Hypoglycemic Efficacy of Greenyn Momordica Charantia Extracts in Diabetic Subjects

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

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).

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus, Type 2
• Intervention / Treatment: Dietary supplement: Greenyn Momordica charantia extracts; Dietary supplement: Placebo control

Detailed Description

This study aims to investigate the hypoglycemic efficacy of oral Momordica Charantia extracts containing mcIRBP manufactured by Greenyn Biotechnology. The study objectives include:

1. 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.
2. 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

1. Obtain signed informed consent form
2. Assess vital signs and record concomitant medication
3. Lab tests: Fasting glucose, HbA1c, liver function, kidney function, hemoglobin (Hb)

Visit 2: <7 day from Visit 1

1. Confirm eligibility and randomization
2. Initiation of treatment
3. Lab tests: Fasting glucose, HbA1c, insulin, lipids, total protein, uric acid, oral glucose tolerance test (OGTT), ketone body
4. Measure height, weight, thigh circumference, waist and hip circumference
5. Record concomitant medication

Visit 3: 1 month after Visit 1

1. Measure vital signs
2. Lab tests: Fasting glucose, HbA1c, lipids, ketone body
3. IP Accountability and dispense IP
4. Records adverse events

Visit 4: 3 months after Visit 1

1. Lab tests: Fasting glucose, HbA1c, liver function, kidney function, Hb, insulin, lipids, total protein, uric acid, OGTT, ketone body
2. Measure vital signs, height, weight, thigh circumference, waist and hip circumference
3. IP Accountability and dispense IP
4. 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.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Taichung, Taiwan, 40201
    • Chung Shan Medical University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Momordica charantia; Subjects will take the capsule of Greenyn Momordica charantia extracts 600 mg/day orally for three months.	Dietary supplement: Greenyn Momordica charantia extracts; Extracts from Momordica charantia containing Momordica charantia insulin receptor binding protein (mcIRBP)
PLACEBO_COMPARATOR: Placebo control; Subjects will take the capsule of Placebo 600 mg/day orally for three months.	Dietary supplement: Placebo control; Starch

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Chung Shan Medical University
• Investigators: Principal Investigator: Chien-Ning Huang, Ph.D., Chung Shan Medical University

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 10, 2017
• Primary Completion (ACTUAL): December 16, 2017
• Study Completion (ACTUAL): December 16, 2017

Study Registration Dates

• First Submitted: April 26, 2017
• First Submitted That Met QC Criteria: May 11, 2017
• First Posted (ACTUAL): May 12, 2017

Study Record Updates

• Last Update Posted (ACTUAL): January 25, 2018
• Last Update Submitted That Met QC Criteria: January 23, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Keywords: Diabetes; Insulin sensitivity; Bitter melon(Momordica charantia)
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: CS16148

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No