Register a trial

Please note the ANZCTR will be unattended from Friday 20 December 2024 for the holidays. The Registry will re-open on Tuesday 7 January 2025. Submissions and updates will not be processed during that time.

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02943291




Registration number
NCT02943291
Ethics application status
Date submitted
21/10/2016
Date registered
24/10/2016

Titles & IDs
Public title
Adipose Tissue Function and Response to Exercise Training in Women With and Without Polycystic Ovary Syndrome
Scientific title
Adipose Tissue Function and Response to Exercise Training in Women With and Without Polycystic Ovary Syndrome
Secondary ID [1] 0 0
2016/545
Universal Trial Number (UTN)
Trial acronym
HIT-FAT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Polycystic Ovary Syndrome 0 0
Condition category
Condition code
Reproductive Health and Childbirth 0 0 0 0
Other reproductive health and childbirth disorders
Metabolic and Endocrine 0 0 0 0
Other endocrine disorders
Other 0 0 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
BEHAVIORAL - 4x4 minutes high intensity interval training
BEHAVIORAL - 10x1 minute high intensity interval training

Experimental: 4x4 minutes interval training - 4x4 minutes high intensity interval training with 4 minute intervals

Experimental: 10x1 minute interval training - 10x1 minute high intensity interval training with 1 minute intervals


BEHAVIORAL: 4x4 minutes high intensity interval training
Treadmill running/walking with 10 minutes warm-up at 60-70% of maximum heart rate, 4x4 minute intervals at 90-95% of maximum heart rate separated by 3-minutes active pauses at 60-70% of maximum heart rate, and 3 minutes cool-down.

BEHAVIORAL: 10x1 minute high intensity interval training
Treadmill running/walking with 10 minutes warm-up at 60-70% of maximum heart rate, ten 1-minute intervals at maximal intensity (that can be performed for one minute), separated by 1-minutes active pauses at 60-70% of maximum heart rate, and 3 minutes cool-down.
Intervention code [1] 0 0
BEHAVIORAL
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
mitochondrial oxidative phosphorylation capacity
Timepoint [1] 0 0
16 weeks
Primary outcome [2] 0 0
production of reactive oxygen species
Timepoint [2] 0 0
16 weeks
Secondary outcome [1] 0 0
Adipokine secretion
Timepoint [1] 0 0
16 weeks
Secondary outcome [2] 0 0
lipid droplet size in adipocytes
Timepoint [2] 0 0
16 weeks
Secondary outcome [3] 0 0
Whole-body fat oxydation rate
Timepoint [3] 0 0
16 weeks
Secondary outcome [4] 0 0
Insulin sensitivity
Timepoint [4] 0 0
16 weeks
Secondary outcome [5] 0 0
Whole-body peak oxygen uptake
Timepoint [5] 0 0
16 weeks
Secondary outcome [6] 0 0
Adipokine gene expression
Timepoint [6] 0 0
16 weeks
Secondary outcome [7] 0 0
Total protein abundance in adipose tissue
Timepoint [7] 0 0
16 weeks
Secondary outcome [8] 0 0
"blood markers of cardiometabolic health"
Timepoint [8] 0 0
16 weeks
Secondary outcome [9] 0 0
Body composition
Timepoint [9] 0 0
16 weeks
Secondary outcome [10] 0 0
blood pressure
Timepoint [10] 0 0
16 weeks
Secondary outcome [11] 0 0
endothelial function
Timepoint [11] 0 0
16 weeks
Secondary outcome [12] 0 0
Intima media thickness
Timepoint [12] 0 0
16 weeks
Secondary outcome [13] 0 0
Total cholesterol in blood
Timepoint [13] 0 0
16 weeks
Secondary outcome [14] 0 0
HDL cholesterol in blood
Timepoint [14] 0 0
16 weeks
Secondary outcome [15] 0 0
LDL cholesterol in blood
Timepoint [15] 0 0
16 weeks
Secondary outcome [16] 0 0
blood glucose
Timepoint [16] 0 0
16 weeks
Secondary outcome [17] 0 0
blood insulin
Timepoint [17] 0 0
16 weeks
Secondary outcome [18] 0 0
Glycosylated Hemoglobin (HbA1c) in blood
Timepoint [18] 0 0
16 weeks

Eligibility
Key inclusion criteria
* eumenorrheic
* matching PCOC group in IMPROV-IT study (NCT02419482)
* Living nearby St Olavs Hospital, Trondheim, Norway
Minimum age
18 Years
Maximum age
45 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
* Signs of hyperandrogenism
* Regular high intensity endurance (two or more times per week of vigorous exercise).
* Concurrent treatments (insulin sensitizers or drugs known to affect gonadotropin or ovulation, with a wash out period of 1 months prior to inclusion).
* On-going pregnancy
* Hormonal contraception
* Breastfeeding within 24 weeks

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
24/10/2016
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
31/01/2022
Sample size
Target
Accrual to date
Final
15
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Centre of Exercise and Nutrition, Mary MacKillop Institute for Health Research, AUC - Melbourne
Recruitment postcode(s) [1] 0 0
- Melbourne
Recruitment outside Australia
Country [1] 0 0
Norway
State/province [1] 0 0
Trondheim

Funding & Sponsors
Primary sponsor type
Other
Name
Norwegian University of Science and Technology
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
St. Olavs Hospital
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Liverpool John Moores University
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
Australian Catholic University
Address [3] 0 0
Country [3] 0 0

Ethics approval
Ethics application status

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

Contacts
Principal investigator
Name 0 0
Jorunn L Helbostad, phd prof
Address 0 0
Norwegian University of Science and Technology
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

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


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents



Results not provided in https://clinicaltrials.gov/study/NCT02943291