Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000721808
Ethics application status
Approved
Date submitted
4/07/2012
Date registered
5/07/2012
Date last updated
21/11/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
The Type 2 Diabetes PULSE study: a research trial to determine the effectiveness of a multi-component prevention program (diet, aerobic exercise, resistance training) for men at high risk of Type 2 Diabetes
Scientific title
The Type 2 Diabetes PULSE study: a randomised controlled trial to determine the feasibility and efficacy of a multi-component prevention program for men at high risk of Type 2 Diabetes
Secondary ID [1] 280593 0
Nil
Universal Trial Number (UTN)
U1111-1131-3596
Trial acronym
The Type 2 Diabetes PULSE study - Prevention Using LifeStyle Education
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pre-diabetes 286593 0
Type 2 Diabetes 286594 0
Obesity 286595 0
Metabolic syndrome 286596 0
Condition category
Condition code
Metabolic and Endocrine 286867 286867 0 0
Diabetes
Diet and Nutrition 286868 286868 0 0
Obesity
Cardiovascular 286869 286869 0 0
Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A 6-month randomised controlled trial of a novel Type 2 Diabetes prevention intervention: The Type 2 Diabetes PULSE study - Prevention Using Lifestyle Education.

The Type 2 Diabetes PULSE intervention will consist of a diet and exercise (aerobic and resistance training) program. Men in the intervention group will receive a resource pack with information regarding Type 2 Diabetes prevention.

The dietary intervention will consist of a resource manual with information/tips to improve diet quality and reduce Type 2 Diabetes risk such reducing overall energy intake, reading food labels, reducing portion size, reducing alcohol and sugared beverages, improving quality of diet (low GI carbohydrates, high fibre, low saturated fat), achieving an ideal macronutrient (carbohydrates-fat-protein) profile, reducing salt intake, and increasing fruit and vegetable intake. The participants will be asked to enter their dietary intake into a food and exercise diary (www.calorieking.com.au). The participants will not be prescribed a specific diet or meal plan.


The exercise intervention will consist of both aerobic and resistance training and will be self-administered over the duration of the 6-month intervention. Men will be asked to perform at least 150 mins/wk (5 x 30 min sessions) of moderate intensity aerobic exercise (e.g., walking, jogging, swimming, cycling) and at least 60 mins/wk (2 x 30 min sessions) of resistance training using body weight and Gymstick (an elastic tubing) exercises. The exercise resource manual will provide thorough instruction on how to safely perform the exercise. Participants will also receive an instruction video demonstrating the technique of the prescribed Gymstick and bodyweight exercises. These exercises will be conducted in their homes and will not be supervised. The participants will be also be asked to record the amount of exercise they do in an exercise log book and also into a food and exercise diary (www.calorieking.com.au)

Men will be assessed at baseline, 3- and 6-months on a range of health outcomes. Primary outcomes for the study are weight and fasting plasma glucose. Secondary outcomes will include anthropometric, plasma biomarker, and diet and exercise/fitness measures.

The wait-list control group will receive the intervention after the 6-month time-point and will be followed up for a further 6 months.
Intervention code [1] 284980 0
Prevention
Intervention code [2] 284981 0
Lifestyle
Intervention code [3] 284982 0
Behaviour
Comparator / control treatment
Wait-list control
Control group
Active

