Clinical trial NCT01120873: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Metabolic Syndrome
Keywords: Hyperglycemia
dyslipidemia
Hypertension
Obesity
Lead sponsor: Taichung Veterans General Hospital
Sponsor class: OTHER
First posted: 2010-05-11
Enrollment: 110
Sex: ALL
Minimum age (years): 30
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

  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

Primary outcomes:
measure: Total cholesterol
timeFrame: 12 weeks
Secondary outcomes:
measure: Total cholesterol
timeFrame: 4 and 8 weeks
measure: Triglycerides
timeFrame: 4 and 8 weeks
measure: Low-density lipoprotein cholesterol
timeFrame: 4, 8 and 12 weeks
measure: The plasma insulin by meal tolerant test
timeFrame: 4 and 8 weeks
measure: Glycosylated hemoglobin
timeFrame: 4 and 8 weeks
measure: Fasting plasma glucose
timeFrame: 4 and 8 weeks
measure: Systolic and diastolic blood pressure
timeFrame: 4, 8 and 12 weeks
measure: Triglycerides
timeFrame: 12 weeks
measure: The plasma glucose by meal tolerant test
timeFrame: 12 weeks
measure: Glycosylated hemoglobin
timeFrame: 12 weeks
measure: Fasting plasma glucose
timeFrame: 12 weeks
measure: Aspartate aminotransferase
timeFrame: 12 weeks
measure: Alanine aminotransferase
timeFrame: 12 weeks
measure: Creatinine
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Taichang
country: Taiwan
facility: Division of Endocrinology and Metabolism, Department of Internal Medicine, Taichung Veterans General Hospital
Study officials:
affiliation: Taichung Veterans General Hospital, Taichung
name: I Te Lee, MD
role: PRINCIPAL_INVESTIGATOR
References: