Hypoglycemic Efficacy of Greenyn Momordica Charantia Extracts in Diabetic Subjects

Study Overview
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Brief Summary
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This is a randomized, double-blind, placebo-controlled, add-on clinical trial to evaluate the efficacy and safety of Momordica Charantia extracts taken orally for 3 months by subjects with type 2 diabetes. A total of 40 subjects who meet the inclusion criteria and give written consent will be randomly assigned to (A) Momordica charantia extracts group (600mg/day), or (B) Placebo group (Starch 600mg/day) with 20 subjects for each group. Major enrollment criteria include: (1)Subjects have confirmed type 2 diabetes and fail to reach the treatment goal (fasting glucose 140-270mg/dL and hemoglobin A1c (HbA1c) 7-10%) after stable use of 1-3 oral hypoglycemic drugs for 3 months; (2)Subjects have stable diabetes mellitus (DM) history with fasting glucose 140-270mg/dL and HbA1c 7-10% and refuse to use oral medications. Efficacy outcomes include the changes in fasting glucose, Hb1Ac, and insulin sensitivity, and safety assessments include liver and kidney function, and complains made by subjects after the initiation of the investigational products (IP).

Detailed Description
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This study aims to investigate the hypoglycemic efficacy of oral Momordica Charantia extracts containing mcIRBP manufactured by Greenyn Biotechnology. The study objectives include: To evaluate the changes in fasting glucose, hemoglobin A1c (Hb1Ac), glucose tolerance test, and insulin sensitivity after taking the investigational products (IP) orally for 3 months. To evaluate the safety of the IP, including the liver and kidney function, and complains made by subjects after the initiation of the IP. This is a randomized, double-blind, placebo-controlled, add-on clinical trial to evaluate the efficacy and safety of Momordica Charantia extracts taken orally for 3 months by subjects with type 2 diabetes. A total of 40 subjects who meet the enrollment criteria and give written consent will be randomly assigned to (A) Momordica charantia extracts group (600mg/day), or (B) Placebo group (Starch 600mg/day) with 20 subjects for each group. Subjects will take the IP for 12 weeks and the hypoglycemic medications taken by the subjects before enrollment will remain stable over the study period. Study procedures for each visit: Visit 1: Day 0 Obtain signed informed consent form Assess vital signs and record concomitant medication Lab tests: Fasting glucose, HbA1c, liver function, kidney function, hemoglobin (Hb) Visit 2: <7 day from Visit 1 Confirm eligibility and randomization Initiation of treatment Lab tests: Fasting glucose, HbA1c, insulin, lipids, total protein, uric acid, oral glucose tolerance test (OGTT), ketone body Measure height, weight, thigh circumference, waist and hip circumference Record concomitant medication Visit 3: 1 month after Visit 1 Measure vital signs Lab tests: Fasting glucose, HbA1c, lipids, ketone body IP Accountability and dispense IP Records adverse events Visit 4: 3 months after Visit 1 Lab tests: Fasting glucose, HbA1c, liver function, kidney function, Hb, insulin, lipids, total protein, uric acid, OGTT, ketone body Measure vital signs, height, weight, thigh circumference, waist and hip circumference IP Accountability and dispense IP Records adverse events Statistical Analysis All randomized subjects will be entered for efficacy analysis dataset, and subjects who receives at least one dose of IP will be included for safety analysis. Mean and standard deviation will be used for data presentation, and changes from baseline for all assessments will be plotted against time. Paired t test will be performed for the before and after treatment comparison within group, and 2-independent t test will be used to compare the changes from baseline between the two groups. All statistical analyses will be conducted by using SPSS v.18 (SPSS Inc., Chicago, IL, USA) and p<0.05 is considered to have statistical significance.

