Polycystic Ovary SyndromeHIT-FATNCT02943291
Adipose Tissue Function and Response to Exercise Training in Women With and Without Polycystic Ovary Syndrome
A study testing 4x4 minutes high intensity interval training and 10x1 minute high intensity interval training in people with Polycystic Ovary Syndrome, run by Norwegian University of Science and Technology at 2 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Polycystic Ovary Syndrome
- What is being tested?
- 4x4 minutes high intensity interval training and 10x1 minute high intensity interval training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 24 Oct 2016to 31 Jan 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- eumenorrheic
- matching PCOC group in IMPROV-IT study (NCT02419482)
- Living nearby St Olavs Hospital, Trondheim, Norway
Who cannot join
- 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
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
Australia1 site
Centre of Exercise and Nutrition, Mary MacKillop Institute for Health Research, AUC
Melbourne
Norway1 site
Department of circulation and medical imaging , NTNU
Trondheim, 7491
About this study
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.
- Conditions
- Polycystic Ovary Syndrome
- Being tested
- 4x4 minutes high intensity interval training, 10x1 minute high intensity interval training
- Keywords
- Exercise therapy, Adipose tissue, Mitochondria, Oxidative Phosphorylation
- Medical subject headings
- Polycystic Ovary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
4x4 minutes high intensity interval trainingBehavioural
Also called High-intensity exercise, Aerobic exercise
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.
10x1 minute high intensity interval trainingBehavioural
Also called High-intensity exercise, Aerobic exercise
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.
| Study group | Role | What they receive |
|---|---|---|
| 4x4 minutes interval training | Experimental | 4x4 minutes high intensity interval training with 4 minute intervals Receives: Behavioral: 4x4 minutes high intensity interval training |
| 10x1 minute interval training | Experimental | 10x1 minute high intensity interval training with 1 minute intervals Receives: Behavioral: 10x1 minute high intensity interval training |
What is being measured
The primary outcome is the main question the study is designed to answer.
mitochondrial oxidative phosphorylation capacity
assessed with high resolution respirometry
Measured: 16 weeks
production of reactive oxygen species
assessed with high resolution respirometry
Measured: 16 weeks
Secondary outcomes (18)
Adipokine secretion
Measured: 16 weeks
lipid droplet size in adipocytes
Measured: 16 weeks
Whole-body fat oxydation rate
Measured: 16 weeks
Insulin sensitivity
2h oral glucose tolerance test (OGGT)
Measured: 16 weeks
Whole-body peak oxygen uptake
Measured: 16 weeks
Adipokine gene expression
Measured: 16 weeks
Total protein abundance in adipose tissue
quantified using standard Western Blot method
Measured: 16 weeks
"blood markers of cardiometabolic health"
Measured: 16 weeks
Body composition
assessed by impedance scale (InBody)
Measured: 16 weeks
blood pressure
Measured: 16 weeks
endothelial function
measured by flow-mediated dilatation of the brachial artery
Measured: 16 weeks
Intima media thickness
measured by ultrasound
Measured: 16 weeks
Total cholesterol in blood
Measured: 16 weeks
HDL cholesterol in blood
Measured: 16 weeks
LDL cholesterol in blood
Measured: 16 weeks
blood glucose
Measured: 16 weeks
blood insulin
Measured: 16 weeks
Glycosylated Hemoglobin (HbA1c) in blood
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2016 (estimated)
- Study start24 Oct 2016
- Primary completion31 Jan 2022
- Study completion31 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Polycystic Ovary SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Norwegian University of Science and Technology
- Sponsor type
- University, hospital or other
- Collaborators
- St. Olavs Hospital, Liverpool John Moores University, Australian Catholic University
- Responsible party
- Sponsor
- Investigators
- Jorunn L Helbostad, phd prof, Study director, Norwegian University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02943291
- Sponsor's protocol ID
- 2016/545
- Acronym
- HIT-FAT
- Status last verified
- Mar 2023
- First submitted
- 21 Oct 2016
- Last updated
- 17 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
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.
PubMed 32848854Kiel 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.
PubMed 35329952Lionett 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.
PubMed 33841184
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adipose Tissue Function and Response to Exercise Training in Women With and Without Polycystic Ovary Syndrome
- ClinicalTrials.gov ID
- NCT02943291
- Acronym / sponsor ID
- HIT-FAT / 2016/545
- Conditions
- Polycystic Ovary Syndrome
- Keywords
- Exercise therapy, Adipose tissue, Mitochondria, Oxidative Phosphorylation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Norwegian University of Science and TechnologyUniversity, hospital or other
- Collaborators
- St. Olavs Hospital, Liverpool John Moores University, Australian Catholic University
- Study start
- 24 Oct 2016 (actual)
- Primary completion
- 31 Jan 2022 (actual)
- Study completion
- 31 Jan 2022 (actual)
- First posted
- 24 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 4x4 minutes interval training | Experimental | Behavioral: 4x4 minutes high intensity interval training4x4 minutes high intensity interval training with 4 minute intervals |
| 10x1 minute interval training | Experimental | Behavioral: 10x1 minute high intensity interval training10x1 minute high intensity interval training with 1 minute intervals |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- eumenorrheic
- matching PCOC group in IMPROV-IT study (NCT02419482)
- Living nearby St Olavs Hospital, Trondheim, Norway
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 4x4 minutes high intensity interval trainingAlso: High-intensity exercise, Aerobic exerciseTreadmill 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. | Behavioural | 4x4 minutes interval training |
| 10x1 minute high intensity interval trainingAlso: High-intensity exercise, Aerobic exerciseTreadmill 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. | Behavioural | 10x1 minute interval training |
Primary outcome
mitochondrial oxidative phosphorylation capacity
Time frame: 16 weeks
assessed with high resolution respirometry
production of reactive oxygen species
Time frame: 16 weeks
assessed with high resolution respirometry
18 secondary outcomes
Adipokine secretion
Time frame: 16 weeks
lipid droplet size in adipocytes
Time frame: 16 weeks
Whole-body fat oxydation rate
Time frame: 16 weeks
Insulin sensitivity
Time frame: 16 weeks
Whole-body peak oxygen uptake
Time frame: 16 weeks
Adipokine gene expression
Time frame: 16 weeks
Total protein abundance in adipose tissue
Time frame: 16 weeks
"blood markers of cardiometabolic health"
Time frame: 16 weeks
Body composition
Time frame: 16 weeks
blood pressure
Time frame: 16 weeks
endothelial function
Time frame: 16 weeks
Intima media thickness
Time frame: 16 weeks
Total cholesterol in blood
Time frame: 16 weeks
HDL cholesterol in blood
Time frame: 16 weeks
LDL cholesterol in blood
Time frame: 16 weeks
blood glucose
Time frame: 16 weeks
blood insulin
Time frame: 16 weeks
Glycosylated Hemoglobin (HbA1c) in blood
Time frame: 16 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2023.
- Results publication: PubMed 32848854Lionett 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.
- Results publication: PubMed 35329952Kiel 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.
- Results publication: PubMed 33841184Lionett 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jorunn L Helbostad, phd prof study director
Norwegian University of Science and Technology
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 4x4 minutes high intensity interval training and 10x1 minute high intensity interval training in people with Polycystic Ovary Syndrome, run by Norwegian University of Science and Technology at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Australia, Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
mitochondrial oxidative phosphorylation capacity (time frame: 16 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02943291, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2023; AzTrials last refreshed its copy on 31 Oct 2026.