The effect of Niacin on post-meal blood fat transport in men with type 2 diabetes

Phase 4

Completed

• Conditions: Type 2 diabetes; Metabolic and Endocrine - Diabetes

• Registration Number: ACTRN12609000448246
• Lead Sponsor: Professor Gerald Watts

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-06-12
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: Male
• Target Recruitment: 15

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified