Adipose Tissue Function and Response to Exercise Training in Women With and Without Polycystic Ovary Syndrome (HIT-FAT)
Primary Purpose
Polycystic Ovary Syndrome
Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
4x4 minutes high intensity interval training
10x1 minute high intensity interval training
Sponsored by
About this trial
This is an interventional treatment trial for Polycystic Ovary Syndrome focused on measuring Exercise therapy, Adipose tissue, Mitochondria, Oxidative Phosphorylation
Eligibility Criteria
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
Sites / Locations
- Centre of Exercise and Nutrition, Mary MacKillop Institute for Health Research, AUC
- Department of circulation and medical imaging , NTNU
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
4x4 minutes interval training
10x1 minute interval training
Arm Description
4x4 minutes high intensity interval training with 4 minute intervals
10x1 minute high intensity interval training with 1 minute intervals
Outcomes
Primary Outcome Measures
mitochondrial oxidative phosphorylation capacity
assessed with high resolution respirometry
production of reactive oxygen species
assessed with high resolution respirometry
Secondary Outcome Measures
Adipokine secretion
lipid droplet size in adipocytes
Whole-body fat oxydation rate
Insulin sensitivity
2h oral glucose tolerance test (OGGT)
Whole-body peak oxygen uptake
Adipokine gene expression
Total protein abundance in adipose tissue
quantified using standard Western Blot method
"blood markers of cardiometabolic health"
Body composition
assessed by impedance scale (InBody)
blood pressure
endothelial function
measured by flow-mediated dilatation of the brachial artery
Intima media thickness
measured by ultrasound
Total cholesterol in blood
HDL cholesterol in blood
LDL cholesterol in blood
blood glucose
blood insulin
Glycosylated Hemoglobin (HbA1c) in blood
Full Information
NCT ID
NCT02943291
First Posted
October 21, 2016
Last Updated
March 14, 2023
Sponsor
Norwegian University of Science and Technology
Collaborators
St. Olavs Hospital, Liverpool John Moores University, Australian Catholic University
1. Study Identification
Unique Protocol Identification Number
NCT02943291
Brief Title
Adipose Tissue Function and Response to Exercise Training in Women With and Without Polycystic Ovary Syndrome
Acronym
HIT-FAT
Official Title
Adipose Tissue Function and Response to Exercise Training in Women With and Without Polycystic Ovary Syndrome
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
October 24, 2016 (Actual)
Primary Completion Date
January 31, 2022 (Actual)
Study Completion Date
January 31, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Norwegian University of Science and Technology
Collaborators
St. Olavs Hospital, Liverpool John Moores University, Australian Catholic University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Polycystic Ovary Syndrome
Keywords
Exercise therapy, Adipose tissue, Mitochondria, Oxidative Phosphorylation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
15 (Actual)
8. Arms, Groups, and Interventions
Arm Title
4x4 minutes interval training
Arm Type
Experimental
Arm Description
4x4 minutes high intensity interval training with 4 minute intervals
Arm Title
10x1 minute interval training
Arm Type
Experimental
Arm Description
10x1 minute high intensity interval training with 1 minute intervals
Intervention Type
Behavioral
Intervention Name(s)
4x4 minutes high intensity interval training
Other Intervention Name(s)
High-intensity exercise, Aerobic exercise
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
10x1 minute high intensity interval training
Other Intervention Name(s)
High-intensity exercise, Aerobic exercise
Intervention Description
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.
Primary Outcome Measure Information:
Title
mitochondrial oxidative phosphorylation capacity
Description
assessed with high resolution respirometry
Time Frame
16 weeks
Title
production of reactive oxygen species
Description
assessed with high resolution respirometry
Time Frame
16 weeks
Secondary Outcome Measure Information:
Title
Adipokine secretion
Time Frame
16 weeks
Title
lipid droplet size in adipocytes
Time Frame
16 weeks
Title
Whole-body fat oxydation rate
Time Frame
16 weeks
Title
Insulin sensitivity
Description
2h oral glucose tolerance test (OGGT)
Time Frame
16 weeks
Title
Whole-body peak oxygen uptake
Time Frame
16 weeks
Title
Adipokine gene expression
Time Frame
16 weeks
Title
Total protein abundance in adipose tissue
Description
quantified using standard Western Blot method
Time Frame
16 weeks
Title
"blood markers of cardiometabolic health"
Time Frame
16 weeks
Title
Body composition
Description
assessed by impedance scale (InBody)
Time Frame
16 weeks
Title
blood pressure
Time Frame
16 weeks
Title
endothelial function
Description
measured by flow-mediated dilatation of the brachial artery
Time Frame
16 weeks
Title
Intima media thickness
Description
measured by ultrasound
Time Frame
16 weeks
Title
Total cholesterol in blood
Time Frame
16 weeks
Title
HDL cholesterol in blood
Time Frame
16 weeks
Title
LDL cholesterol in blood
Time Frame
16 weeks
Title
blood glucose
Time Frame
16 weeks
Title
blood insulin
Time Frame
16 weeks
Title
Glycosylated Hemoglobin (HbA1c) in blood
Time Frame
16 weeks
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jorunn L Helbostad, phd prof
Organizational Affiliation
Norwegian University of Science and Technology
Official's Role
Study Director
Facility Information:
Facility Name
Centre of Exercise and Nutrition, Mary MacKillop Institute for Health Research, AUC
City
Melbourne
Country
Australia
Facility Name
Department of circulation and medical imaging , NTNU
City
Trondheim
ZIP/Postal Code
7491
Country
Norway
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
32848854
Citation
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.
Results Reference
result
PubMed Identifier
35329952
Citation
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.
Results Reference
result
PubMed Identifier
33841184
Citation
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.
Results Reference
result
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Adipose Tissue Function and Response to Exercise Training in Women With and Without Polycystic Ovary Syndrome
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