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Clinical Trials/NCT02943291
NCT02943291
Completed
Not Applicable

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

Norwegian University of Science and Technology2 sites in 2 countries15 target enrollmentOctober 24, 2016

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Polycystic Ovary Syndrome
Sponsor
Norwegian University of Science and Technology
Enrollment
15
Locations
2
Primary Endpoint
mitochondrial oxidative phosphorylation capacity
Status
Completed
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 24, 2016
End Date
January 31, 2022
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

mitochondrial oxidative phosphorylation capacity

Time Frame: 16 weeks

assessed with high resolution respirometry

production of reactive oxygen species

Time Frame: 16 weeks

assessed with high resolution respirometry

Secondary Outcomes

  • blood glucose(16 weeks)
  • Adipokine secretion(16 weeks)
  • lipid droplet size in adipocytes(16 weeks)
  • Whole-body peak oxygen uptake(16 weeks)
  • Adipokine gene expression(16 weeks)
  • blood pressure(16 weeks)
  • Intima media thickness(16 weeks)
  • HDL cholesterol in blood(16 weeks)
  • Body composition(16 weeks)
  • Glycosylated Hemoglobin (HbA1c) in blood(16 weeks)
  • Whole-body fat oxydation rate(16 weeks)
  • Insulin sensitivity(16 weeks)
  • Total protein abundance in adipose tissue(16 weeks)
  • "blood markers of cardiometabolic health"(16 weeks)
  • blood insulin(16 weeks)
  • endothelial function(16 weeks)
  • Total cholesterol in blood(16 weeks)
  • LDL cholesterol in blood(16 weeks)

Study Sites (2)

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