Outcomes
Primary outcome [1] 287222 0
Weight (kg)
Timepoint [1] 287222 0
Baseline, 3 and 6-months
Secondary outcome [1] 297660 0
Fasting Plasma Glucose (FPG) (mmol/L)
Timepoint [1] 297660 0
Baseline, 3 and 6-months
Secondary outcome [2] 297663 0
Body Mass Index (BMI) - kg/m2
Timepoint [2] 297663 0
Baseline, 3 and 6-months
Secondary outcome [3] 297664 0
Body composition (fat mass % and fat free mass %), using the Inbody 720 bioimpedance analyser.
Timepoint [3] 297664 0
Baseline, 3 and 6-months
Secondary outcome [4] 297665 0
Fasting insulin (mmol/L), obtained from a fasting blood sample
Timepoint [4] 297665 0
Baseline, 3 and 6-months
Secondary outcome [5] 297666 0
HOMA - Homeostatic Model Assessment for insulin resistance
Timepoint [5] 297666 0
Baseline, 3 and 6-months
Secondary outcome [6] 297667 0
QUICKI - Quantitative Insulin Sensitivity Check Index
Timepoint [6] 297667 0
Baseline, 3 and 6-months
Secondary outcome [7] 297668 0
Glycosylated haemoglobin (%) - obtained from a fasting blood sample
Timepoint [7] 297668 0
Baseline, 3 and 6-months
Secondary outcome [8] 297669 0
Fructosamine (mmol/L) - obtained from a fasting blood sample
Timepoint [8] 297669 0
Baseline, 3 and 6-months
Secondary outcome [9] 297670 0
Cholesterols - HDL, LDL and total (mmol/L) - obtained from a fasting blood sample
Timepoint [9] 297670 0
Baseline, 3 and 6-months
Secondary outcome [10] 297671 0
Triglycerides (mmol/L) - obtained from a fasting blood sample
Timepoint [10] 297671 0
Baseline, 3 and 6-months
Secondary outcome [11] 297672 0
C-reactive protein (nmol/L) - obtained from a fasting blood sample
Timepoint [11] 297672 0
Baseline, 3 and 6-months
Secondary outcome [12] 297673 0
Uric acid (mg/dl) - obtained from a fasting blood sample
Timepoint [12] 297673 0
Baseline, 3 and 6-months
Secondary outcome [13] 297674 0
Omega-3 index (%) - obtained from a fasting blood sample
Timepoint [13] 297674 0
Baseline, 3 and 6-months
Secondary outcome [14] 297676 0
Blood pressure (mmHg) using a standard sphygmomanometer with brachial cuff

Arterial stiffness markers (central pulse pressure, mmHg, and augmentation index, %) using the Sphygmocor CPV system
Timepoint [14] 297676 0
Baseline, 3 and 6-months
Secondary outcome [15] 297677 0
Dietary intake (Australian Eating Survey food frequency questionnaire)

Daily kJ intake
% macro-nutrients
Timepoint [15] 297677 0
Baseline, 3 and 6-months
Secondary outcome [16] 297678 0
Portion size questionnaire (DQES Victorian Cancer council)
Timepoint [16] 297678 0
Baseline, 3 and 6-months
Secondary outcome [17] 297679 0
Alcohol consumption questionnaire (AUDIT)
Timepoint [17] 297679 0
Baseline, 3 and 6-months
Secondary outcome [18] 297680 0
Aerobic fitness - sub-maximal treadmill test for VO2max prediction (mL/kg/min)
Timepoint [18] 297680 0
Baseline, 3 and 6-months
Secondary outcome [19] 297681 0
Muscular fitness (using barbell free weights)
Upper body strength - 5RM shoulder press (max kg)
Upper body endurance - 70% 1RM shoulder press (max repetitions)

Lower body endurance - body weight squat (max repetitions)
Timepoint [19] 297681 0
Baseline, 3 and 6-months
Secondary outcome [20] 297684 0
Physical Activity - pedometers (steps/day)
Timepoint [20] 297684 0
Baseline, 3 and 6-months
Secondary outcome [21] 298776 0
Waist circumference at two points using a non-distensible steel measuring tape.
1) Narrowest point between the lower costal border and the top of the iliac crest.
2) Level with the umbilicus
Timepoint [21] 298776 0
Baseline, 3 and 6-months

