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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
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Scientific title
Adipose Tissue Function and Response to Exercise Training in Women With and Without Polycystic Ovary Syndrome
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Secondary ID [1]
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2016/545
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Universal Trial Number (UTN)
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Trial acronym
HIT-FAT
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Polycystic Ovary Syndrome
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Condition category
Condition code
Reproductive Health and Childbirth
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Other reproductive health and childbirth disorders
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Metabolic and Endocrine
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Other endocrine disorders
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Other
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Research that is not of generic health relevance and not applicable to specific health categories listed above
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Intervention/exposure
Study type
Interventional
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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.
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Intervention code [1]
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BEHAVIORAL
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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mitochondrial oxidative phosphorylation capacity
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Assessment method [1]
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assessed with high resolution respirometry
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Timepoint [1]
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16 weeks
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Primary outcome [2]
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production of reactive oxygen species
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Assessment method [2]
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assessed with high resolution respirometry
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Timepoint [2]
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16 weeks
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Secondary outcome [1]
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Adipokine secretion
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Assessment method [1]
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0
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Timepoint [1]
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16 weeks
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Secondary outcome [2]
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lipid droplet size in adipocytes
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Assessment method [2]
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0
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Timepoint [2]
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16 weeks
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Secondary outcome [3]
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Whole-body fat oxydation rate
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Assessment method [3]
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0
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Timepoint [3]
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16 weeks
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Secondary outcome [4]
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Insulin sensitivity
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Assessment method [4]
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2h oral glucose tolerance test (OGGT)
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Timepoint [4]
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0
16 weeks
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Secondary outcome [5]
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Whole-body peak oxygen uptake
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Assessment method [5]
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0
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Timepoint [5]
0
0
16 weeks
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Secondary outcome [6]
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Adipokine gene expression
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Assessment method [6]
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0
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Timepoint [6]
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16 weeks
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Secondary outcome [7]
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Total protein abundance in adipose tissue
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Assessment method [7]
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quantified using standard Western Blot method
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Timepoint [7]
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16 weeks
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Secondary outcome [8]
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"blood markers of cardiometabolic health"
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Assessment method [8]
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0
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Timepoint [8]
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16 weeks
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Secondary outcome [9]
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Body composition
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Assessment method [9]
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assessed by impedance scale (InBody)
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Timepoint [9]
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16 weeks
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Secondary outcome [10]
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blood pressure
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Assessment method [10]
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0
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Timepoint [10]
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16 weeks
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Secondary outcome [11]
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endothelial function
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Assessment method [11]
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measured by flow-mediated dilatation of the brachial artery
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Timepoint [11]
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16 weeks
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Secondary outcome [12]
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Intima media thickness
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Assessment method [12]
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measured by ultrasound
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Timepoint [12]
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16 weeks
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Secondary outcome [13]
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Total cholesterol in blood
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Assessment method [13]
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0
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Timepoint [13]
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16 weeks
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Secondary outcome [14]
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HDL cholesterol in blood
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Assessment method [14]
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0
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Timepoint [14]
0
0
16 weeks
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Secondary outcome [15]
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LDL cholesterol in blood
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Assessment method [15]
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0
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Timepoint [15]
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16 weeks
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Secondary outcome [16]
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blood glucose
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Assessment method [16]
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0
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Timepoint [16]
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16 weeks
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Secondary outcome [17]
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blood insulin
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Assessment method [17]
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0
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Timepoint [17]
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16 weeks
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Secondary outcome [18]
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Glycosylated Hemoglobin (HbA1c) in blood
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Assessment method [18]
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0
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Timepoint [18]
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16 weeks
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Eligibility
Key inclusion criteria
* eumenorrheic
* matching PCOC group in IMPROV-IT study (NCT02419482)
* Living nearby St Olavs Hospital, Trondheim, Norway
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Minimum age
18
Years
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Maximum age
45
Years
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Sex
Females
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Can healthy volunteers participate?
No
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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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people assessing the outcomes
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Intervention assignment
Parallel
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Other design features
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Phase
NA
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
24/10/2016
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
31/01/2022
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Sample size
Target
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Accrual to date
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Final
15
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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Centre of Exercise and Nutrition, Mary MacKillop Institute for Health Research, AUC - Melbourne
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Recruitment postcode(s) [1]
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- Melbourne
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Recruitment outside Australia
Country [1]
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Norway
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State/province [1]
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Trondheim
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Funding & Sponsors
Primary sponsor type
Other
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Name
Norwegian University of Science and Technology
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Address
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Country
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Other collaborator category [1]
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Other
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Name [1]
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St. Olavs Hospital
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Address [1]
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Country [1]
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Other collaborator category [2]
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Other
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Name [2]
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Liverpool John Moores University
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Address [2]
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Country [2]
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0
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Other collaborator category [3]
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Other
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Name [3]
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Australian Catholic University
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Address [3]
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Country [3]
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Ethics approval
Ethics application status
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Summary
Brief summary
The primary aim of this trial is to investigate adipose tissue function in women with and without polycystic ovary syndrome (PCOS). PCOS is a common endocrine disorder in young women. The pathogenesis behind PCOS is complex and only partly understood, and deeper mechanistic insight is needed. Insulin resistance is a central feature of PCOS, and recent studies have suggested that this is linked to aberrant adipose tissue function. Exercise training has been found to improve the symptoms in PCOS, but we need more knowledge about why. While processes involved in skeletal muscle oxidative remodeling are well described, it is to a large extent unknown whether the oxidative capacity of human adipose tissue is modified by endurance training. The women included in this study will be matched (for body mass index, body weight, and age) to participants in another study. This will enable the investigators to do a comparison between cases (women with PCOS) and controls (women without PCOS) at baseline, and to assess the responses to exercise training in adipose tissue.
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Trial website
https://clinicaltrials.gov/study/NCT02943291
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Trial related presentations / publications
Lionett S, Kiel IA, Camera DM, Vanky E, Parr EB, Lydersen S, Hawley JA, Moholdt T. Circulating and Adipose Tissue miRNAs in Women With Polycystic Ovary Syndrome and Responses to High-Intensity Interval Training. Front Physiol. 2020 Jul 30;11:904. doi: 10.3389/fphys.2020.00904. eCollection 2020. Kiel IA, Jones H, Lionett S, Rosbjorgen R, Lydersen S, Vanky E, Moholdt T. Cardiovascular Health Does Not Change Following High-Intensity Interval Training in Women with Polycystic Ovary Syndrome. J Clin Med. 2022 Mar 15;11(6):1626. doi: 10.3390/jcm11061626. Lionett S, Kiel IA, Rosbjorgen R, Lydersen S, Larsen S, Moholdt T. Absent Exercise-Induced Improvements in Fat Oxidation in Women With Polycystic Ovary Syndrome After High-Intensity Interval Training. Front Physiol. 2021 Mar 24;12:649794. doi: 10.3389/fphys.2021.649794. eCollection 2021.
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Public notes
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Contacts
Principal investigator
Name
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Jorunn L Helbostad, phd prof
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Address
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Norwegian University of Science and Technology
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Undecided
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No/undecided IPD sharing reason/comment
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Type
Citations or Other Details
Journal
Lionett S, Kiel IA, Camera DM, Vanky E, Parr EB, L...
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More Details
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Journal
Kiel IA, Jones H, Lionett S, Rosbjorgen R, Lyderse...
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More Details
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Journal
Lionett S, Kiel IA, Rosbjorgen R, Lydersen S, Lars...
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More Details
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Results not provided in
https://clinicaltrials.gov/study/NCT02943291