Hypoglycemic Efficacy of Greenyn Momordica Charantia Extracts in Diabetic Subjects

Not Applicable

Completed

• Conditions: Diabetes Mellitus, Type 2
• Interventions: Dietary Supplement: Greenyn Momordica charantia extracts; Dietary Supplement: Placebo control

• Registration Number: NCT03151837
• Lead Sponsor: Chung Shan Medical University

Brief Summary

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

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 Timeline

• Study First Submitted: 2017-04-26
• Study Start: 2017-05-10
• Study First Submitted QC: 2017-05-11
• Study First Posted: 2017-05-12
• Primary Completion: 2017-12-16
• Study Completion: 2017-12-16
• Status Verified: 2018-01
• Last Update Submitted: 2018-01-23
• Last Update Posted: 2018-01-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Momordica charantia	Greenyn Momordica charantia extracts	Subjects will take the capsule of Greenyn Momordica charantia extracts 600 mg/day orally for three months.
Placebo control	Placebo control	Subjects will take the capsule of Placebo 600 mg/day orally for three months.

Primary Outcome Measures

Name	Time	Method
Fasting glucose	from baseline at 3 month	Fasting glucose in milligram per deciliter
Glycated hemoglobin	from baseline at 3 month	Glycated hemoglobin in percentage
Fasting insulin	from baseline at 3 month	Fasting insulin in milliunit per milliliter
Oral Glucose Tolerance Test	from baseline at 3 month	Oral Glucose Tolerance Test in milligram per deciliter

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Chung Shan Medical University Hospital; 🇨🇳 Taichung, Taiwan