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Trial registered on ANZCTR


Registration number
ACTRN12616000616471
Ethics application status
Approved
Date submitted
8/05/2016
Date registered
12/05/2016
Date last updated
13/07/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Effects of exercise timing throughout a day of prolonged sitting on blood glucose regulation
Scientific title
Effects of exercise timing throughout a day of prolonged sitting on blood glucose regulation in overweight/obese young adults
Secondary ID [1] 289139 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obesity 298643 0
Type 2 diabetes 298644 0
Condition category
Condition code
Metabolic and Endocrine 298705 298705 0 0
Metabolic disorders
Metabolic and Endocrine 298706 298706 0 0
Diabetes
Diet and Nutrition 298772 298772 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This is a randomised, two-condition crossover trial where participants will undergo 2x ~48 h experimental conditions. Each condition will be separated by a minimum 7-day washout period

For both conditions participants will attend the laboratory at ~5 pm on the evening prior to the main experimental trial day (day one) for fitting of a continuous glucose monitoring system and receive a standardised take-home meal for dinner. Participants will also be fitted with an an accelerometer and an inclinometer for measurement of physical activity levels prior and during each experimental condition. Food and activity diaries will also be completed by participants prior to either experimental condition.

On the main experimental trial day (day two) participants will arrive at the laboratory via taxi at ~0730 h. A catheter will be inserted in the antecubital vein of the non-dominant arm at 0800 h and remain in place until 1900 h. Participants will remain seated for the duration of the visit and blood samples will be collected at regular intervals. Identical meals will be provided at 0900 h, 1300 h and 1700 h. . Each meal will contain ~33% total energy intake for the day with a macronutrient profile of 50% from carbohydrates, 30% from fat and 20% from protein. Additionally, participants will perform 30 minutes of aerobic exercise at ~65% VO2max on a cycle ergometer. The timing of the exercise bout will depend on the experimental condition being undertaken. At 1900 h participants will return home via taxi and fast overnight.

Condition A: Exercise will be performed at 0800 h, prior to breakfast.

Condition B: Exercise will be performed at 1600 h, prior to dinner.

Participants will then return to the lab for a follow up (day three) at ~0730 and remain seated for the duration of the visit. A catheter will be inserted in the antecubital vein of the non-dominant arm at 0800 h and remain until 1600 h for serial blood sampling. Participants will be provided identical meals to day two at 0900 h and 1300 h. At 1630 h all monitoring devices will be removed.
Intervention code [1] 294676 0
Prevention
Intervention code [2] 294683 0
Behaviour
Comparator / control treatment
As this is a randomised, two-condition crossover trial, comparison will be made between the two experimental conditions (morning exercise and evening exercise).
Control group
Active

Outcomes
Primary outcome [1] 298223 0
Blood glucose area under the curve (using continuous glucose monitoring systems)
Timepoint [1] 298223 0
The duration of the intervention (~48 h monitoring period)
Secondary outcome [1] 323561 0
Plasma triglyceride area under the curve
Timepoint [1] 323561 0
Blood samples from hourly time points (and one time point 30 minutes following each meal) across laboratory visits (Day 2: 0800 h to 1900 h, Day 3: 0800 h to 1600 h)
Secondary outcome [2] 323562 0
Plasma insulin area under the curve
Timepoint [2] 323562 0
Blood samples from hourly time points (and one time point 30 minutes following each meal) across laboratory visits (Day 2: 0800 h to 1900 h, Day 3: 0800 h to 1600 h)
Secondary outcome [3] 323563 0
Appetite scores for hunger and satiety measured using a visual analogue scale on a laptop (composite outcome)
Timepoint [3] 323563 0
Every two hours during laboratory visits

Eligibility
Key inclusion criteria
Sedentary overweight or obese [body mass index (BMI) > 25 kg/m2 but < 45 kg/m2] adults with a familial history of type 2 diabetes (diagnosis in a first or second degree relative).
Minimum age
18 Years
Maximum age
30 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Pregnancy, use of carbohydrate or lipid-lowering medication, major illness/injury (acute or chronic), current smoker or use of nicotine replacement therapy or physical or major illness/physical problems (acute or chronic) that may limit their ability to participate in the intervention.

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)
Sealed envelopes containing order of conditions.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
An independent third party will prepare a computer-generated randomised sequence and sealed envelope containing the sequence.
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
Generalised linear mixed models with random intercepts will be used to compare the impact of each condition on the listed outcomes. We are currently in the process of verifying power calculations, this application will be updated prior to recruitment to include these calculations.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
16/05/2016
Actual
15/08/2016
Date of last participant enrolment
Anticipated
1/12/2018
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
25
Accrual to date
17
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment postcode(s) [1] 13221 0
3065 - Fitzroy

Funding & Sponsors
Funding source category [1] 293545 0
Charities/Societies/Foundations
Name [1] 293545 0
Novo-Nordisk Foundation
Country [1] 293545 0
Sweden
Primary sponsor type
Individual
Name
Professor John Hawley
Address
215 Spring Street-Level 5
Centre for Exercise and Nutrition
Mary MacKillop Institute for Health Research
Melbourne, VIC, 3000
Country
Australia
Secondary sponsor category [1] 292356 0
Individual
Name [1] 292356 0
Professor David Dunstan
Address [1] 292356 0
Baker IDI Heart and Diabetes Institute
PO Box 6492, Melbourne
Victoria 3004, Australia
Country [1] 292356 0
Australia
Secondary sponsor category [2] 292360 0
Individual
Name [2] 292360 0
Mr Samuel Pinto
Address [2] 292360 0
215 Spring Street-Level 5
Centre for Exercise and Nutrition
Mary MacKillop Institute for Health Research
Melbourne, VIC, 3000
Country [2] 292360 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294985 0
Australian Catholic University Human Research Ethics Committee
Ethics committee address [1] 294985 0
Ethics committee country [1] 294985 0
Australia
Date submitted for ethics approval [1] 294985 0
24/03/2016
Approval date [1] 294985 0
24/05/2016
Ethics approval number [1] 294985 0
2016-75H

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

Contacts
Principal investigator
Name 65618 0
Prof John Hawley
Address 65618 0
215 Spring Street-Level 5
Centre for Exercise and Nutrition
Mary MacKillop Institute for Health Research
Melbourne, VIC, 3000
Country 65618 0
Australia
Phone 65618 0
+61399533552
Fax 65618 0
Email 65618 0
John.Hawley@acu.edu.au
Contact person for public queries
Name 65619 0
Samuel Pinto
Address 65619 0
215 Spring Street-Level 5
Centre for Exercise and Nutrition
Mary MacKillop Institute for Health Research
Melbourne, VIC, 3000
Country 65619 0
Australia
Phone 65619 0
+61417315194
Fax 65619 0
Email 65619 0
samuel.pinto@myacu.edu.au
Contact person for scientific queries
Name 65620 0
John Hawley
Address 65620 0
215 Spring Street-Level 5
Centre for Exercise and Nutrition
Mary MacKillop Institute for Health Research
Melbourne, VIC, 3000
Country 65620 0
Australia
Phone 65620 0
+61399533552
Fax 65620 0
Email 65620 0
John.Hawley@acu.edu.au

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

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