Diabetes Mellitus, Type 2
Conditions
Keywords
Diabetes, Bitter melon(Momordica charantia), Insulin sensitivity
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.
Interventions
DIETARY_SUPPLEMENTGreenyn Momordica charantia extracts
Extracts from Momordica charantia containing Momordica charantia insulin receptor binding protein (mcIRBP)
DIETARY_SUPPLEMENTPlacebo control
Starch
Sponsors
Chung Shan Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Ketone body | from baseline at 3 month | Ketone body in positive or negative |
| Body mass index(BMI) | from baseline at 3 month | BMI in kg/m\^2 |
| Body fat | from baseline at 3 month | Body fat in percentage |
| Total cholesterol | from baseline at 3 month | Total cholesterol in milligram per deciliter |
| L.D.L.cholesterol | from baseline at 3 month | L.D.L.cholesterol in milligram per deciliter |
| H.D.L.cholesterol | from baseline at 3 month | H.D.L.cholesterol in milligram per deciliter |
| total protein | from baseline at 3 month | total protein in gram per deciliter |
| Aspartate Aminotransferase (AST) | from baseline at 3 month | Aspartate Aminotransferase (AST) in IU per liter |
| Alanine Aminotransferase (ALT) | from baseline at 3 month | Alanine Aminotransferase (ALT) in IU per liter |
| Creatinine | from baseline at 3 month | Creatinine in milligram per deciliter |
| Blood urea nitrogen (BUN) | from baseline at 3 month | BUN in milligram per deciliter |
| Uric Acid(UA) | from baseline at 3 month | UA in milligram per deciliter |
| Hemoglobin(Hb) | from baseline at 3 month | Hb in gram per deciliter |
| Blood pressure | from baseline at 3 month | Blood pressure in millimeter of mercury |
| Waist circumference | from baseline at 3 month | Waist circumference in centimeter |
| Hip circumference | from baseline at 3 month | Hip circumference in centimeter |
| Upper arm circumference | from baseline at 3 month | Upper arm circumference in centimeter |
Countries
Taiwan
Outcome results
None listed