Adipose Tissue Function and Response to Exercise Training in Women With and Without Polycystic Ovary Syndrome

Polycystic Ovary Syndrome Clinical Trial

— HIT-FAT  

Official title:

Adipose Tissue Function and Response to Exercise Training in Women With and Without Polycystic Ovary Syndrome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02943291
• Other study ID #: 2016/545
• Status: Completed
• Phase: N/A
• Start date: October 24, 2016
• Est. completion date: January 31, 2022

Study information

• Verified date: March 2023
• Source: Norwegian University of Science and Technology
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: January 31, 2022
• Est. primary completion date: January 31, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Polycystic Ovary Syndrome
• Syndrome

Intervention

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.
• 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.

Locations

Country	Name	City	State
Australia	Centre of Exercise and Nutrition, Mary MacKillop Institute for Health Research, AUC	Melbourne
Norway	Department of circulation and medical imaging , NTNU	Trondheim

Sponsors (4)

Lead Sponsor	Collaborator
Norwegian University of Science and Technology	Australian Catholic University, Liverpool John Moores University, St. Olavs Hospital

Countries where clinical trial is conducted

Australia,  Norway, 

References & Publications (3)

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/jcm110616 — View 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. — View 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/fph — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	mitochondrial oxidative phosphorylation capacity	assessed with high resolution respirometry	16 weeks
Primary	production of reactive oxygen species	assessed with high resolution respirometry	16 weeks
Secondary	Adipokine secretion		16 weeks
Secondary	lipid droplet size in adipocytes		16 weeks
Secondary	Whole-body fat oxydation rate		16 weeks
Secondary	Insulin sensitivity	2h oral glucose tolerance test (OGGT)	16 weeks
Secondary	Whole-body peak oxygen uptake		16 weeks
Secondary	Adipokine gene expression		16 weeks
Secondary	Total protein abundance in adipose tissue	quantified using standard Western Blot method	16 weeks
Secondary	"blood markers of cardiometabolic health"		16 weeks
Secondary	Body composition	assessed by impedance scale (InBody)	16 weeks
Secondary	blood pressure		16 weeks
Secondary	endothelial function	measured by flow-mediated dilatation of the brachial artery	16 weeks
Secondary	Intima media thickness	measured by ultrasound	16 weeks
Secondary	Total cholesterol in blood		16 weeks
Secondary	HDL cholesterol in blood		16 weeks
Secondary	LDL cholesterol in blood		16 weeks
Secondary	blood glucose		16 weeks
Secondary	blood insulin		16 weeks
Secondary	Glycosylated Hemoglobin (HbA1c) in blood		16 weeks