Clinical trial NCT03151837: Hypoglycemic Efficacy of Greenyn Momordica Charantia Extracts in Diabetic Subjects
Official title: A Randomized, Double-blind, Placebo-controlled Trial to Evaluate the Hypoglycemic Efficacy of Greenyn Momordica Charantia Extracts in Diabetic Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Keywords: Diabetes
Bitter melon(Momordica charantia)
Insulin sensitivity
Lead sponsor: Chung Shan Medical University
Sponsor class: OTHER
First posted: 2017-05-12
Enrollment: 40
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Fasting glucose
timeFrame: from baseline at 3 month
measure: Glycated hemoglobin
timeFrame: from baseline at 3 month
measure: Fasting insulin
timeFrame: from baseline at 3 month
measure: Oral Glucose Tolerance Test
timeFrame: from baseline at 3 month
Secondary outcomes:
measure: Total cholesterol
timeFrame: from baseline at 3 month
measure: L.D.L.cholesterol
timeFrame: from baseline at 3 month
measure: H.D.L.cholesterol
timeFrame: from baseline at 3 month
measure: Body mass index(BMI)
timeFrame: from baseline at 3 month
measure: Body fat
timeFrame: from baseline at 3 month
measure: Waist circumference
timeFrame: from baseline at 3 month
measure: Hip circumference
timeFrame: from baseline at 3 month
measure: Upper arm circumference
timeFrame: from baseline at 3 month
measure: Ketone body
timeFrame: from baseline at 3 month
measure: total protein
timeFrame: from baseline at 3 month
measure: Blood pressure
timeFrame: from baseline at 3 month
measure: Aspartate Aminotransferase (AST)
timeFrame: from baseline at 3 month
measure: Alanine Aminotransferase (ALT)
timeFrame: from baseline at 3 month
measure: Creatinine
timeFrame: from baseline at 3 month
measure: Blood urea nitrogen (BUN)
timeFrame: from baseline at 3 month
measure: Uric Acid(UA)
timeFrame: from baseline at 3 month
measure: Hemoglobin(Hb)
timeFrame: from baseline at 3 month
Other outcomes:
Locations:
city: Taichung
country: Taiwan
facility: Chung Shan Medical University Hospital
Study officials:
affiliation: Chung Shan Medical University
name: Chien-Ning Huang, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: