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

Primary Purpose

Metabolic Syndrome

Status
Completed
Phase
Phase 3
Locations
Taiwan
Study Type
Interventional
Intervention
Metamin 3D
Sponsored by
Taichung Veterans General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Metabolic Syndrome focused on measuring Hyperglycemia, dyslipidemia, Hypertension, Obesity

Eligibility Criteria

30 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Division of Endocrinology and Metabolism, Department of Internal Medicine, Taichung Veterans General Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Metamin 3D

Arm Description

A randomized, double-blinded and placebo-controlled study

Outcomes

Primary Outcome Measures

Total cholesterol
To assess the change of total cholesterol between 0 and 12 weeks

Secondary Outcome Measures

Total cholesterol
To assess the change of lipid profiles during study
Triglycerides
To assess the change of lipid profiles during study
Low-density lipoprotein cholesterol
LDL cholesterol: To assess the lipid profiles during study
The plasma insulin by meal tolerant test
Glycosylated hemoglobin
HbA1c: To assess the glycemic control during the study period
Fasting plasma glucose
withdrawal if fasting glucose greater than 250 mg/dl
Systolic and diastolic blood pressure
Triglycerides
To assess the change of lipid profiles between 0 and 12 weeks
The plasma glucose by meal tolerant test
Glycosylated hemoglobin
To assess the change of HbA1c between 0 and 12 weeks
Fasting plasma glucose
withdrawal if fasting glucose greater than 250 mg/dl
Aspartate aminotransferase
GOT: To assess the liver functions at 0 and 12 weeks
Alanine aminotransferase
GPT: To assess the liver functions at 0 and 12 weeks
Creatinine
Serum creatinine: To assess the renal function at 0 and 12 weeks

Full Information

First Posted
May 5, 2010
Last Updated
May 10, 2010
Sponsor
Taichung Veterans General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01120873
Brief Title
The Effect of Metamin 3D on the Lipid and Glucose in Subjects With Metabolic Syndrome
Official Title
Phase 3 Study of 3D in Metabolic Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
May 2010
Overall Recruitment Status
Completed
Study Start Date
March 2007 (undefined)
Primary Completion Date
June 2009 (Actual)
Study Completion Date
June 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Taichung Veterans General Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metabolic Syndrome
Keywords
Hyperglycemia, dyslipidemia, Hypertension, Obesity

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
110 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Metamin 3D
Arm Type
Experimental
Arm Description
A randomized, double-blinded and placebo-controlled study
Intervention Type
Drug
Intervention Name(s)
Metamin 3D
Other Intervention Name(s)
3D
Intervention Description
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
Primary Outcome Measure Information:
Title
Total cholesterol
Description
To assess the change of total cholesterol between 0 and 12 weeks
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Total cholesterol
Description
To assess the change of lipid profiles during study
Time Frame
4 and 8 weeks
Title
Triglycerides
Description
To assess the change of lipid profiles during study
Time Frame
4 and 8 weeks
Title
Low-density lipoprotein cholesterol
Description
LDL cholesterol: To assess the lipid profiles during study
Time Frame
4, 8 and 12 weeks
Title
The plasma insulin by meal tolerant test
Time Frame
4 and 8 weeks
Title
Glycosylated hemoglobin
Description
HbA1c: To assess the glycemic control during the study period
Time Frame
4 and 8 weeks
Title
Fasting plasma glucose
Description
withdrawal if fasting glucose greater than 250 mg/dl
Time Frame
4 and 8 weeks
Title
Systolic and diastolic blood pressure
Time Frame
4, 8 and 12 weeks
Title
Triglycerides
Description
To assess the change of lipid profiles between 0 and 12 weeks
Time Frame
12 weeks
Title
The plasma glucose by meal tolerant test
Time Frame
12 weeks
Title
Glycosylated hemoglobin
Description
To assess the change of HbA1c between 0 and 12 weeks
Time Frame
12 weeks
Title
Fasting plasma glucose
Description
withdrawal if fasting glucose greater than 250 mg/dl
Time Frame
12 weeks
Title
Aspartate aminotransferase
Description
GOT: To assess the liver functions at 0 and 12 weeks
Time Frame
12 weeks
Title
Alanine aminotransferase
Description
GPT: To assess the liver functions at 0 and 12 weeks
Time Frame
12 weeks
Title
Creatinine
Description
Serum creatinine: To assess the renal function at 0 and 12 weeks
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
I Te Lee, MD
Organizational Affiliation
Taichung Veterans General Hospital, Taichung
Official's Role
Principal Investigator
Facility Information:
Facility Name
Division of Endocrinology and Metabolism, Department of Internal Medicine, Taichung Veterans General Hospital
City
Taichang
ZIP/Postal Code
407
Country
Taiwan

12. IPD Sharing Statement

Links:
URL
http://www.ncbi.nlm.nih.gov/entrez/query/static/citmatch.html
Description
Related Info

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

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