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Trial registered on ANZCTR


Registration number
ACTRN12615000133538
Ethics application status
Approved
Date submitted
2/02/2015
Date registered
12/02/2015
Date last updated
16/02/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
The effects of alcohol consumption on cardiovascular risk in patients with type II diabetes mellitus
Scientific title
A controlled trial of the effect of alcohol on cardiovascular risk in type II diabetic patients
Secondary ID [1] 286087 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type II diabetes mellitus 294086 0
Blood pressure 294087 0
Serum lipids 294088 0
Condition category
Condition code
Cardiovascular 294395 294395 0 0
Hypertension
Diet and Nutrition 294396 294396 0 0
Other diet and nutrition disorders
Metabolic and Endocrine 294439 294439 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
During an initial 4-week run-in period, patients continue their usual regular alcohol intake and complete baseline assessment of their usual dietary and drinking patterns. They are then be randomized into a 3 period cross-over study of Latin square design, during which they consume during sequential 4-week study periods:-

(1) alcohol as red wine (a shiraz cabernet blend of known composition and alcohol content - alcohol 13% v/v, sourced from Orlando Wyndham, Rowland Flat, South Australia)
(a) in women: 20-30 g/day – approx. 140-210 g/week. (2-3 bottles/week with a minimum consumption of 20 g/day every day and maximum consumption of 30 g/day every day).
(b) in men: 30-40 g/day – approx. 210-280 g/week (3-4 bottles/week with a minimum consumption of 30 g/day every day and maximum consumption of 40 g/day every day).

or (2) an identical red wine but which has been de-alcoholised (again sourced from Orlando Wyndham, Rowland Flat, South Australia), consumed in equivalent volumes daily to the regular alcohol period. During this 4-week period they otherwise remain abstinent from all alcohol.

or (3) water. During this 4-week period they will otherwise remain abstinent from all alcohol.


The precise amount of red wine and de-alcoholised red wine within the above ranges is dictated by subject's usual alcohol intake at entry to the study.

There was no washout period between each 4-week study period.

All measurements are performed at the conclusion of the initial 4-week run-in period and at the conclusion of each 4-week study period. BP and heart rate are measured using 24-hour ambulatory BP measurements; glucose, insulin, lipids and lipoproteins are measured in fasting blood samples.

Compliance with the designated changes in alcohol intake are recorded by 7-day retrospective weekly diaries, completed at weekly visits to the clinical trials unit. In addition serum is sampled at the end of the 4-week run-in period and the end of each subsequent study period for both gamma-glutamyl transpeptidase and carbohydrate deficient transferrin as biomarkers of alcohol intake. Twenty-four hour urinary 4-O-methylgallic acid is determined as a biomarker of red wine intake.
Intervention code [1] 291080 0
Lifestyle
Comparator / control treatment
During a 4-week period subjects consume an equal volume of water with their meals but remain abstinent from all alcohol.
Control group
Active

Outcomes
Primary outcome [1] 294193 0
24 hr, daytime and night time ambulatory blood pressure.

24-hour ambulatory BP measurement is performed using a SpaceLabs Monitor (Model 90217, SpaceLabs Medical Inc) while subjects continue their normal routine. The recorder is preset to take BP and heart rate (HR) recordings every 30 min and is fitted at the conclusion of the initial 4-week run-in period and at the conclusion of each 4-week study period. BP records are not visible to the subjects. Subjects are instructed to complete an activity diary which describes the posture and activity of the subject at the time of the BP reading. While the BP measurements are being made, subjects are instructed to keep their arm motionless by their side to avoid artefactual readings caused by vibration. In cases when the SpaceLabs Monitor detects an error in BP measurement subjects are instructed to rectify the error or return to the department to have the recorder corrected. Readings associated with a test code and those with a difference of < 20 mmHg between SBP and DBP are excluded from analysis. Mean BP and HR are calculated for each of the 24 hours and then mean 24 hour, awake and asleep BP and HR are computed. Waking and sleeping times are determined from subjects’ activity diaries.
Timepoint [1] 294193 0
All measurements are performed at the conclusion of the initial 4-week run-in period and at the conclusion of each 4-week study period.
Secondary outcome [1] 312730 0
Fasting serum glucose and insulin levels
Timepoint [1] 312730 0
All measurements are performed at the conclusion of the initial 4-week run-in period and at the conclusion of each 4-week study period.
Secondary outcome [2] 312731 0
Serum lipids and lipoproteins
Timepoint [2] 312731 0
All measurements are performed at the conclusion of the initial 4-week run-in period and at the conclusion of each 4-week study period.
Secondary outcome [3] 320830 0
Plasma levels of specialized pro-resolving lipid mediators (SPM's) assessed by liquid chromatography–tandem mass spectrometry (LC-MS/MS).
Timepoint [3] 320830 0
All measurements are performed at the conclusion of the initial 4-week run-in period and at the conclusion of each 4-week study period.

Eligibility
Key inclusion criteria
Type II diabetic non-smoking men aged 40-70 years and postmenopausal women, recruited from the diabetic clinic at Royal Perth Hospital and by advertisement from the general population. Patients will have previous evidence of diabetes by either being on hypoglycaemic medication, or having had a diabetic glucose tolerance test, or at least 2 fasting plasma glucose concentrations > 7.1 mmol/l. They will be drinking an average of 2-3 standard drinks/day (20-30 g/day ethanol) for women or 3-4 standard drinks/day (30-40 g/day ethanol) for men. All patients will have HbA1c < 8.5%.
Minimum age
40 Years
Maximum age
70 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Type 1 diabetes
Recent (< 3 months) symptomatic heart disease
Angina pectoris
History of myocardial infarction or stroke
Peripheral vascular disease
Major surgery < 3 months
BP >170/100 mmHg
Liver or renal disease (plasma creatinine >120 mmol/L)
HbA1c > 8.5%
Smokers & ex-smokers < 2 years

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)
Concealment by central randomisation
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
The 24 hr ambulatory BP records are analysed utilising pooled time series regression with random effects models adjusted for serial correlation.Using data from our previous study of the effects of alcohol consumption on ambulatory BP in men, we estimate that with change in 24 hr ambulatory systolic BP as the major endpoint there will be at least 80% power to demonstrate a 5 mmHg change (SD of difference in paired values in SBP=7.5 mmHg). We estimate that with an adjusted alpha level of 0.015 (assuming the potential for 3 paired comparisons), that 27 subjects will be required.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 3393 0
Royal Perth Hospital - Perth
Recruitment postcode(s) [1] 9177 0
6000 - Perth

Funding & Sponsors
Funding source category [1] 290674 0
Charities/Societies/Foundations
Name [1] 290674 0
Australian Health Management Group
Address [1] 290674 0
23-27 Macquarie St (Cnr O'Donnell St)
PO Box 1436 Parramatta NSW 2124
Country [1] 290674 0
Australia
Primary sponsor type
University
Name
University of Western Australia
Address
The University of Western Australia
35 Stirling Hwy
Crawley WA 6009
Country
Australia
Secondary sponsor category [1] 289367 0
Individual
Name [1] 289367 0
Ian B Puddey
Address [1] 289367 0
School of Medicine and Pharmacology
Faculty of Medicine, Dentistry and Health Sciences
University of Western Australia
RPH MRF Building
Rear 50 Murray St, Perth, WA 6000
Country [1] 289367 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292304 0
Ethics Committee, Royal Perth Hospital
Ethics committee address [1] 292304 0
Ethics Committee
Royal Perth Hospital
Wellington St Campus
Box X2213
GPO Perth WA 6001
Ethics committee country [1] 292304 0
Australia
Date submitted for ethics approval [1] 292304 0
Approval date [1] 292304 0
07/08/2002
Ethics approval number [1] 292304 0
EC 2003/004

Summary
Brief summary
The current epidemiological literature suggests that regular higher consumption of alcohol raises blood pressure (BP). In view of the well-known association between BP and cardiovascular disease (CVD), and the fact that patients with diabetes have increased risk of CVD, this trial tests the hypothesis that a reduction in alcohol intake in Type II diabetic patients who are regular drinkers, will reduce cardiovascular risk.
Trial website
Trial related presentations / publications
Puddey IB, Mori TA, Burke V, Zilkens RR, Hodgson JM, Beilin LJ. The effects of alcohol on blood pressure, HDL-C and glycaemic control in Type 2 diabetic subjects: a controlled intervention study. J Hypertension 2005, 23 (Supplement 2):S99.
Public notes

Contacts
Principal investigator
Name 54566 0
Prof Ian B Puddey
Address 54566 0
School of Medicine and Pharmacology Faculty of Medicine, Dentistry and
Health Sciences University of Western Australia RPH MRF Building Rear 50
Murray St, Perth, WA 6000
Country 54566 0
Australia
Phone 54566 0
+61 8 92240232 or +61 8 92240258
Fax 54566 0
Email 54566 0
Ian.Puddey@uwa.edu.au
Contact person for public queries
Name 54567 0
Prof Ian B Puddey
Address 54567 0
School of Medicine and Pharmacology Faculty of Medicine, Dentistry and
Health Sciences University of Western Australia RPH MRF Building Rear 50
Murray St, Perth, WA 6000
Country 54567 0
Australia
Phone 54567 0
+61 8 92240232 or +61 8 92240258
Fax 54567 0
Email 54567 0
Ian.Puddey@uwa.edu.au
Contact person for scientific queries
Name 54568 0
Prof Ian B Puddey
Address 54568 0
School of Medicine and Pharmacology Faculty of Medicine, Dentistry and
Health Sciences University of Western Australia RPH MRF Building Rear 50
Murray St, Perth, WA 6000
Country 54568 0
Australia
Phone 54568 0
+61 8 92240232 or +61 8 92240258
Fax 54568 0
Email 54568 0
Ian.Puddey@uwa.edu.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary