Phase 2 N=40 Randomized Double-blind Prevention

Implications for Treatment of the Metabolic Syndrome

Metabolic Syndrome

Bottom Line

View on ClinicalTrials.gov: NCT00666029 ↗

Enrolled (actual)

Serious AEs

2.5%

Results posted

Jun 2016

Primary outcome: Primary: Muscle Microvascular Function — 3.7; 4.0 10^3 mL*min^-1*100ml^-1*mmHg^-1

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: atorvastatin (Drug); placebo (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: University Hospital Southampton NHS Foundation Trust
Primary completion: Feb 2008

Outcome Measures

Outcome	Result	p-value
PRIMARY Muscle Microvascular Function	3.7; 4.0	—
PRIMARY Insulin Sensitivity Index	0.56; 0.41	—

Summary

To characterize features of metabolic syndrome in volunteers. To undertake a randomised trial to determine whether treatment with a statin improves muscle microvascular blood flow.

Eligibility Criteria

Inclusion criteria Body mass index (BMI) 20-35 kg/m^2" and "> 3 criteria for the metabolic syndrome (NCEP III ATP criteria - see below) , one of which will be hypertriglyceridaemia, i.e. fasting plasma triglycerides >2.0 mmol/L - a cardinal lipid abnormality of the syndrome

NCEP III ATP metabolic syndrome criteria are:

Waist greater than or equal to 102 cm BP greater than 130 / 85 mmHg TG greater than or equal to 1.7mmol/l Glucose greater than or equal to 6.1 mmol/l HDL less than 1.0 mmol/l

Exclusion Criteria

Aged 75 years Known diabetes; renal, liver, or uncontrolled thyroid disease; uncontrolled hypertension; treatment with lipid-modifying drugs; antihypertensive medication; corticosteroid therapy; or hormone replacement therapy.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00666029). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.