Official Title
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A Randomized, Double-blind, Placebo-controlled Trial to Evaluate the Hypoglycemic Efficacy of Greenyn Momordica Charantia Extracts in Diabetic Subjects

Conditions
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Diabetes Mellitus, Type 2

Intervention / Treatment
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* Dietary Supplement: Greenyn Momordica charantia extracts
* Dietary Supplement: Placebo control


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 20 to 80 years of age Newly diagnosis with type 2 diabetes based on a fasting plasma glucose(FPG)>=126 mg/dL or 2-5 postprandial glucose levels during 75-g OGTT>=200 mg/dL The person who take 1-3 or more medicine to treat hyperglycemic but not very effective.(Fasting glucose:140-270mg/dL，HbA1c 7-10%) Exclusion Criteria: Serum creatinine > 1.8mg/dL Serum ALT, AST, total bilirubin or alkaline phosphatase higher than 2.5 times of the upper normal range Anemia (Hb Male: < 11g/dL;Female: < 10g/dL) Pregnancy or Lactation Severe angina Moderate-severe heart failure with left ventricular hypertrophy BMI<18 or >38 a body weight variation more than 10% during the screening period. Dietary habits change in one months or body weight change >10% Life expectancy is low than 6 months be allergy to bitter melon Severe long-term diabetic complications such as diabetic retinopathy,diabetic neuropathy,systemic orthostatic hypotension,urinary retention,foot ulcers or gastric stasis Acute disease Participation in another clinical trial within 30 days of screening

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Momordica charantia<br>Subjects will take the capsule of Greenyn Momordica charantia extracts 600 mg/day orally for three months. | Dietary Supplement: Greenyn Momordica charantia extracts<br>* Extracts from Momordica charantia containing Momordica charantia insulin receptor binding protein (mcIRBP)<br>|
| Placebo Comparator: Placebo control<br>Subjects will take the capsule of Placebo 600 mg/day orally for three months. | Dietary Supplement: Placebo control<br>* Starch<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fasting glucose | Fasting glucose in milligram per deciliter | from baseline at 3 month | 
| Glycated hemoglobin | Glycated hemoglobin in percentage | from baseline at 3 month | 
| Fasting insulin | Fasting insulin in milliunit per milliliter | from baseline at 3 month | 
| Oral Glucose Tolerance Test | Oral Glucose Tolerance Test in milligram per deciliter | from baseline at 3 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total cholesterol | Total cholesterol in milligram per deciliter | from baseline at 3 month | 
| L.D.L.cholesterol | L.D.L.cholesterol in milligram per deciliter | from baseline at 3 month | 
| H.D.L.cholesterol | H.D.L.cholesterol in milligram per deciliter | from baseline at 3 month | 
| Body mass index(BMI) | BMI in kg/m^2 | from baseline at 3 month | 
| Body fat | Body fat in percentage | from baseline at 3 month | 
| Waist circumference | Waist circumference in centimeter | from baseline at 3 month | 
| Hip circumference | Hip circumference in centimeter | from baseline at 3 month | 
| Upper arm circumference | Upper arm circumference in centimeter | from baseline at 3 month | 
| Ketone body | Ketone body in positive or negative | from baseline at 3 month | 
| total protein | total protein in gram per deciliter | from baseline at 3 month | 
| Blood pressure | Blood pressure in millimeter of mercury | from baseline at 3 month | 
| Aspartate Aminotransferase (AST) | Aspartate Aminotransferase (AST) in IU per liter | from baseline at 3 month | 
| Alanine Aminotransferase (ALT) | Alanine Aminotransferase (ALT) in IU per liter | from baseline at 3 month | 
| Creatinine | Creatinine in milligram per deciliter | from baseline at 3 month | 
| Blood urea nitrogen (BUN) | BUN in milligram per deciliter | from baseline at 3 month | 
| Uric Acid(UA) | UA in milligram per deciliter | from baseline at 3 month | 
| Hemoglobin(Hb) | Hb in gram per deciliter | from baseline at 3 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diabetes, Bitter melon(Momordica charantia), Insulin sensitivity