ifestyle and pharmacological regulation of lipoprotein metabolism in the metabolic syndrome

• Conditions: Obesity; Type 2 diabetic mellitus; Dyslipidaemia; Diet and Nutrition - Obesity; Metabolic and Endocrine - Diabetes

• Registration Number: ACTRN12606000152527
• Lead Sponsor: niversity of Western Australia

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2006-05-02
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
High density lipoprotein (HDL)-apolipoprotein (apo) A-I and HDL-apoA-II production rates[Before and after 16 week intervention program];High density lipoprotein (HDL)-apolipoprotein (apo) A-I and HDL-apoA-II catabolic rates[Before and after 16 week intervention program]

Secondary Outcome Measures

Name	Time	Method
Apo B production and catabolic rates[Before and after 16 week intervention program.];Cholesterol absorption and synthesis[Before and after 16 week intervention program.]