Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000448246
Ethics application status
Approved
Date submitted
2/06/2009
Date registered
12/06/2009
Date last updated
1/07/2011
Type of registration
Prospectively registered

Titles & IDs
Public title
The effect of Niacin on post-meal blood fat transport in men with type 2 diabetes
Scientific title
Reducing Cardiovascular Risk in Type 2 Diabetes: The effect of nicotinic acid prolonged release on postprandial lipoproetin metabolism in men with type 2 diabetes.
Secondary ID [1] 889 0
Nil
Universal Trial Number (UTN)
Trial acronym
DIME
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 2 diabetes 236904 0
Condition category
Condition code
Metabolic and Endocrine 237258 237258 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Nicotinic acid prolonged release (PR), starting dose of 1000mg orally daily (od), increasing to 2000mg od after 4 weeks and maintaining this dose for the next 8 weeks (i.e. 12 week treatment period in total). This is a cross over study, therefore Nicotinic acid PR will be taken for 1 of the two 12 week treatment periods. There will be a 3 week washout period inbetween the 2 treatment periods. The second treatment period is a no treatment period. Nicotinic acid will be administered as an oral tablet.
Rosuvastatin, 5-40mg. All participants will be on stable dose concomittant Rosuvastatin for 6 weeks prior to the study and for the duration of the study. Rosuvastatin will be administered as an oral tablet at an optimal dose to acheive an low density lipoprotein-cholesterol of less than 2.5mmol/L.
Immediately following a high fat test meal, intravenous D3-leucine stable isotope and two oral vitamin A capsules (50,000U each) will be used as kinetic tracers of lipoprotien metabolism. These will be given twice, that is once only on each stable isotope day at the end of each (two) treatment periods.
Intervention code [1] 236693 0
Treatment: Drugs
Comparator / control treatment
no treatment
Control group
Active

Outcomes
Primary outcome [1] 238071 0
Apolipoprotein (apo) B48 Fractional Catabolic Rate (FCR) will be used as an assessment tool for the proportion of the apoB48 pool that is catabolized per day. Apo B48 FCR will be determined and compared between groups. All analyses will be carried out using SAS 9.1 (Cary, NC, USA). Group characteristics will be compared by t-tests and general linear modelling after logarithmmic transformation of skewed variables where appropriate. Treatment effects will be examined using SAS mixed-effect models and adjusted for baseline values. Carry-over effects will be examined. Associations will be examined by simple and multivariate linear regression method. Compartmental analysis will be used to develop and fit models to lipid and lipoprotein tracer data.
Timepoint [1] 238071 0
ApoB48 FCR time points are baseline, 5, 10, 20, 30, 40, 60mins, 1, 1.5, 2.0, 2.5, 3.0, 4.0, 5.0, 6.0, 8.0, 10.0, 24, 48, 72, 96 hours following administration of D3-leucine stable isotope and vitamin A capsules on 2 occasions i.e. once at the end of each (two) treatment periods.
Secondary outcome [1] 242263 0
Very low density lipoprotein (VLDL) apoB FCR will be used as an assessment tool for the proportion of the VLDL apoB pool that is catabolized per day. VLDL apoB FCR will be determined and compared between groups. All analyses will be carried out using SAS 9.1 (Cary, NC, USA). Group characteristics will be compared by t-tests and general linear modelling after logarithmmic transformation of skewed variables where appropriate. Treatment effects will be examined using SAS mixed-effect models and adjusted for baseline values. Carry-over effects will be examined. Associations will be examined by simple and multivariate linear regression method. Compartmental analysis will be used to develop and fit models to lipid and lipoprotein tracer data.
Timepoint [1] 242263 0
VLDL ApoB FCR time points are baseline, 5, 10, 20, 30, 40, 60mins, 1, 1.5, 2.0, 2.5, 3.0, 4.0, 5.0, 6.0, 8.0, 10.0, 24, 48, 72, 96 hours following administration of D3-leucine stable isotope and vitamin A capsules on 2 occasions i.e. once at the end of each (two) treatment periods.
Secondary outcome [2] 242264 0
High density lipoprotien (HDL) ApoAI produciton rate will be used as an assessment tool for the rate of production of HDL ApoA1. HDL ApoAI production rate will be determined and compared between groups. All analyses will be carried out using SAS 9.1 (Cary, NC, USA). Group characteristics will be compared by t-tests and general linear modelling after logarithmmic transformation of skewed variables where appropriate. Treatment effects will be examined using SAS mixed-effect models and adjusted for baseline values. Carry-over effects will be examined. Associations will be examined by simple and multivariate linear regression method. Compartmental analysis will be used to develop and fit models to lipid and lipoprotein tracer data.
Timepoint [2] 242264 0
HDL apoAI production rate time points are baseline, 5, 10, 20, 30, 40, 60mins, 1, 1.5, 2.0, 2.5, 3.0, 4.0, 5.0, 6.0, 8.0, 10.0, 24, 48, 72, 96 hours following administration of D3-leucine stable isotope and vitamin A capsules on 2 occasions i.e. once at the end of each (two) treatment periods.

