NCT01120873CompletedPhase 3
Phase 3 Study of 3D in Metabolic Syndrome
Taichung Veterans General Hospital1 site in 1 country110 target enrollmentStarted: March 2007Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Enrollment
- 110
- Locations
- 1
- Primary Endpoint
- Total cholesterol
Study Overview
Brief Summary
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
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Investigator)
Eligibility Criteria
- Ages
- 30 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Arms & Interventions
Metamin 3D
Experimental
A randomized, double-blinded and placebo-controlled study
Intervention: Metamin 3D (Drug)
Outcomes
Primary Outcomes
Total cholesterol
Time Frame: 12 weeks
To assess the change of total cholesterol between 0 and 12 weeks
Secondary Outcomes
- Total cholesterol(4 and 8 weeks)
- Triglycerides(12 weeks)
- Low-density lipoprotein cholesterol(4, 8 and 12 weeks)
- The plasma insulin by meal tolerant test(4 and 8 weeks)
- Glycosylated hemoglobin(12 weeks)
- Fasting plasma glucose(12 weeks)
- Systolic and diastolic blood pressure(4, 8 and 12 weeks)
- The plasma glucose by meal tolerant test(12 weeks)
- Aspartate aminotransferase(12 weeks)
- Alanine aminotransferase(12 weeks)
- Creatinine(12 weeks)
Investigators
Study Sites (1)
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