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

NCT ID: NCT02943291

Last Updated: 2023-03-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-10-24

Study Completion Date

2022-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Polycystic Ovary Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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4x4 minutes interval training

4x4 minutes high intensity interval training with 4 minute intervals

Group Type EXPERIMENTAL

4x4 minutes high intensity interval training

Intervention Type BEHAVIORAL

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 interval training

10x1 minute high intensity interval training with 1 minute intervals

Group Type EXPERIMENTAL

10x1 minute high intensity interval training

Intervention Type BEHAVIORAL

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.

Interventions

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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.

Intervention Type BEHAVIORAL

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.

Intervention Type BEHAVIORAL

Other Intervention Names

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High-intensity exercise Aerobic exercise High-intensity exercise Aerobic exercise

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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St. Olavs Hospital

OTHER

Sponsor Role collaborator

Liverpool John Moores University

OTHER

Sponsor Role collaborator

Australian Catholic University

OTHER

Sponsor Role collaborator

Norwegian University of Science and Technology

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jorunn L Helbostad, phd prof

Role: STUDY_DIRECTOR

Norwegian University of Science and Technology

Locations

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Centre of Exercise and Nutrition, Mary MacKillop Institute for Health Research, AUC

Melbourne, , Australia

Site Status

Department of circulation and medical imaging , NTNU

Trondheim, , Norway

Site Status

Countries

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Australia Norway

References

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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.

Reference Type RESULT
PMID: 32848854 (View on PubMed)

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.

Reference Type RESULT
PMID: 35329952 (View on PubMed)

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.

Reference Type RESULT
PMID: 33841184 (View on PubMed)

Other Identifiers

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2016/545

Identifier Type: -

Identifier Source: org_study_id

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