Adipose Tissue Function and Response to Exercise Training in Women With and Without Polycystic Ovary Syndrome
HIT-FAT
1 other identifier
interventional
15
2 countries
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Oct 2016
Longer than P75 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 21, 2016
CompletedFirst Posted
Study publicly available on registry
October 24, 2016
CompletedStudy Start
First participant enrolled
October 24, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 31, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
January 31, 2022
CompletedMarch 17, 2023
March 1, 2023
5.3 years
October 21, 2016
March 14, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
mitochondrial oxidative phosphorylation capacity
assessed with high resolution respirometry
16 weeks
production of reactive oxygen species
assessed with high resolution respirometry
16 weeks
Secondary Outcomes (18)
Adipokine secretion
16 weeks
lipid droplet size in adipocytes
16 weeks
Whole-body fat oxydation rate
16 weeks
Insulin sensitivity
16 weeks
Whole-body peak oxygen uptake
16 weeks
- +13 more secondary outcomes
Study Arms (2)
4x4 minutes interval training
EXPERIMENTAL4x4 minutes high intensity interval training with 4 minute intervals
10x1 minute interval training
EXPERIMENTAL10x1 minute high intensity interval training with 1 minute intervals
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- eumenorrheic
- matching PCOC group in IMPROV-IT study (NCT02419482)
- Living nearby St Olavs Hospital, Trondheim, Norway
You may not qualify if:
- Signs of hyperandrogenism
- Regular high intensity endurance (two or more times per week of vigorous exercise).
- On-going pregnancy
- Hormonal contraception
- Breastfeeding within 24 weeks
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Norwegian University of Science and Technologylead
- St. Olavs Hospitalcollaborator
- Liverpool John Moores Universitycollaborator
- Australian Catholic Universitycollaborator
Study Sites (2)
Centre of Exercise and Nutrition, Mary MacKillop Institute for Health Research, AUC
Melbourne, Australia
Department of circulation and medical imaging , NTNU
Trondheim, 7491, Norway
Related Publications (3)
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.
PMID: 32848854RESULTKiel 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.
PMID: 35329952RESULTLionett 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.
PMID: 33841184RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Jorunn L Helbostad, phd prof
Norwegian University of Science and Technology
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 21, 2016
First Posted
October 24, 2016
Study Start
October 24, 2016
Primary Completion
January 31, 2022
Study Completion
January 31, 2022
Last Updated
March 17, 2023
Record last verified: 2023-03