The Effect of Metamin 3D on the Lipid and Glucose in Subjects With Metabolic Syndrome
Phase 3 Study of 3D in Metabolic Syndrome
1 other identifier
interventional
110
1 country
1
Brief Summary
To evaluate the effect of Metamin 3D on improvement of glucose and lipid on Taiwanese subjects with metabolic syndrome.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Mar 2007
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2009
CompletedFirst Submitted
Initial submission to the registry
May 5, 2010
CompletedFirst Posted
Study publicly available on registry
May 11, 2010
CompletedMay 11, 2010
May 1, 2010
2.3 years
May 5, 2010
May 10, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Total cholesterol
To assess the change of total cholesterol between 0 and 12 weeks
12 weeks
Secondary Outcomes (14)
Total cholesterol
4 and 8 weeks
Triglycerides
4 and 8 weeks
Low-density lipoprotein cholesterol
4, 8 and 12 weeks
The plasma insulin by meal tolerant test
4 and 8 weeks
Glycosylated hemoglobin
4 and 8 weeks
- +9 more secondary outcomes
Study Arms (1)
Metamin 3D
EXPERIMENTALA randomized, double-blinded and placebo-controlled study
Interventions
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
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- Severe systemic disease by investigator's judgement
- Pregnant or nursing women
- Enrolled in other clinical study in recent 1 month
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Division of Endocrinology and Metabolism, Department of Internal Medicine, Taichung Veterans General Hospital
Taichang, 407, Taiwan
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
I Te Lee, MD
Taichung Veterans General Hospital, Taichung
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
May 5, 2010
First Posted
May 11, 2010
Study Start
March 1, 2007
Primary Completion
June 1, 2009
Study Completion
June 1, 2009
Last Updated
May 11, 2010
Record last verified: 2010-05