Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617000146392
Ethics application status
Approved
Date submitted
23/01/2017
Date registered
27/01/2017
Date last updated
9/05/2019
Date data sharing statement initially provided
9/05/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Preventing the Progression from Pre-Diabetes to Type 2 diabetes in New Zealanders Through Weight Loss: The PROGRESS NZ Study
Scientific title
The impact of a very low calorie diet on glucose metabolism, energy expenditure and body composition in individuals with pre-diabetes or early Type 2 diabetes in New Zealand: The PROGRESS NZ Study
Secondary ID [1] 290987 0
None
Universal Trial Number (UTN)
U1111-1186-7316
Trial acronym
The PROGRESS NZ Study
Linked study record
N/A

Health condition
Health condition(s) or problem(s) studied:
Diabetes
 301742 0
Pre-Diabetes 301743 0
Obesity 301744 0
Condition category
Condition code
Metabolic and Endocrine 301440 301440 0 0
Diabetes
Diet and Nutrition 301464 301464 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The PROGRESS NZ Study is a prospective cohort study in individuals with pre-diabetes and early Type 2 diabetes, that has been designed to assess the relationship between body composition and glucose metabolism at baseline and in response to a dietary weight loss intervention. All individuals in the study will proceed to a weight loss intervention. Glucose metabolism at baseline and post the weight loss will be analysed using a hyperinsulinaemic euglycaemic clamp with stable isotope dilution and an arginine insulin secretion test. Body composition will be assessed using DXA scanning, whilst energy expenditure shall be calculated using hood calorimetry. Statistical analysis shall be with ANCOVA with assessment of the weight loss intervention; body composition (continuous variable) and their interaction.

The weight loss intervention will involve undergoing an 'Optifast' very low calorie diet (VLCD) until 10% body weight is lost. This would be anticipated to take approximately 12 weeks to achieve if compliance is met. There is no maximum duration of diet determined. Optifast is a meal replacement supplement in the form of a shake. Individuals will be required to drink three Optifast shakes (meal replacements) per day as well as two cups of non-starchy vegetables and water. Each day of three shakes would provide 600calories per day, with 58g of protein and 39-71g of carbohydrate. An information sheet prepared by an Endocrinologist and dietician with experience in clinical research will be provided which shall detail the quantity of vegetables and type of vegetables permitted, as well as serving suggestions.
Individuals will be contacted via telephone weekly to monitor progress and will visit the clinical facility (The University of Otago, Wellington Campus) monthly for a check-up including weight and blood pressure monitoring.
Intervention adherence will be assessed using a combination of participant self-reported compliance and urinary ketone testing during the visits.

In addition to the above interventional study, participants will then be invited to complete a six week exercise intervention, to assess the feasibility of the exercise protocol for larger research trials. This is not a compulsory component of the PROGRESS NZ study. This addition has full ethics approval.

For those participants willing to take part, individuals will complete a six week exercise intervention one month after completing the Optifast diet. The intervention follows American College of Sports Medicine guidelines and will be fully supervised by an investigator trained in sports exercise and injury prevention. Participants will undergo a full cardiovascular examination, health questionnaire and 12 lead ECG prior to commencing exercise.

The intervention will entail a six week programme, with 4 exercise sessions per week (40-60 min duration). The intervention will be a mixed high intensity interval training (HIIT) and resistance training (RT) programme. Prior to commencing the intervention, peak power (PP) for the HIIT (bike) intervention will be calculated. This will inform the power requirements for the first week of the protocol. Power requirements will increase by 2% per week thereafter. For the RT protocol, initial weight loading will be calculated based on the 'one rep max' (1RM). This will be increased by 1.5% each week.
The programme will run as follows:
Monday - aerobic HIIT . Five intervals (1,2,3,2,1 minutes) at 75% PP with 2 min rest periods at 30%PP
Tuesday - RT. Seated leg press; chest press; hip thrusters; lat pulldowns; upright rows; overhead press - 3 x sets of 10-12 reps. Weights 55% of the 1RM.
Thursday - speed HIIT - 10x 1 min intervals (905) PP with 2 min recovery intervals (30% PP)
Friday - strength RT. Repeat of Tuesday.