Eligibility
Key inclusion criteria
Inclusion criteria
- Aged 18-65 years
- Overweight or obese men with a body mass index (BMI) between 25 and 40 kg/m2
- An AUSDRISK score of >12 i.e., high risk
- Obtained a GP clearance if required confirming they are able to participate in a diet and exercise program
- Agree to not participate in other weight loss programs during the study
- Pass a health-screening questionnaire
- Available for assessment sessions
- Have access to a computer with e-mail and Internet facilities
Minimum age
18 Years
Maximum age
65 Years
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria
- Have T2D or a history of major medical problems such as heart disease
- Have orthopaedic or joint problems that would be a barrier to physical activity such as walking, running and resistance training
- Recently lost 5 kg or more in weight
- Are taking medications that might be affected by weight loss or affect weight loss or glucose tolerance/insulin sensitivity

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)
Participants will be required to pass an eligibility screening and health screening questionnaire. They may be required to obtain a doctors certificate for certain health circumstances. If eligible, they must read the study information statement, and sign and return a consent form indicating they understand the requirement of their participation in the study.

Participants will be randomised at an individual level by the trial statistician who will not have any contact with participants during the trial (see details below). Randomisation codes will stored in a restricted computer folder, which is not accessible by those assessing participants, those involved in group allocating participants or those participating in data entry for the study.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation into groups will be stratified by BMI category calculated at the baseline assessment (overweight, obese I, obese II) and age categories. The allocation sequence within strata will be generated by a computer-based random number-producing algorithm.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Wait-list control group will receive the intervention at the 6- months time-point. They will be followed up 6-months later (12 month time-point)
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/08/2012
Actual
24/08/2012
Date of last participant enrolment
Anticipated
Actual
7/03/2013
Date of last data collection
Anticipated
Actual
24/09/2013
Sample size
Target
150
Accrual to date
Final
101
Recruitment in Australia
Recruitment state(s)
ACT,NSW
Recruitment postcode(s) [1] 5346 0
2278
Recruitment postcode(s) [2] 5347 0
2282
Recruitment postcode(s) [3] 5348 0
2284
Recruitment postcode(s) [4] 5349 0
2285
Recruitment postcode(s) [5] 5350 0
2286
Recruitment postcode(s) [6] 5351 0
2287
Recruitment postcode(s) [7] 5352 0
2289
Recruitment postcode(s) [8] 5353 0
2290
Recruitment postcode(s) [9] 5354 0
2291
Recruitment postcode(s) [10] 5355 0
2292
Recruitment postcode(s) [11] 5356 0
2293
Recruitment postcode(s) [12] 5357 0
2294
Recruitment postcode(s) [13] 5358 0
2295
Recruitment postcode(s) [14] 5359 0
2296
Recruitment postcode(s) [15] 5360 0
2297
Recruitment postcode(s) [16] 5361 0
2298
Recruitment postcode(s) [17] 5362 0
2299
Recruitment postcode(s) [18] 5363 0
2300
Recruitment postcode(s) [19] 5364 0
2302
Recruitment postcode(s) [20] 5365 0
2303
Recruitment postcode(s) [21] 5366 0
2304
Recruitment postcode(s) [22] 5367 0
2305
Recruitment postcode(s) [23] 5368 0
2306
Recruitment postcode(s) [24] 5369 0
2307
Recruitment postcode(s) [25] 5370 0
2308
Recruitment postcode(s) [26] 5371 0
2309
Recruitment postcode(s) [27] 5372 0
2310
Recruitment postcode(s) [28] 5373 0
2311
Recruitment postcode(s) [29] 5374 0
2312
Recruitment postcode(s) [30] 5375 0
2314
Recruitment postcode(s) [31] 5376 0
2315
Recruitment postcode(s) [32] 5377 0
2316
Recruitment postcode(s) [33] 5378 0
2317
Recruitment postcode(s) [34] 5379 0
2318
Recruitment postcode(s) [35] 5380 0
2319
Recruitment postcode(s) [36] 5381 0
2320
Recruitment postcode(s) [37] 5382 0
2321
Recruitment postcode(s) [38] 5383 0
2322
Recruitment postcode(s) [39] 5384 0
2323
Recruitment postcode(s) [40] 14653 0
2324 - Balickera

