- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02943291
Adipose Tissue Function and Response to Exercise Training in Women With and Without Polycystic Ovary Syndrome (HIT-FAT)
March 14, 2023 updated by: Norwegian University of Science and Technology
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 Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
15
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 45 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- eumenorrheic
- matching PCOC group in IMPROV-IT study (NCT02419482)
- Living nearby St Olavs Hospital, Trondheim, Norway
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 4x4 minutes interval training
4x4 minutes high intensity interval training with 4 minute intervals
|
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.
Other Names:
|
Experimental: 10x1 minute interval training
10x1 minute high intensity interval training with 1 minute intervals
|
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.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
mitochondrial oxidative phosphorylation capacity
Time Frame: 16 weeks
|
assessed with high resolution respirometry
|
16 weeks
|
production of reactive oxygen species
Time Frame: 16 weeks
|
assessed with high resolution respirometry
|
16 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Adipokine secretion
Time Frame: 16 weeks
|
16 weeks
|
|
lipid droplet size in adipocytes
Time Frame: 16 weeks
|
16 weeks
|
|
Whole-body fat oxydation rate
Time Frame: 16 weeks
|
16 weeks
|
|
Insulin sensitivity
Time Frame: 16 weeks
|
2h oral glucose tolerance test (OGGT)
|
16 weeks
|
Whole-body peak oxygen uptake
Time Frame: 16 weeks
|
16 weeks
|
|
Adipokine gene expression
Time Frame: 16 weeks
|
16 weeks
|
|
Total protein abundance in adipose tissue
Time Frame: 16 weeks
|
quantified using standard Western Blot method
|
16 weeks
|
"blood markers of cardiometabolic health"
Time Frame: 16 weeks
|
16 weeks
|
|
Body composition
Time Frame: 16 weeks
|
assessed by impedance scale (InBody)
|
16 weeks
|
blood pressure
Time Frame: 16 weeks
|
16 weeks
|
|
endothelial function
Time Frame: 16 weeks
|
measured by flow-mediated dilatation of the brachial artery
|
16 weeks
|
Intima media thickness
Time Frame: 16 weeks
|
measured by ultrasound
|
16 weeks
|
Total cholesterol in blood
Time Frame: 16 weeks
|
16 weeks
|
|
HDL cholesterol in blood
Time Frame: 16 weeks
|
16 weeks
|
|
LDL cholesterol in blood
Time Frame: 16 weeks
|
16 weeks
|
|
blood glucose
Time Frame: 16 weeks
|
16 weeks
|
|
blood insulin
Time Frame: 16 weeks
|
16 weeks
|
|
Glycosylated Hemoglobin (HbA1c) in blood
Time Frame: 16 weeks
|
16 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Director: Jorunn L Helbostad, phd prof, Norwegian University of Science and Technology
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 24, 2016
Primary Completion (Actual)
January 31, 2022
Study Completion (Actual)
January 31, 2022
Study Registration Dates
First Submitted
October 21, 2016
First Submitted That Met QC Criteria
October 21, 2016
First Posted (Estimate)
October 24, 2016
Study Record Updates
Last Update Posted (Actual)
March 17, 2023
Last Update Submitted That Met QC Criteria
March 14, 2023
Last Verified
March 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2016/545
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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