ANZCTR - Registration

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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]

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

Type 2 Diabetes

Obesity

Metabolic syndrome

Condition category

Condition code

Metabolic and Endocrine

Diabetes

Diet and Nutrition

Obesity

Cardiovascular

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]

Prevention

Intervention code [2]

Lifestyle

Intervention code [3]

Behaviour

Comparator / control treatment

Wait-list control

Control group

Active

Outcomes

Primary outcome [1]

Weight (kg)

Timepoint [1]

Baseline, 3 and 6-months

Secondary outcome [1]

Fasting Plasma Glucose (FPG) (mmol/L)

Timepoint [1]

Baseline, 3 and 6-months

Secondary outcome [2]

Body Mass Index (BMI) - kg/m2

Timepoint [2]

Baseline, 3 and 6-months

Secondary outcome [3]

Body composition (fat mass % and fat free mass %), using the Inbody 720 bioimpedance analyser.

Timepoint [3]

Baseline, 3 and 6-months

Secondary outcome [4]

Fasting insulin (mmol/L), obtained from a fasting blood sample

Timepoint [4]

Baseline, 3 and 6-months

Secondary outcome [5]

HOMA - Homeostatic Model Assessment for insulin resistance

Timepoint [5]

Baseline, 3 and 6-months

Secondary outcome [6]

QUICKI - Quantitative Insulin Sensitivity Check Index

Timepoint [6]

Baseline, 3 and 6-months

Secondary outcome [7]

Glycosylated haemoglobin (%) - obtained from a fasting blood sample

Timepoint [7]

Baseline, 3 and 6-months

Secondary outcome [8]

Fructosamine (mmol/L) - obtained from a fasting blood sample

Timepoint [8]

Baseline, 3 and 6-months

Secondary outcome [9]

Cholesterols - HDL, LDL and total (mmol/L) - obtained from a fasting blood sample

Timepoint [9]

Baseline, 3 and 6-months

Secondary outcome [10]

Triglycerides (mmol/L) - obtained from a fasting blood sample

Timepoint [10]

Baseline, 3 and 6-months

Secondary outcome [11]

C-reactive protein (nmol/L) - obtained from a fasting blood sample

Timepoint [11]

Baseline, 3 and 6-months

Secondary outcome [12]

Uric acid (mg/dl) - obtained from a fasting blood sample

Timepoint [12]

Baseline, 3 and 6-months

Secondary outcome [13]

Omega-3 index (%) - obtained from a fasting blood sample

Timepoint [13]

Baseline, 3 and 6-months

Secondary outcome [14]

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]

Baseline, 3 and 6-months

Secondary outcome [15]

Dietary intake (Australian Eating Survey food frequency questionnaire)

Daily kJ intake
% macro-nutrients

Timepoint [15]

Baseline, 3 and 6-months

Secondary outcome [16]

Portion size questionnaire (DQES Victorian Cancer council)

Timepoint [16]

Baseline, 3 and 6-months

Secondary outcome [17]

Alcohol consumption questionnaire (AUDIT)

Timepoint [17]

Baseline, 3 and 6-months

Secondary outcome [18]

Aerobic fitness - sub-maximal treadmill test for VO2max prediction (mL/kg/min)

Timepoint [18]

Baseline, 3 and 6-months

Secondary outcome [19]

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]

Baseline, 3 and 6-months

Secondary outcome [20]

Physical Activity - pedometers (steps/day)

Timepoint [20]

Baseline, 3 and 6-months

Secondary outcome [21]

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]

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?

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]

2278

Recruitment postcode(s) [2]

2282

Recruitment postcode(s) [3]

2284

Recruitment postcode(s) [4]

2285

Recruitment postcode(s) [5]

2286

Recruitment postcode(s) [6]

2287

Recruitment postcode(s) [7]

2289

Recruitment postcode(s) [8]

2290

Recruitment postcode(s) [9]

2291

Recruitment postcode(s) [10]

2292

Recruitment postcode(s) [11]

2293

Recruitment postcode(s) [12]

2294

Recruitment postcode(s) [13]

2295

Recruitment postcode(s) [14]

2296

Recruitment postcode(s) [15]

2297

Recruitment postcode(s) [16]

2298

Recruitment postcode(s) [17]

2299

Recruitment postcode(s) [18]

2300

Recruitment postcode(s) [19]

2302

Recruitment postcode(s) [20]

2303

Recruitment postcode(s) [21]

2304

Recruitment postcode(s) [22]

