Metabolic SyndromePhase 3NCT01120873
The Effect of Metamin 3D on the Lipid and Glucose in Subjects With Metabolic Syndrome
A Phase 3 study testing Metamin 3D in people with Metabolic Syndrome, run by Taichung Veterans General Hospital at 1 site in Taiwan.
Trial summary
To evaluate the effect of Metamin 3D on improvement of glucose and lipid on Taiwanese subjects with metabolic syndrome. Read more about this study
- Who is it for?
- Ages 30 to 75 years
- Conditions the study is for
- Metabolic Syndrome
- What is being tested?
- Metamin 3D
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteTaiwan
- Study dates
- Mar 2007to Jun 2009
- Phase
- Phase 3
- 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 30 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 30 and 75 years
- Fasting plasma glucose >= 100 mg/dl
- Triglyceride >= 150 mg/dl
- one of the criteria following
- HDL <40 mg/dl in man or <50 mg/dl in woman
- Blood pressure >= 135/85 mmHg or anti-hypertension drug treatment
- Waist >90cm in man or 80cm in woman
- Signed the inform consent
Who cannot join
- Fasting plasma glucose > 180mg/dl
- Treated by more than two types oral hypoglycemic agents in past 3 months
- Treated continuously by anti-lipid agents for 3 months in past 6 months
- Treated by thiazolidinedione or digitalis at present
- Serum creatine > 2.5mg/dl
- Liver function (GOT or GPT) more than 3-fold upper limit
Show all 9Show fewer
- Severe systemic disease by investigator's judgement
- Pregnant or nursing women
- Enrolled in other clinical study in recent 1 month
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
Division of Endocrinology and Metabolism, Department of Internal Medicine, Taichung Veterans General Hospital
Taichang, 407
About this study
Official title: Phase 3 Study of 3D in Metabolic Syndrome
To evaluate the effect of Metamin 3D on improvement of glucose and lipid on Taiwanese subjects with metabolic syndrome.
Read the detailed description
The Metamin 3D consists of mixed extractives of nature plants, including soy bean protein, bitter melon, red yeast rice, green algae and trisodium glycyrrhizinate. the improvement of lipid and glucose was reported respectively previously. We design a prospective, double-blinded and placebo-controlled study to evaluate the improvement on metabolic syndrome.
- Conditions
- Metabolic Syndrome
- Being tested
- Metamin 3D
- Keywords
- Hyperglycemia, dyslipidemia, Hypertension, Obesity
- Medical subject headings
- Metabolic Syndrome, Hyperglycemia, Dyslipidemias, Hypertension, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Metamin 3DDrug
Also called 3D
Metamin 3D is composed by red yeast rice, bitter gourd, chlorella, soy peptide and licorice extract is a commercial product designed by Uni-President enterprises corp in Taiwan
| Study group | Role | What they receive |
|---|---|---|
| Metamin 3D | Experimental | A randomized, double-blinded and placebo-controlled study Receives: Drug: Metamin 3D |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total cholesterol
To assess the change of total cholesterol between 0 and 12 weeks
Measured: 12 weeks
Secondary outcomes (14)
Total cholesterol
To assess the change of lipid profiles during study
Measured: 4 and 8 weeks
Triglycerides
To assess the change of lipid profiles during study
Measured: 4 and 8 weeks
Low-density lipoprotein cholesterol
LDL cholesterol:
To assess the lipid profiles during study
Measured: 4, 8 and 12 weeks
The plasma insulin by meal tolerant test
Measured: 4 and 8 weeks
Glycosylated hemoglobin
HbA1c:
To assess the glycemic control during the study period
Measured: 4 and 8 weeks
Fasting plasma glucose
withdrawal if fasting glucose greater than 250 mg/dl
Measured: 4 and 8 weeks
Systolic and diastolic blood pressure
Measured: 4, 8 and 12 weeks
Triglycerides
To assess the change of lipid profiles between 0 and 12 weeks
Measured: 12 weeks
The plasma glucose by meal tolerant test
Measured: 12 weeks
Glycosylated hemoglobin
To assess the change of HbA1c between 0 and 12 weeks
Measured: 12 weeks
Fasting plasma glucose
withdrawal if fasting glucose greater than 250 mg/dl
Measured: 12 weeks
Aspartate aminotransferase
GOT:
To assess the liver functions at 0 and 12 weeks
Measured: 12 weeks
Alanine aminotransferase
GPT:
To assess the liver functions at 0 and 12 weeks
Measured: 12 weeks
Creatinine
Serum creatinine:
To assess the renal function at 0 and 12 weeks
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2010 (estimated)
- Study startMar 2007
- Primary completionJun 2009
- Study completionJun 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic SyndromeStudies of the same condition, open and under way.