Funding & Sponsors
Funding source category [1] 285351 0
Government body
Name [1] 285351 0
Hunter Medical Research Institute
Country [1] 285351 0
Australia
Funding source category [2] 285539 0
Other
Name [2] 285539 0
Queensland Rail (QR) National
Country [2] 285539 0
Australia
Primary sponsor type
Individual
Name
Professor Robin Callister
Address
Priority Research Centre for Physical Activity and Nutrition
The University of Newcastle
University Drive
Callaghan
NSW, 2308
Country
Australia
Secondary sponsor category [1] 284200 0
Individual
Name [1] 284200 0
Professor Philip Morgan
Address [1] 284200 0
Priority Research Centre for Physical Activity and Nutrition
The University of Newcastle
University Drive
Callaghan
NSW, 2308
Country [1] 284200 0
Australia
Other collaborator category [1] 276894 0
Individual
Name [1] 276894 0
Professor Clare Collins
Address [1] 276894 0
Priority Research Centre for Physical Activity and Nutrition
The University of Newcastle
University Drive
Callaghan
NSW, 2308
Country [1] 276894 0
Australia
Other collaborator category [2] 276895 0
Individual
Name [2] 276895 0
Professor Ronald Plotnikoff
Address [2] 276895 0
Priority Research Centre for Physical Activity and Nutrition
The University of Newcastle
University Drive
Callaghan
NSW, 2308
Country [2] 276895 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287371 0
The University of Newcastle Human Research Ethics Committee
Ethics committee address [1] 287371 0
Ethics committee country [1] 287371 0
Australia
Date submitted for ethics approval [1] 287371 0
26/06/2012
Approval date [1] 287371 0
09/08/2012
Ethics approval number [1] 287371 0
H-2012-0232

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34245 0
Prof Robin Callister
Address 34245 0
The University of Newcastle
Priority Research Centre for Physical Activity and Nutrition
University Drive
Callaghan, NSW, 2308
Country 34245 0
Australia
Phone 34245 0
+61 2 49215650
Fax 34245 0
Email 34245 0
[email protected]
Contact person for public queries
Name 17492 0
Elroy Aguiar
Address 17492 0
Level 3 Advanced Technology Centre (ATC)
Priority Research Centre for Physical Activity and Nutrition
School of Biomedical Sciences and Pharmacy
University of Newcastle
University Drive
Callaghan
NSW 2308
Country 17492 0
Australia
Phone 17492 0
+61 2 4985 4975
Fax 17492 0
+61 2 4921 2084
Email 17492 0
[email protected]
Contact person for scientific queries
Name 8420 0
Elroy Aguiar
Address 8420 0
Level 3 Advanced Technology Centre (ATC)
Priority Research Centre for Physical Activity and Nutrition
School of Biomedical Sciences and Pharmacy
University of Newcastle
University Drive
Callaghan
NSW 2308
Country 8420 0
Australia
Phone 8420 0
+61 2 4985 4975
Fax 8420 0
+61 2 4921 2084
Email 8420 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseThe PULSE (Prevention Using LifeStyle Education) trial protocol: A randomised controlled trial of a Type 2 Diabetes Prevention programme for men.2014https://dx.doi.org/10.1016/j.cct.2014.07.008
EmbaseCharacteristics of men classified at high-risk for type 2 diabetes mellitus using the AUSDRISK screening tool.2015https://dx.doi.org/10.1016/j.diabres.2015.01.017
EmbaseEfficacy of the Type 2 Diabetes Prevention Using LifeStyle Education Program RCT.2016https://dx.doi.org/10.1016/j.amepre.2015.08.020
EmbaseImpact on dietary intake of a self-directed, gender-tailored diabetes prevention program in men.2017https://dx.doi.org/10.4239/wjd.v8.i8.414
N.B. These documents automatically identified may not have been verified by the study sponsor.