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

Phase 3

Completed

• Conditions: Metabolic Syndrome
• Interventions: Drug: Metamin 3D

• Registration Number: NCT01120873
• Lead Sponsor: Taichung Veterans General Hospital

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 Timeline

• Study Start: 2007-03
• Primary Completion: 2009-06
• Study Completion: 2009-06
• Status Verified: 2010-05
• Study First Submitted: 2010-05-05
• Study First Submitted QC: 2010-05-10
• Last Update Submitted: 2010-05-10
• Study First Posted: 2010-05-11
• Last Update Posted: 2010-05-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 110

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Metamin 3D	Metamin 3D	A randomized, double-blinded and placebo-controlled study

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Division of Endocrinology and Metabolism, Department of Internal Medicine, Taichung Veterans General Hospital; 🇨🇳 Taichang, Taiwan