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

Study Overview
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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.

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

Conditions
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Polycystic Ovary Syndrome

Intervention / Treatment
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* Behavioral: 4x4 minutes high intensity interval training
* Behavioral: 10x1 minute high intensity interval training


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 4x4 minutes interval training<br>4x4 minutes high intensity interval training with 4 minute intervals | Behavioral: 4x4 minutes high intensity interval training<br>* 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.<br>* Other names: Aerobic exercise;|
| Experimental: 10x1 minute interval training<br>10x1 minute high intensity interval training with 1 minute intervals | Behavioral: 10x1 minute high intensity interval training<br>* 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.<br>* Other names: Aerobic exercise;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| mitochondrial oxidative phosphorylation capacity | assessed with high resolution respirometry | 16 weeks | 
| production of reactive oxygen species | assessed with high resolution respirometry | 16 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adipokine secretion |  | 16 weeks | 
| lipid droplet size in adipocytes |  | 16 weeks | 
| Whole-body fat oxydation rate |  | 16 weeks | 
| Insulin sensitivity | 2h oral glucose tolerance test (OGGT) | 16 weeks | 
| Whole-body peak oxygen uptake |  | 16 weeks | 
| Adipokine gene expression |  | 16 weeks | 
| Total protein abundance in adipose tissue | quantified using standard Western Blot method | 16 weeks | 
| blood markers of cardiometabolic health |  | 16 weeks | 
| Body composition | assessed by impedance scale (InBody) | 16 weeks | 
| blood pressure |  | 16 weeks | 
| endothelial function | measured by flow-mediated dilatation of the brachial artery | 16 weeks | 
| Intima media thickness | measured by ultrasound | 16 weeks | 
| Total cholesterol in blood |  | 16 weeks | 
| HDL cholesterol in blood |  | 16 weeks | 
| LDL cholesterol in blood |  | 16 weeks | 
| blood glucose |  | 16 weeks | 
| blood insulin |  | 16 weeks | 
| Glycosylated Hemoglobin (HbA1c) in blood |  | 16 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Exercise therapy, Adipose tissue, Mitochondria, Oxidative Phosphorylation