ACTRN12609000448246CompletedPhase 4
Reducing Cardiovascular Risk in Type 2 Diabetes: The effect of nicotinic acid prolonged release on postprandial lipoproetin metabolism in men with type 2 diabetes.
Professor Gerald Watts0 sites15 target enrollmentStarted: June 12, 2009Last updated:
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Enrollment
- 15
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
- Allocation
- Randomised controlled trial
- Primary Purpose
- Prevention
- Masking
- Open (masking not used)
Eligibility Criteria
- Ages
- 18 Years to 75 Years (—)
- Sex
- Male
Inclusion Criteria
- •Non-smoking men aged 18-75 years with a Body Mass Index (BMI) <40kg/m2 and type 2 diabetes will be recruited. Patients will be treated with 3-hydroxy-3-methylglutaryl coenzyme A (HMG-CoA) reductase inhibitor (statin) at a stable dose for greater than or equal to 6 weeks and will have attained a target low density lipoprotein (LDL)-cholesterol of <2.5mmol/L, fasting triglyceride <4.5mmol/L and/or high density lipoprotien (HDL)-cholesterol greater than or equal to 1.0mmol/L.
Exclusion Criteria
- •Subjects with genetic hyperlipidemia (e.g. familial hyperlipidaemia (FH), type III hyperlipidaemia), proteinuria, hypothyroidism, cholelithiasis, excess alcohol intake (>30g/day), haemoglobin A1c (HbA1c) >8.5%, daytime insulin treatment, uncontrolled hypertension >150/90mmHg; fasting cholesterol >6.0mmol/L or triglyceride >4.5mmol/L, creatinemia (>150umol/L), hepatic dysfunction ( aspartate ransaminase (AST) or alanine transaminase (ALT) >3x upper limit of normal (ULN), abnormal thyroid function, muscle disorders or creatinine kinase >3xULN; major systemic illness, use of steroids or other agents that may influence lipid metabolism, including fish oils, cardiovascular event within the last 6 months, anaemia or history of gout, or gastric disorders; patients on hypocaloric diets, lactose intolerance or intolerance to cream and eggs.
Investigators
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