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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02397447
• Date of registration: 10/03/2015
• Prospective Registration: No
• Primary sponsor: University of Guadalajara
• Public title: Effect of Momordica Charantia Administration on Type 2 Diabetes Mellitus, Insulin Sensitivity and Insulin Secretion
• Scientific title: Effect of Momordica Charantia Administration on Insulin Sensitivity and Insulin Secretion in Patients With Type 2 Diabetes Mellitus, Without Pharmacological Treatment
• Date of first enrolment: March 2013
• Target sample size: 24
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02397447
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
• Phase: Phase 2

Countries of recruitment

Mexico

Contacts

• Name: Esperanza Martínez Abundis, PhD Science
• Affiliation: Institute of Experimental and Clinical Therapeutics (INTEC), CUCS, University of Guadalajara

Key inclusion & exclusion criteria

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



Age minimum: 35 Years
Age maximum: 60 Years
Gender: All

Health Condition(s) or Problem(s) studied

Diabetes Mellitus Type 2

Intervention(s)

Drug: Momordica charantia

Drug: Placebo

Primary Outcome(s)

Insulin Sensitivity (Matsuda Index) After 90 Days [Time Frame: 90 days]

Total and First Phase of Insulin Secretion (Insulinogenic Index and Stumvoll Index) After 90 Days [Time Frame: 90 days]

Secondary Outcome(s)

Creatinine After 90 Days [Time Frame: 90 days]

Systolic Blood Pressure After 90 Days [Time Frame: 90 days]

Triglycerides After 90 Days [Time Frame: 90 days]

Waist Circumference (WC) After 90 Days [Time Frame: 90 days]

Aspartate Aminotransferase (AST) After 90 Days [Time Frame: 90 days]

AUC-insulin After 90 Days [Time Frame: 90 days]

Body Mass Index (BMI) After 90 Days [Time Frame: 90 days]

Fasting Serum Glucose (FSG) After 90 Days [Time Frame: 90 days]

Very Low Density Lipoprotein After 90 Days [Time Frame: 90 days]

Diastolic Blood Pressure After 90 Days [Time Frame: 90 days]

Body Weight (BW) After 90 Days [Time Frame: 90 days]

Fat Mass After 90 Days [Time Frame: 90 days]

Low Density Lipoprotein Cholesterol (LDL-c) After 90 Days [Time Frame: 90 days]

2-h Serum Glucose After 90 Days [Time Frame: 90 days]

A1C After 90 Days [Time Frame: 90 days]

Alanine Aminotransferase (ALT) After 90 Days [Time Frame: 90 days]

Total Cholesterol After 90 Days [Time Frame: 90 days]

AUC-glucose After 90 Days [Time Frame: 90 days]

High Density Lipoprotein Cholesterol (HDL-c) After 90 Days [Time Frame: 90 days]

Secondary ID(s)

MCHDM2

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 22/10/2020
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02397447