The Effect of Metamin 3D on the Lipid and Glucose in Subjects With Metabolic Syndrome

This study has been completed.
Sponsor:
Information provided by:
Taichung Veterans General Hospital
ClinicalTrials.gov Identifier:
NCT01120873
First received: May 5, 2010
Last updated: May 10, 2010
Last verified: May 2010
  Purpose

To evaluate the effect of Metamin 3D on improvement of glucose and lipid on Taiwanese subjects with metabolic syndrome.


Condition Intervention Phase
Metabolic Syndrome
Drug: Metamin 3D
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Phase 3 Study of 3D in Metabolic Syndrome

Resource links provided by NLM:


Further study details as provided by Taichung Veterans General Hospital:

Primary Outcome Measures:
  • Total cholesterol [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    To assess the change of total cholesterol between 0 and 12 weeks


Secondary Outcome Measures:
  • Total cholesterol [ Time Frame: 4 and 8 weeks ] [ Designated as safety issue: No ]
    To assess the change of lipid profiles during study

  • Triglycerides [ Time Frame: 4 and 8 weeks ] [ Designated as safety issue: No ]
    To assess the change of lipid profiles during study

  • Low-density lipoprotein cholesterol [ Time Frame: 4, 8 and 12 weeks ] [ Designated as safety issue: No ]

    LDL cholesterol:

    To assess the lipid profiles during study


  • The plasma insulin by meal tolerant test [ Time Frame: 4 and 8 weeks ] [ Designated as safety issue: No ]
  • Glycosylated hemoglobin [ Time Frame: 4 and 8 weeks ] [ Designated as safety issue: No ]

    HbA1c:

    To assess the glycemic control during the study period


  • Fasting plasma glucose [ Time Frame: 4 and 8 weeks ] [ Designated as safety issue: Yes ]
    withdrawal if fasting glucose greater than 250 mg/dl

  • Systolic and diastolic blood pressure [ Time Frame: 4, 8 and 12 weeks ] [ Designated as safety issue: No ]
  • Triglycerides [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    To assess the change of lipid profiles between 0 and 12 weeks

  • The plasma glucose by meal tolerant test [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Glycosylated hemoglobin [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    To assess the change of HbA1c between 0 and 12 weeks

  • Fasting plasma glucose [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
    withdrawal if fasting glucose greater than 250 mg/dl

  • Aspartate aminotransferase [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]

    GOT:

    To assess the liver functions at 0 and 12 weeks


  • Alanine aminotransferase [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]

    GPT:

    To assess the liver functions at 0 and 12 weeks


  • Creatinine [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]

    Serum creatinine:

    To assess the renal function at 0 and 12 weeks



Enrollment: 110
Study Start Date: March 2007
Study Completion Date: June 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Metamin 3D
A randomized, double-blinded and placebo-controlled study
Drug: Metamin 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
Other Name: 3D

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.

  Eligibility

Ages Eligible for Study:   30 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age between 30 and 75 years
  • Fasting plasma glucose >= 100 mg/dl
  • Triglyceride >= 150 mg/dl
  • one of the criteria following

    1. HDL <40 mg/dl in man or <50 mg/dl in woman
    2. Blood pressure >= 135/85 mmHg or anti-hypertension drug treatment
    3. 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01120873

Locations
Taiwan
Division of Endocrinology and Metabolism, Department of Internal Medicine, Taichung Veterans General Hospital
Taichang, Taiwan, 407
Sponsors and Collaborators
Taichung Veterans General Hospital
Investigators
Principal Investigator: I Te Lee, MD Taichung Veterans General Hospital, Taichung
  More Information

Additional Information:
No publications provided

Responsible Party: I-Te, Lee, Division of Endocrinology and Metabolism, Department of Internal Medicine, Taichung Veterans General Hospital
ClinicalTrials.gov Identifier: NCT01120873     History of Changes
Other Study ID Numbers: S06203
Study First Received: May 5, 2010
Last Updated: May 10, 2010
Health Authority: Taiwan: Institutional Review Board

Keywords provided by Taichung Veterans General Hospital:
Hyperglycemia
dyslipidemia
Hypertension
Obesity

Additional relevant MeSH terms:
Metabolic Syndrome X
Syndrome
Disease
Glucose Metabolism Disorders
Hyperinsulinism
Insulin Resistance
Metabolic Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on October 23, 2014