Phase 2
N=24
Effect of Momordica Charantia Administration on Type 2 Diabetes Mellitus, Insulin Sensitivity and Insulin Secretion
Diabetes Mellitus Type 2
Bottom Line
View on ClinicalTrials.gov: NCT02397447 ↗Enrolled (actual)
24
Serious AEs
0.0%
Results posted
Oct 2020
Primary outcome: Primary: Total and First Phase of Insulin Secretion (Insulinogenic Index and Stumvoll Index) After 90 Days — 0.41; 0.23; 1135.7; 309.0 index
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Momordica charantia (Drug); Placebo (Drug)
- Age
- Adult · 35+ yrs
- Sex
- All
- Sponsor
- University of Guadalajara
- Primary completion
- Nov 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Total and First Phase of Insulin Secretion (Insulinogenic Index and Stumvoll Index) After 90 Days |
0.41; 0.23; 1135.7; 309.0 | — |
| PRIMARY Insulin Sensitivity (Matsuda Index) After 90 Days |
2.1; 2.3 | — |
| SECONDARY Fasting Serum Glucose (FSG) After 90 Days |
7.4; 7.2 | — |
| SECONDARY A1C After 90 Days |
7.1; 7.1 | — |
| SECONDARY Total Cholesterol After 90 Days |
4.68; 4.39 | — |
| SECONDARY Triglycerides After 90 Days |
1.93; 2.02 | — |
| SECONDARY High Density Lipoprotein Cholesterol (HDL-c) After 90 Days |
1.05; 1.09 | — |
| SECONDARY Low Density Lipoprotein Cholesterol (LDL-c) After 90 Days |
2.75; 2.41 | — |
| SECONDARY Very Low Density Lipoprotein After 90 Days |
6.92; 7.22 | — |
| SECONDARY Alanine Aminotransferase (ALT) After 90 Days |
28.1; 38.2 | — |
| SECONDARY Aspartate Aminotransferase (AST) After 90 Days |
23.9; 24.4 | — |
| SECONDARY Creatinine After 90 Days |
70.72; 79.56 | — |
| SECONDARY Systolic Blood Pressure After 90 Days |
119.6; 115.4 | — |
| SECONDARY Diastolic Blood Pressure After 90 Days |
75.1; 72.6 | — |
| SECONDARY Body Weight (BW) After 90 Days |
78.0; 73.4 | — |
| SECONDARY Body Mass Index (BMI) After 90 Days |
28.3; 28.9 | — |
| SECONDARY Fat Mass After 90 Days |
36.3; 35.8 | — |
| SECONDARY Waist Circumference (WC) After 90 Days |
104; 98 | — |
| SECONDARY 2-h Serum Glucose After 90 Days |
13.2; 14.3 | — |
| SECONDARY AUC-glucose After 90 Days |
1576; 1663 | — |
| SECONDARY AUC-insulin After 90 Days |
65256; 41310 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Diagnosis of diabetes mellitus type 2 according to the criteria of the American Diabetes Association ( = 240mg/dl, triglycerides >=400mg/dl, glomerular filtration rate =2.5 the upper normal limit
Data sourced from ClinicalTrials.gov (NCT02397447). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.