Diamel in the Treatment of Metabolic Syndrome

Phase 3

Completed

• Conditions: Metabolic Syndrome
• Interventions: Dietary Supplement: Diamel; Dietary Supplement: Placebo

• Registration Number: NCT01025115
• Lead Sponsor: Catalysis SL

Brief Summary

The purpose of this study is to assess the efficacy of Diamel administration in the treatment of Metabolic Syndrome. The duration of this double-blind placebo controlled phase 3 clinical trial will be 12 months.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-03
• Study First Submitted: 2009-12-02
• Study First Submitted QC: 2009-12-02
• Study First Posted: 2009-12-03
• Status Verified: 2010-03
• Primary Completion: 2010-03
• Study Completion: 2010-03
• Last Update Submitted: 2010-03-30
• Last Update Posted: 2010-03-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Metabolic syndrome diagnosis according to WHO definition, with or without glucose intolerance.
• Signed informed consent

Exclusion Criteria

• Type 1 diabetes
• Type 2 diabetes treated with oral hypoglycemic drugs and/or insulin
• Other diseases associated with insulin resistance (eg. Acromegalia, endogenous hypercortisolism, etc)
• Neuropathies or hepatic conditions diagnosed biochemically or by clinical exam.
• Mild or severe heart conditions (eg. heart failure, ischemic cardiopathy)
• Sepsis or any other condition that could potentially interfere with treatment
• Any other treatment that could potentially interfere with treatment
• Pregnancy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A	Diamel	Diamel
B	Placebo	Placebo

Primary Outcome Measures

Name	Time	Method
Blood concentrations of HDL-cholesterol at months 0,3,6,9,12.	12 months
Blood concentrations of glucose at months 0,3,6,9,12.	12 months
Blood concentrations of insulin at months 0,3,6,9,12.	12 months
Blood concentrations of cholesterol at months 0,3,6,9,12.	12 months
Blood concentrations of triglycerides at months 0,3,6,9,12.	12 months
Blood concentrations of creatinine at months 0,3,6,9,12.	12 months
Blood concentrations of uric acid at months 0,3,6,9,12.	12 months

Secondary Outcome Measures

Name	Time	Method
Blood pressure at months 0,3,6,9,12.	12 months
BMI index at months 0,3,6,9,12.	12 months
Waist-to-hip index at months 0,3,6,9,12.	12 months

Trial Locations

Locations (1)

National Institute of Endocrinology; 🇨🇺 Havana City, Havana, Cuba