Diabetes Mellitus, Type 2NCT03151837
Hypoglycemic Efficacy of Greenyn Momordica Charantia Extracts in Diabetic Subjects
A study testing Greenyn Momordica charantia extracts in people with Diabetes Mellitus, Type 2, run by Chung Shan Medical University at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Greenyn Momordica charantia extracts
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteTaiwan
- Study dates
- 10 May 2017to 16 Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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%)
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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).
Read the 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:
- 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.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Greenyn Momordica charantia extracts, Placebo control
- Keywords
- Diabetes, Bitter melon(Momordica charantia), Insulin sensitivity
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetes Mellitus, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Greenyn Momordica charantia extractsDietary supplement
Extracts from Momordica charantia containing Momordica charantia insulin receptor binding protein (mcIRBP)
Placebo controlDietary supplement
Starch
| Study group | Role | What they receive |
|---|---|---|
| Momordica charantia | Experimental | Subjects will take the capsule of Greenyn Momordica charantia extracts 600 mg/day orally for three months. Receives: Dietary Supplement: Greenyn Momordica charantia extracts |
| Placebo control | Placebo comparator | Subjects will take the capsule of Placebo 600 mg/day orally for three months. Receives: Dietary Supplement: Placebo control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fasting glucose
Fasting glucose in milligram per deciliter
Measured: from baseline at 3 month
Glycated hemoglobin
Glycated hemoglobin in percentage
Measured: from baseline at 3 month
Fasting insulin
Fasting insulin in milliunit per milliliter
Measured: from baseline at 3 month
Oral Glucose Tolerance Test
Oral Glucose Tolerance Test in milligram per deciliter
Measured: from baseline at 3 month
Secondary outcomes (17)
Total cholesterol
Total cholesterol in milligram per deciliter
Measured: from baseline at 3 month
L.D.L.cholesterol
L.D.L.cholesterol in milligram per deciliter
Measured: from baseline at 3 month
H.D.L.cholesterol
H.D.L.cholesterol in milligram per deciliter
Measured: from baseline at 3 month
Body mass index(BMI)
BMI in kg/m^2
Measured: from baseline at 3 month
Body fat
Body fat in percentage
Measured: from baseline at 3 month
Waist circumference
Waist circumference in centimeter
Measured: from baseline at 3 month
Hip circumference
Hip circumference in centimeter
Measured: from baseline at 3 month
Upper arm circumference
Upper arm circumference in centimeter
Measured: from baseline at 3 month
Ketone body
Ketone body in positive or negative
Measured: from baseline at 3 month
total protein
total protein in gram per deciliter
Measured: from baseline at 3 month
Blood pressure
Blood pressure in millimeter of mercury
Measured: from baseline at 3 month
Aspartate Aminotransferase (AST)
Aspartate Aminotransferase (AST) in IU per liter
Measured: from baseline at 3 month
Alanine Aminotransferase (ALT)
Alanine Aminotransferase (ALT) in IU per liter
Measured: from baseline at 3 month
Creatinine
Creatinine in milligram per deciliter
Measured: from baseline at 3 month
Blood urea nitrogen (BUN)
BUN in milligram per deciliter
Measured: from baseline at 3 month
Uric Acid(UA)
UA in milligram per deciliter
Measured: from baseline at 3 month
Hemoglobin(Hb)
Hb in gram per deciliter
Measured: from baseline at 3 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2017
- Study start10 May 2017
- Primary completion16 Dec 2017
- Study completion16 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chung Shan Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nae-Cherng Yang, Chung Shan Medical University
- Investigators
- Chien-Ning Huang, Ph.D., Principal investigator, Chung Shan Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03151837
- Sponsor's protocol ID
- CS16148
- Status last verified
- Jan 2018
- First submitted
- 26 Apr 2017
- Last updated
- 25 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled Trial to Evaluate the Hypoglycemic Efficacy of Greenyn Momordica Charantia Extracts in Diabetic Subjects
- ClinicalTrials.gov ID
- NCT03151837
- Acronym / sponsor ID
- CS16148
- Conditions
- Diabetes Mellitus, Type 2
- Keywords
- Diabetes, Bitter melon(Momordica charantia), Insulin sensitivity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Chung Shan Medical UniversityUniversity, hospital or other
- Study start
- 10 May 2017 (actual)
- Primary completion
- 16 Dec 2017 (actual)
- Study completion
- 16 Dec 2017 (actual)
- First posted
- 12 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Momordica charantia | Experimental | Dietary Supplement: Greenyn Momordica charantia extractsSubjects will take the capsule of Greenyn Momordica charantia extracts 600 mg/day orally for three months. |
| Placebo control | Placebo comparator | Dietary Supplement: Placebo controlSubjects will take the capsule of Placebo 600 mg/day orally for three months. |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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%)
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Greenyn Momordica charantia extractsExtracts from Momordica charantia containing Momordica charantia insulin receptor binding protein (mcIRBP) | Dietary supplement | Momordica charantia |
| Placebo controlStarch | Dietary supplement | Placebo control |
Primary outcome
Fasting glucose
Time frame: from baseline at 3 month
Fasting glucose in milligram per deciliter
Glycated hemoglobin
Time frame: from baseline at 3 month
Glycated hemoglobin in percentage
Fasting insulin
Time frame: from baseline at 3 month
Fasting insulin in milliunit per milliliter
Oral Glucose Tolerance Test
Time frame: from baseline at 3 month
Oral Glucose Tolerance Test in milligram per deciliter
17 secondary outcomes
Total cholesterol
Time frame: from baseline at 3 month
L.D.L.cholesterol
Time frame: from baseline at 3 month
H.D.L.cholesterol
Time frame: from baseline at 3 month
Body mass index(BMI)
Time frame: from baseline at 3 month
Body fat
Time frame: from baseline at 3 month
Waist circumference
Time frame: from baseline at 3 month
Hip circumference
Time frame: from baseline at 3 month
Upper arm circumference
Time frame: from baseline at 3 month
Ketone body
Time frame: from baseline at 3 month
total protein
Time frame: from baseline at 3 month
Blood pressure
Time frame: from baseline at 3 month
Aspartate Aminotransferase (AST)
Time frame: from baseline at 3 month
Alanine Aminotransferase (ALT)
Time frame: from baseline at 3 month
Creatinine
Time frame: from baseline at 3 month
Blood urea nitrogen (BUN)
Time frame: from baseline at 3 month
Uric Acid(UA)
Time frame: from baseline at 3 month
Hemoglobin(Hb)
Time frame: from baseline at 3 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chien-Ning Huang, Ph.D. principal investigator
Chung Shan Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Greenyn Momordica charantia extracts in people with Diabetes Mellitus, Type 2, run by Chung Shan Medical University at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fasting glucose (time frame: from baseline at 3 month). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jan 2018.