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Completed

NCT Number: NCT02943291

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

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.

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Key information

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

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

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

4x4 minutes high intensity interval training

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.

Other names: High-intensity exercise, Aerobic exercise

10x1 minute high intensity interval training

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.

Other names: High-intensity exercise, Aerobic exercise

Primary outcomes

  1. mitochondrial oxidative phosphorylation capacity

    Time frame: 16 weeks

    assessed with high resolution respirometry

  2. production of reactive oxygen species

    Time frame: 16 weeks

    assessed with high resolution respirometry

Secondary outcomes

  1. Adipokine secretion

    Time frame: 16 weeks

  2. lipid droplet size in adipocytes

    Time frame: 16 weeks

  3. Whole-body fat oxydation rate

    Time frame: 16 weeks

  4. Insulin sensitivity

    Time frame: 16 weeks

    2h oral glucose tolerance test (OGGT)

  5. Whole-body peak oxygen uptake

    Time frame: 16 weeks

  6. Adipokine gene expression

    Time frame: 16 weeks

  7. Total protein abundance in adipose tissue

    Time frame: 16 weeks

    quantified using standard Western Blot method

  8. "blood markers of cardiometabolic health"

    Time frame: 16 weeks

  9. Body composition

    Time frame: 16 weeks

    assessed by impedance scale (InBody)

  10. blood pressure

    Time frame: 16 weeks

  11. endothelial function

    Time frame: 16 weeks

    measured by flow-mediated dilatation of the brachial artery

  12. Intima media thickness

    Time frame: 16 weeks

    measured by ultrasound

  13. Total cholesterol in blood

    Time frame: 16 weeks

  14. HDL cholesterol in blood

    Time frame: 16 weeks

  15. LDL cholesterol in blood

    Time frame: 16 weeks

  16. blood glucose

    Time frame: 16 weeks

  17. blood insulin

    Time frame: 16 weeks

  18. Glycosylated Hemoglobin (HbA1c) in blood

    Time frame: 16 weeks

Sponsors and collaborators

Lead sponsor

Norwegian University of Science and Technology

Other

Collaborators

  • Australian Catholic University
  • Liverpool John Moores University
  • St. Olavs Hospital

Registry information

Acronym: HIT-FAT

Important dates

Study start
2016
Primary completion
2022
Study completion
2022
First posted
Oct 24, 2016
Registry last updated
Mar 17, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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