Clinical trial NCT02943291: Adipose Tissue Function and Response to Exercise Training in Women With and Without Polycystic Ovary Syndrome
Official title: Adipose Tissue Function and Response to Exercise Training in Women With and Without Polycystic Ovary Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Polycystic Ovary Syndrome
Keywords: Exercise therapy
Adipose tissue
Mitochondria
Oxidative Phosphorylation
Lead sponsor: Norwegian University of Science and Technology
Sponsor class: OTHER
Collaborators: name: St. Olavs Hospital
name: Liverpool John Moores University
name: Australian Catholic University
First posted: 2016-10-24
Enrollment: 15
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: mitochondrial oxidative phosphorylation capacity
timeFrame: 16 weeks
measure: production of reactive oxygen species
timeFrame: 16 weeks
Secondary outcomes:
measure: Adipokine secretion
timeFrame: 16 weeks
measure: lipid droplet size in adipocytes
timeFrame: 16 weeks
measure: Whole-body fat oxydation rate
timeFrame: 16 weeks
measure: Insulin sensitivity
timeFrame: 16 weeks
measure: Whole-body peak oxygen uptake
timeFrame: 16 weeks
measure: Adipokine gene expression
timeFrame: 16 weeks
measure: Total protein abundance in adipose tissue
timeFrame: 16 weeks
measure: "blood markers of cardiometabolic health"
timeFrame: 16 weeks
measure: Body composition
timeFrame: 16 weeks
measure: blood pressure
timeFrame: 16 weeks
measure: endothelial function
timeFrame: 16 weeks
measure: Intima media thickness
timeFrame: 16 weeks
measure: Total cholesterol in blood
timeFrame: 16 weeks
measure: HDL cholesterol in blood
timeFrame: 16 weeks
measure: LDL cholesterol in blood
timeFrame: 16 weeks
measure: blood glucose
timeFrame: 16 weeks
measure: blood insulin
timeFrame: 16 weeks
measure: Glycosylated Hemoglobin (HbA1c) in blood
timeFrame: 16 weeks
Other outcomes:
Locations:
city: Melbourne
country: Australia
facility: Centre of Exercise and Nutrition, Mary MacKillop Institute for Health Research, AUC
city: Trondheim
country: Norway
facility: Department of circulation and medical imaging , NTNU
Study officials:
affiliation: Norwegian University of Science and Technology
name: Jorunn L Helbostad, phd prof
role: STUDY_DIRECTOR
References:
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.
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.
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.