Prior to commencing, and after completion, participants will be invited to perform a full body DXA scan and oral glucose tolerance test. At the end of the intervention, participants will also be invited to complete a questionnaire assessing the feasibility, tolerability and cultural appropriateness of the intervention.
Intervention code [1] 296941 0
Lifestyle
Intervention code [2] 296967 0
Treatment: Other
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 300859 0
Hepatic insulin resistance, as measured by hyperinsulinaemic euglycacemic clamp with stable isotope dilution.
Timepoint [1] 300859 0
At baseline, and after achievement of 10% weight loss using the VLCD diet.
Primary outcome [2] 300860 0
Peripheral insulin resistance, as measured by hyperinsulinaemic euglycaemic clamp with stable isotope dilution.
Timepoint [2] 300860 0
At baseline, and after achievement of 10% weight loss using the VLCD diet.
Primary outcome [3] 300861 0
Change in beta cell function, as measured by arginine insulin secretion test.
Timepoint [3] 300861 0
At baseline, and after achievement of 10% weight loss using the VLCD diet.
Secondary outcome [1] 330982 0
Change in HbA1c (as measured by blood sample)
Timepoint [1] 330982 0
HbA1c will be measured at baseline, and after 10% weight loss has been achieved (no time limit)
Secondary outcome [2] 330983 0
Changes in resting energy expenditure (REE) using indirect calorimetry techniques with a hood calorimeter.
Timepoint [2] 330983 0
At baseline and after 10% weight loss achieved
Secondary outcome [3] 330984 0
24 hour glucose concentrations as determined by CGMS
Timepoint [3] 330984 0
At baseline and after 10% weight loss achieved
Secondary outcome [4] 330985 0
Surrogate indices of glucose metabolism (HOMA-IR and HOMA b; QUICKI; Matsuda). Composite secondary outcome.
Timepoint [4] 330985 0
At baseline and after 5% and 10% weight loss achieved
Secondary outcome [5] 330986 0
Actigraphy measures (including sleep and physical activity levels) using a wrist accelerometer. Composite secondary outcome
Timepoint [5] 330986 0
At baseline and after 10% weight loss achieved
Secondary outcome [6] 330987 0
Secondary exploratory analysis by ethnicity for all outcomes
Timepoint [6] 330987 0
At baseline and after 10% weight loss achieved
Secondary outcome [7] 330988 0
Assessment of recruitment rates through established links with primary care alongside barriers to recruitment (composite)
Timepoint [7] 330988 0
To be determined at recruitment
Secondary outcome [8] 331061 0
Tolerability of baseline investigations (as determined by questionnaire and Visual Analogue Scale)
Timepoint [8] 331061 0
Determined at baseline testing visit
Secondary outcome [9] 331062 0
Tolerability of intervention (as determined by questionnaire and Visual Analogue Scale)
Timepoint [9] 331062 0
To be determined at the completion of the study
Secondary outcome [10] 331063 0
Compliance with interventions (attendance at gym; self-reported dietary compliance; urinary ketones) - composite measure
Timepoint [10] 331063 0
To be determined at final study visit
Secondary outcome [11] 331064 0
Barriers to completion of intervention (as determined by survey)
Timepoint [11] 331064 0
To be determined at final study visit

Eligibility
Key inclusion criteria
1. Adult men aged 18-65
2. HbA1c 41-60mmol/mol
3. Identification as NZ European; Maori, Pacific or South Asian ethnicity
Minimum age
18 Years
Maximum age
65 Years
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
1. Unstable cardiovascular or respiratory disease
2. T2DM for >5 years, or on medication
3. Obstructive sleep apnoea
4. Chronic steroid use
5. Weight loss or gain of greater than or equal to 5kg within the preceding 3 months
6. Participants unable to take part in any component of the protocol

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
N/A - this is a prospective cohort study assessing the impact of a weight loss intervention on markers of glucose metabolism, with interaction by body composition (continuous variable).
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
N/A
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
N/A
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The primary analysis will be ANCOVA with main effects of randomised treatment, body composition (treated as a continuous variable), and their interaction. Similar analyses will be performed for the continuous secondary outcome variables. The ethnicity analysis will also include a categorical term for ethnicity.

A sample size of 20 has 80% power with Type 1 error rate of 5% to detect a baseline intervention tolerability of less than 56%, assuming tolerability of 80%. Using this sample size, insufficient compliance with the intervention in greater than or equal to 75% of participants will indicate a 95% confidence interval upper limit for adequate compliance of 48% in future research, which would be considered inadequate, and as such, is the threshold for making changes to the study protocol. Analysis of the recruitment rate shall also confirm the efficacy of planned recruitment measures for future studies.


Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
13/02/2017
Actual
3/04/2017
Date of last participant enrolment
Anticipated
29/06/2018
Actual
29/06/2018
Date of last data collection
Anticipated
30/08/2018
Actual
30/08/2018
Sample size
Target
20
Accrual to date
Final
15
Recruitment outside Australia
Country [1] 8602 0
New Zealand
State/province [1] 8602 0
Wellington

Funding & Sponsors
Funding source category [1] 295403 0
University
Name [1] 295403 0
University of Otago, Wellington Campus
Country [1] 295403 0
New Zealand
Funding source category [2] 295404 0
Charities/Societies/Foundations
Name [2] 295404 0
NZSSD (New Zealand Society for the Study of Diabetes)
Country [2] 295404 0
New Zealand
Funding source category [3] 295405 0
Government body
Name [3] 295405 0
Health Research Council
Country [3] 295405 0
New Zealand
Primary sponsor type
University
Name
University of Otago, Wellington Campus
Address
Dept of Medicine
University of Otago, Wellington Campus
PO Box 7343
Wellington South 6242
NZ
Country
New Zealand
Secondary sponsor category [1] 294227 0
None
Name [1] 294227 0
N/A
Address [1] 294227 0
N/A
Country [1] 294227 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296738 0
Health and Disability Ethics Committees (Ministry of Health, New Zealand)
Ethics committee address [1] 296738 0
Ethics committee country [1] 296738 0
New Zealand
Date submitted for ethics approval [1] 296738 0
16/11/2016
Approval date [1] 296738 0
21/12/2016
Ethics approval number [1] 296738 0
16/CEN/143/AM02

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

Contacts
Principal investigator
Name 68450 0
A/Prof Jeremy Krebs
Address 68450 0
Department of Medicine
University of Otago, Wellington Campus
PO Box 7343
Wellington South
New Zealand
Country 68450 0
New Zealand
Phone 68450 0
+6443855999
Fax 68450 0
Email 68450 0
[email protected]
Contact person for public queries
Name 68451 0
Patricia Whitfield
Address 68451 0
Department of Medicine
University of Otago, Wellington Campus
PO Box 7343
Wellington South
New Zealand
Country 68451 0
New Zealand
Phone 68451 0
+64212611437
Fax 68451 0
Email 68451 0
[email protected]
Contact person for scientific queries
Name 68452 0
Patricia Whitfield
Address 68452 0
Department of Medicine
University of Otago, Wellington Campus
PO Box 7343
Wellington South
New Zealand
Country 68452 0
New Zealand
Phone 68452 0
+64212611437
Fax 68452 0
Email 68452 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No/undecided IPD sharing reason/comment


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
No additional documents have been identified.