2305

Recruitment postcode(s) [23]

2306

Recruitment postcode(s) [24]

2307

Recruitment postcode(s) [25]

2308

Recruitment postcode(s) [26]

2309

Recruitment postcode(s) [27]

2310

Recruitment postcode(s) [28]

2311

Recruitment postcode(s) [29]

2312

Recruitment postcode(s) [30]

2314

Recruitment postcode(s) [31]

2315

Recruitment postcode(s) [32]

2316

Recruitment postcode(s) [33]

2317

Recruitment postcode(s) [34]

2318

Recruitment postcode(s) [35]

2319

Recruitment postcode(s) [36]

2320

Recruitment postcode(s) [37]

2321

Recruitment postcode(s) [38]

2322

Recruitment postcode(s) [39]

2323

Recruitment postcode(s) [40]

2324 - Balickera

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

Hunter Medical Research Institute

Address [1]

Hunter Medical Research Institute
HMRI Clinical Research Centre
Level 3 John Hunter Hospital
Lookout Road
New Lambton Heights
NSW, 2305

Country [1]

Australia

Funding source category [2]

Other

Name [2]

Queensland Rail (QR) National

Address [2]

QR National
GPO Box 456
Brisbane, Qld, 4001

Country [2]

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]

Individual

Name [1]

Professor Philip Morgan

Address [1]

Priority Research Centre for Physical Activity and Nutrition
The University of Newcastle
University Drive
Callaghan
NSW, 2308

Country [1]

Australia

Other collaborator category [1]

Individual

Name [1]

Professor Clare Collins

Address [1]

Priority Research Centre for Physical Activity and Nutrition
The University of Newcastle
University Drive
Callaghan
NSW, 2308

Country [1]

Australia

Other collaborator category [2]

Individual

Name [2]

Professor Ronald Plotnikoff

Address [2]

Priority Research Centre for Physical Activity and Nutrition
The University of Newcastle
University Drive
Callaghan
NSW, 2308

Country [2]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

The University of Newcastle Human Research Ethics Committee

Ethics committee address [1]

The University of Newcastle
University Drive
Callaghan
NSW, 2308

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

26/06/2012

Approval date [1]

09/08/2012

Ethics approval number [1]

H-2012-0232

Summary

Brief summary

The Type 2 Diabetes PULSE (Prevention Using LifeStyle Education) study, is a 6 month research study evaluating the effectiveness of a men only Type 2 Diabetes prevention study that focuses on diet and home-based exercise (aerobic and resistance exercise).

Aims: To determine the feasibility and efficacy of a novel multi-component Type 2 Diabetes prevention program (diet + aerobic exercise + resistance exercise)

Hypotheses:
1. Compared to the wait-list control, the diet + aerobic training + RT intervention will result in a significant and a clinically meaningful reduction in weight as well as improvements in important secondary outcomes such as plasma biomarkers at 3 and 6 months post-baseline.

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 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.

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.

Trial website

N/A

Trial related presentations / publications

N/A

Public notes

Contacts

Principal investigator

Name

Prof Robin Callister

Address

The University of Newcastle
Priority Research Centre for Physical Activity and Nutrition
University Drive
Callaghan, NSW, 2308

Country

Australia

Phone

+61 2 49215650

Fax

[email protected]

Contact person for public queries

Name

Dr Elroy Aguiar

Address

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

Australia

Phone

+61 2 4985 4975

Fax

+61 2 4921 2084

[email protected]

Contact person for scientific queries

Name

Dr Elroy Aguiar

Address

Country

Australia

Phone

+61 2 4985 4975

Fax

+61 2 4921 2084

[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

Source	Title	Year of Publication	DOI
Embase	The PULSE (Prevention Using LifeStyle Education) trial protocol: A randomised controlled trial of a Type 2 Diabetes Prevention programme for men.	2014	https://dx.doi.org/10.1016/j.cct.2014.07.008
Embase	Impact on dietary intake of a self-directed, gender-tailored diabetes prevention program in men.	2017	https://dx.doi.org/10.4239/wjd.v8.i8.414
Embase	Efficacy of the Type 2 Diabetes Prevention Using LifeStyle Education Program RCT.	2016	https://dx.doi.org/10.1016/j.amepre.2015.08.020
Embase	Characteristics of men classified at high-risk for type 2 diabetes mellitus using the AUSDRISK screening tool.	2015	https://dx.doi.org/10.1016/j.diabres.2015.01.017

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

Documents added manually

Documents added automatically