
SecondarySystolic 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
Reported as:
Mean · mmHg
Systolic Blood Pressure After 90 Days
mmHgMomordica CharantiaPlacebo
Systolic Blood Pressure After 90 Days119.6 ± 9.5115.4 ± 9.8
SecondaryDiastolic 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
Reported as:
Mean · mmHg
Diastolic Blood Pressure After 90 Days
mmHgMomordica CharantiaPlacebo
Diastolic Blood Pressure After 90 Days75.1 ± 6.572.6 ± 4.7
SecondaryBody 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
Reported as:
Mean · kg
Body Weight (BW) After 90 Days
kgMomordica CharantiaPlacebo
Body Weight (BW) After 90 Days78.0 ± 9.273.4 ± 10.8
SecondaryBody 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
Reported as:
Mean · kg/m^2
Body Mass Index (BMI) After 90 Days
kg/m^2Momordica CharantiaPlacebo
Body Mass Index (BMI) After 90 Days28.3 ± 1.928.9 ± 3.6
SecondaryFat 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
Reported as:
Mean · percentage
Fat Mass After 90 Days
percentageMomordica CharantiaPlacebo
Fat Mass After 90 Days36.3 ± 7.635.8 ± 6.9
SecondaryWaist 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
Reported as:
Mean · cm
Waist Circumference (WC) After 90 Days
cmMomordica CharantiaPlacebo
Waist Circumference (WC) After 90 Days104 ± 1198 ± 10
Secondary2-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
Reported as:
Mean · mmol/L
2-h Serum Glucose After 90 Days
mmol/LMomordica CharantiaPlacebo
2-h Serum Glucose After 90 Days13.2 ± 4.314.3 ± 4.3
SecondaryAUC-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
Reported as:
Mean · mmol/L/min
AUC-glucose After 90 Days
mmol/L/minMomordica CharantiaPlacebo
AUC-glucose After 90 Days1576 ± 3911663 ± 363
SecondaryAUC-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
Reported as:
Mean · pmol/L/min
AUC-insulin After 90 Days
pmol/L/minMomordica CharantiaPlacebo
AUC-insulin After 90 Days65256 ± 4272041310 ± 20292

Adverse events

Collected over Adverse events were collected throughout the 90 days of the study. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Momordica Charantia—0/12 (0%)4/12 (33.3%)
Placebo—0/12 (0%)3/12 (25%)
Most frequent other events
Most frequent other events
EventMomordica CharantiaPlacebo
HeadacheNervous system disorders4/123/12
DizzinessNervous system disorders4/121/12
ConstipationGastrointestinal disorders1/122/12
Abdominal distensionGastrointestinal disorders0/122/12
NauseaGastrointestinal disorders2/121/12
VomitingGastrointestinal disorders1/120/12

Baseline characteristics

Age, Continuous
Age, Continuous(years)Momordica CharantiaPlaceboTotal
Mean50.1 ± 7.347 ± 7.448.6 ± 7.4
Sex: Female, Male
Sex: Female, Male(Participants)Momordica CharantiaPlaceboTotal
Female7916
Male538
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Momordica CharantiaPlaceboTotal
Hispanic or Latino121224
Not Hispanic or Latino000
Unknown or Not Reported000
Region of Enrollment
Region of Enrollment(participants)Momordica CharantiaPlaceboTotal
Mexico121224
Body weight (BW)
Body weight (BW)(kg)Momordica CharantiaPlaceboTotal
Mean79.4 ± 9.273.6 ± 11.176.5 ± 10.4
Body mass index (BMI)
Body mass index (BMI)(kg/m^2)Momordica CharantiaPlaceboTotal
Mean29.1 ± 2.428.8 ± 3.928.9 ± 3.2
Fat mass
Fat mass(body fat percentage)Momordica CharantiaPlaceboTotal
Mean36.7 ± 7.835.2 ± 8.136.0 ± 7.8
Waist circumference (WC)
Waist circumference (WC)(cm)Momordica CharantiaPlaceboTotal
Mean106 ± 1297 ± 11101.9 ± 12.1

18 further baseline measures are reported on the registry.

08

Study locations

1 site
  • Institute of Experimental and Clinical Therapeutics (INTEC), CUCS, University of Guadalajara
    Guadalajara, Jalisco 44340, Mexico
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 22, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02397447
Lead sponsor
University of Guadalajara
Responsible party
Esperanza Martínez-Abundis (PhD. Esperanza Martínez-Abundis, University of Guadalajara) — Principal investigator
First posted
Mar 25, 2015
Start date
Mar 2013
Primary completion
Nov 2015
Completion
Nov 2015
Results posted
Oct 22, 2020
Last update
Oct 22, 2020

Study contacts

Esperanza Martínez Abundis, PhD Science
principal investigator · Institute of Experimental and Clinical Therapeutics (INTEC), CUCS, University of Guadalajara

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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