- More trials run by Taichung Veterans General HospitalThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taichung Veterans General Hospital
- Sponsor type
- University, hospital or other
- Investigators
- I Te Lee, MD, Principal investigator, Taichung Veterans General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01120873
- Sponsor's protocol ID
- S06203
- Status last verified
- May 2010
- First submitted
- 5 May 2010
- Last updated
- 11 May 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 3 Study of 3D in Metabolic Syndrome
- ClinicalTrials.gov ID
- NCT01120873
- Acronym / sponsor ID
- S06203
- Conditions
- Metabolic Syndrome
- Keywords
- Hyperglycemia, dyslipidemia, Hypertension, Obesity
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Taichung Veterans General HospitalUniversity, hospital or other
- Study start
- Mar 2007
- Primary completion
- Jun 2009 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 11 May 2010 (estimated)
- 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.
To evaluate the effect of Metamin 3D on improvement of glucose and lipid on Taiwanese subjects with metabolic syndrome.
Detailed description
The Metamin 3D consists of mixed extractives of nature plants, including soy bean protein, bitter melon, red yeast rice, green algae and trisodium glycyrrhizinate. the improvement of lipid and glucose was reported respectively previously. We design a prospective, double-blinded and placebo-controlled study to evaluate the improvement on metabolic syndrome.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Metamin 3D | Experimental | Drug: Metamin 3DA randomized, double-blinded and placebo-controlled study |
Who may qualify
- Ages
- 30 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age between 30 and 75 years
- Fasting plasma glucose >= 100 mg/dl
- Triglyceride >= 150 mg/dl
- one of the criteria following
- Signed the inform consent
Key exclusion criteria (9 listed)
- Fasting plasma glucose > 180mg/dl
- Treated by more than two types oral hypoglycemic agents in past 3 months
- Treated continuously by anti-lipid agents for 3 months in past 6 months
- Treated by thiazolidinedione or digitalis at present
- Serum creatine > 2.5mg/dl
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 |
|---|---|---|
| Metamin 3DAlso: 3DMetamin 3D is composed by red yeast rice, bitter gourd, chlorella, soy peptide and licorice extract is a commercial product designed by Uni-President enterprises corp in Taiwan | Drug | Metamin 3D |
Primary outcome
Total cholesterol
Time frame: 12 weeks
To assess the change of total cholesterol between 0 and 12 weeks
14 secondary outcomes
Total cholesterol
Time frame: 4 and 8 weeks
Triglycerides
Time frame: 4 and 8 weeks
Low-density lipoprotein cholesterol
Time frame: 4, 8 and 12 weeks
The plasma insulin by meal tolerant test
Time frame: 4 and 8 weeks
Glycosylated hemoglobin
Time frame: 4 and 8 weeks
Fasting plasma glucose
Time frame: 4 and 8 weeks
Systolic and diastolic blood pressure
Time frame: 4, 8 and 12 weeks
Triglycerides
Time frame: 12 weeks
The plasma glucose by meal tolerant test
Time frame: 12 weeks
Glycosylated hemoglobin
Time frame: 12 weeks
Fasting plasma glucose
Time frame: 12 weeks
Aspartate aminotransferase
Time frame: 12 weeks
Alanine aminotransferase
Time frame: 12 weeks
Creatinine
Time frame: 12 weeks
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 11 May 2010.
- Related InfoLink provided by the sponsor.
Related trials for Metabolic Syndrome
RecruitingObservational study
Defining the Natural History of Squamous Cell Carcinoma in Fanconi Anemia
Fanconi Anemia, Inherited Bone Marrow Failure Syndrome
Not yet recruitingPhase 2
Osilodrostat for Glycemic Control in Mild Autonomous Cortisol Secretion (MACS) With Difficult-To-Control Type 2 Diabetes - A Randomized, Double-Blind, Placebo-Controlled Phase 2 Study
Mild Autonomous Cortisol Secretion (MACS), Diabetes Mellitus (Type 2)
Active, not recruiting
Effects of Whole-body Electrical Muscle Stimulation Exercise on Adults With Neuromuscular Disease
Neuromuscular Diseases (NMD), Amyotrophic Lateral Sclerosis
Not yet recruitingObservational study
Clinical Genetics Branch Eligibility Screening Survey
Melanoma, Li-Fraumeni Syndrome
Not yet recruitingPhase 2
Effects of Meal Macronutrients on Postprandial Lipids
Nephrotic Syndrome, Lipodystrophy
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.
I Te Lee, MD principal investigator
Taichung Veterans General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Metamin 3D in people with Metabolic Syndrome, run by Taichung Veterans General Hospital 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 8 inclusion and 9 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 11 May 2010. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Total cholesterol (time frame: 12 weeks). 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 11 May 2010.