Randomised, double-blind, placebo controlled phase II study of the efficacy of Phospha-E biomarkers of inflammation, in patients with metabolic syndrome and mild to moderate hyperlipidemia.

Phase 2

• Conditions: Metabolic Syndrome; Metabolic and Endocrine - Other metabolic and endocrine disorders

• Registration Number: ACTRN12607000343404
• Lead Sponsor: Phosphagenics Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2007-06-26
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 160

Inclusion Criteria

Caucasians with a waist circumference of >102cm (40 inches) for men and >89cm (35 inches) for women.- plus 2 of the following: - type 2 diabetes (but not on medication) - fasting blood glucose between 6.1-7.0mmol/L. - impaired glucose tolerance, as determined in the preceeding months by a glucose tolerance test. - systolic blood pressure >135mmHg or diastolic blood pressure of >90mmHg. - fasted total cholesterol >5.2mmol/L - fasted triglycerides >1.7mmol/L - fasted LDL >3.4mmol/L - fasted HDL <1.036mmol/L for men and <1.295mmol/L for women. - hsCRP levels >3.0mg/

Exclusion Criteria

Subjects with significant impairment in renal and/or hepatic function as determined through pre-history-driven physical.- Subject has a creatine clearance of <60ml/min determined by Cockcroft-Gault's method.- Subject has had any gastric/bowel surgery.- Subject has known history of allergic responses to vitamin E.- Subject has taken hyperlipidemic, diabetic or hypertensive medication within the last 2 months.- Subject is pregnant or breast-feeding.- Subject has a high white blood cell count (WBC; greater than 15/high power field (hpf).

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To assess the effects of 2 doses of Phospha-E (200, 400IU) compared to placebo control and 1 dose of classical vitamin E (200IU) compared to placebo control, on biomarkers of inflammation by measuring changes in high sensitivity C-reactive protein (hsCRP) from baseline to 6 and 12 weeks post-randomisation.[Measurements will only be taken at baseline, 6 weeks and 12 weeks post-randomisation.]

Secondary Outcome Measures

Name	Time	Method
To assess the effects of 2 doses of Phospha-E (200 and 400IU) compared to placebo control and 1 dose of classical vitamin E (200IU) compared to placebo control, on the lipid profile by measuring absolute and percentage change in total cholesterol, triglycerides, low density lipoprotein (LDL) and high density lipoprotein (HDL) from baseline to weeks 6 and 12 post-randomisation.[Measurements will only be taken at baseline, 6 weeks and 12 weeks post-randomisation.]