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

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.

Study Overview

• Status: Completed
• Conditions: Metabolic Syndrome
• Intervention / Treatment: Drug: Metamin 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.

• Study Type: Interventional
• Enrollment (Actual): 110
• Phase: Phase 3

Contacts and Locations

Study Locations

• Taiwan
  • Taichang, Taiwan, 407
    • Division of Endocrinology and Metabolism, Department of Internal Medicine, Taichung Veterans General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: 3D

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total cholesterol	To assess the change of total cholesterol between 0 and 12 weeks	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total cholesterol	To assess the change of lipid profiles during study	4 and 8 weeks
Triglycerides	To assess the change of lipid profiles during study	4 and 8 weeks
Low-density lipoprotein cholesterol	LDL cholesterol: To assess the lipid profiles during study	4, 8 and 12 weeks
The plasma insulin by meal tolerant test		4 and 8 weeks
Glycosylated hemoglobin	HbA1c: To assess the glycemic control during the study period	4 and 8 weeks
Fasting plasma glucose	withdrawal if fasting glucose greater than 250 mg/dl	4 and 8 weeks
Systolic and diastolic blood pressure		4, 8 and 12 weeks
Triglycerides	To assess the change of lipid profiles between 0 and 12 weeks	12 weeks
The plasma glucose by meal tolerant test		12 weeks
Glycosylated hemoglobin	To assess the change of HbA1c between 0 and 12 weeks	12 weeks
Fasting plasma glucose	withdrawal if fasting glucose greater than 250 mg/dl	12 weeks
Aspartate aminotransferase	GOT: To assess the liver functions at 0 and 12 weeks	12 weeks
Alanine aminotransferase	GPT: To assess the liver functions at 0 and 12 weeks	12 weeks
Creatinine	Serum creatinine: To assess the renal function at 0 and 12 weeks	12 weeks

Collaborators and Investigators

• Sponsor: Taichung Veterans General Hospital
• Investigators: Principal Investigator: I Te Lee, MD, Taichung Veterans General Hospital, Taichung

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start: March 1, 2007
• Primary Completion (ACTUAL): June 1, 2009
• Study Completion (ACTUAL): June 1, 2009

Study Registration Dates

• First Submitted: May 5, 2010
• First Submitted That Met QC Criteria: May 10, 2010
• First Posted (ESTIMATE): May 11, 2010

Study Record Updates

• Last Update Posted (ESTIMATE): May 11, 2010
• Last Update Submitted That Met QC Criteria: May 10, 2010
• Last Verified: May 1, 2010

More Information

Terms related to this study

• Keywords: Obesity; Hypertension; Hyperglycemia; dyslipidemia
• Additional Relevant MeSH Terms: Pathologic Processes; Glucose Metabolism Disorders; Metabolic Diseases; Disease; Insulin Resistance; Hyperinsulinism; Syndrome; Metabolic Syndrome
• Other Study ID Numbers: S06203