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
75 Years
Sex
Males
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation involves contactin the person holding the allocation schedule and who is not involved in the study
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomised sequence generated by computer
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Phase 4
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
15/06/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
15
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 237083 0
Government body
Name [1] 237083 0
National Health and Medical Research Council (NHMRC) grant, University of Western Australia
Country [1] 237083 0
Australia
Primary sponsor type
Individual
Name
Professor Gerald Watts
Address
School of Medicine and Pharmacology, Royal Perth Hospital, Rear 50 Murray Street, PO Box X2213, Perth, WA 6847.
Country
Australia
Secondary sponsor category [1] 4588 0
None
Name [1] 4588 0
Address [1] 4588 0
Country [1] 4588 0
Other collaborator category [1] 702 0
Individual
Name [1] 702 0
Professor Hugh Barrett
Address [1] 702 0
School of Medicine and Pharmacology, Royal Perth Hospital, Rear 50 Murray Street, PO Box X2213, Perth, WA 6847.
Country [1] 702 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 239184 0
Royal Perth Hospital Ethics Committee
Ethics committee address [1] 239184 0
Royal Perth Hospital, Wellington Street, PO Box X2213, Perth, WA 6847.
Ethics committee country [1] 239184 0
Australia
Date submitted for ethics approval [1] 239184 0
03/03/2009
Approval date [1] 239184 0
05/05/2009
Ethics approval number [1] 239184 0
EC 2009/018

Summary
Brief summary
The aim is to carry out a cross-over study to determine if Nicotinic acid prolonged release (Nicotinic acid PR) has beneficial effects on postprandial lipid and lipoprotein concentrations and apoprotein transport rates in patients with type 2 diabetes (T2DM) who are at high risk of cardiovascular disease (CVD). In these participants, Nicotinic acid PR will be used in combination with their current optimal dose statin therapy.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29684 0
Address 29684 0
Country 29684 0
Phone 29684 0
Fax 29684 0
Email 29684 0
Contact person for public queries
Name 12931 0
Sandra Hamilton
Address 12931 0
School of Medicine and Pharmacology, Royal Perth Hospital, Rear 50 Murray Street, PO Box X2213, Perth, WA 6847
Country 12931 0
Australia
Phone 12931 0
+61 8 9224 0318
Fax 12931 0
+61 8 9224 0243
Email 12931 0
sandy.hamilton@uwa.edu.au
Contact person for scientific queries
Name 3859 0
Professor Hugh Barrett
Address 3859 0
School of Medicine and Pharmacology, Royal Perth Hospital, Rear 50 Murray Street, PO Box X2213, Perth, WA 6847
Country 3859 0
Australia
Phone 3859 0
+61 8 9224 0249
Fax 3859 0
+61 8 9224 0246
Email 3859 0
hugh.barrett@uwa.edu.au

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No Supporting Document Provided



Results publications and other study-related documents

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