Lifestyle and pharmacological regulation of lipoprotein metabolism in the metabolic syndrome

Effect of weight loss and ezetimibe on high-density lipoprotein (HDL)-apolipoprotein (apo) A-I and HDL apoA-II transport in obese dyslipidaemic patients

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12606000152527

Enrollment

Registered

2006-05-02

Start date

2006-05-04

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The study hypothesis is that inhibition of cholesterol absorption complements the effects of weight loss on lipid and lipoprotein transport in obese subjects. Specifically , the study aims to elucidate the mechanisms of action of a new therapeutic regimen (weight loss plus ezetimibe) for regulating lipid and lipoprotein transport in these subjects.

Interventions

Weight loss plus Ezetimibe (12 week diet restricting weight reduction program followed with 4 week weight stabilizing period; ezetimibe, 10mg/day, is administrated in form of oral tablet for 16 weeks)

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

40 Years to 75 Years

Healthy volunteers

Inclusion criteria

BMI <40kg/m2 will be recruited. PM will be defined by: no menstrual cycle for 1 year and FSH >30U/L, or if the subject has had a hysterectomy or surgical sterilization. The MetS will be defined by the new International Diabetes Federation (IDF) criteria: central obesity (waist circumference >80cm for women and >94cm for men) plus triglycerides =1.7mmol/L, non-HDL-cholesterol >3.4mmol/L and insulin resistance (HOMA >2.2).Exclusion: Subjects with genetic hyperlipidemia, (eg FH), LDL-cholesterol >6.5mmol/L, proteinuria, hypothyroidism, alcoholism (>30g/day), creatinaemia (>130µmol/L), hepatic dysfunction (AST or ALT >3x ULN) and major systemic illness; pre-menopause women; use of steroids or other agents that may influence lipid metabolism, cardiovascular event within past 6 months, use of hypocaloric diets, anaemia; a history of intolerance to ezetimibe.

Exclusion criteria

No exclusion criteria

Outcome results