Clinical trial NCT02397447: Effect of Momordica Charantia Administration on Type 2 Diabetes Mellitus, Insulin Sensitivity and Insulin Secretion
Official title: Effect of Momordica Charantia Administration on Insulin Sensitivity and Insulin Secretion in Patients With Type 2 Diabetes Mellitus, Without Pharmacological Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Diabetes Mellitus Type 2
Keywords: Momordica Charantia
Insulin secretion
Insulin sensitivity
Lead sponsor: University of Guadalajara
Sponsor class: OTHER
First posted: 2015-03-25
Enrollment: 24
Sex: ALL
Minimum age (years): 35
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Total and First Phase of Insulin Secretion (Insulinogenic Index and Stumvoll Index) After 90 Days
timeFrame: 90 days
measure: Insulin Sensitivity (Matsuda Index) After 90 Days
timeFrame: 90 days
Secondary outcomes:
measure: Fasting Serum Glucose (FSG) After 90 Days
timeFrame: 90 days
measure: A1C After 90 Days
timeFrame: 90 days
measure: Total Cholesterol After 90 Days
timeFrame: 90 days
measure: Triglycerides After 90 Days
timeFrame: 90 days
measure: High Density Lipoprotein Cholesterol (HDL-c) After 90 Days
timeFrame: 90 days
measure: Low Density Lipoprotein Cholesterol (LDL-c) After 90 Days
timeFrame: 90 days
measure: Very Low Density Lipoprotein After 90 Days
timeFrame: 90 days
measure: Alanine Aminotransferase (ALT) After 90 Days
timeFrame: 90 days
measure: Aspartate Aminotransferase (AST) After 90 Days
timeFrame: 90 days
measure: Creatinine After 90 Days
timeFrame: 90 days
measure: Systolic Blood Pressure After 90 Days
timeFrame: 90 days
measure: Diastolic Blood Pressure After 90 Days
timeFrame: 90 days
measure: Body Weight (BW) After 90 Days
timeFrame: 90 days
measure: Body Mass Index (BMI) After 90 Days
timeFrame: 90 days
measure: Fat Mass After 90 Days
timeFrame: 90 days
measure: Waist Circumference (WC) After 90 Days
timeFrame: 90 days
measure: 2-h Serum Glucose After 90 Days
timeFrame: 90 days
measure: AUC-glucose After 90 Days
timeFrame: 90 days
measure: AUC-insulin After 90 Days
timeFrame: 90 days
Other outcomes:
Locations:
city: Guadalajara
country: Mexico
facility: Institute of Experimental and Clinical Therapeutics (INTEC), CUCS, University of Guadalajara
state: Jalisco
Study officials:
affiliation: Institute of Experimental and Clinical Therapeutics (INTEC), CUCS, University of Guadalajara
name: Esperanza Martínez Abundis, PhD Science
role: PRINCIPAL_INVESTIGATOR
References: