Adipose Tissue Function and Response to Exercise Training in Women With and Without Polycystic Ovary Syndrome (HIT-FAT)

March 14, 2023 updated by: Norwegian University of Science and Technology
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

15

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
      • Melbourne, Australia
        • Centre of Exercise and Nutrition, Mary MacKillop Institute for Health Research, AUC
  • Norway
      • Trondheim, Norway, 7491
        • Department of circulation and medical imaging , NTNU

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 4x4 minutes interval training
4x4 minutes high intensity interval training with 4 minute intervals
Behavioral: 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.
Other Names:
  • High-intensity exercise
  • Aerobic exercise
Experimental: 10x1 minute interval training
10x1 minute high intensity interval training with 1 minute intervals
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.
Other Names:
  • High-intensity exercise
  • Aerobic exercise

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Norwegian University of Science and Technology

Collaborators

St. Olavs Hospital
Liverpool John Moores University
Australian Catholic University

Investigators

  • Study Director: Jorunn L Helbostad, phd prof, Norwegian University of Science and Technology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 24, 2016

Primary Completion (Actual)

January 31, 2022

Study Completion (Actual)

January 31, 2022

Study Registration Dates

First Submitted

October 21, 2016

First Submitted That Met QC Criteria

October 21, 2016

First Posted (Estimate)

October 24, 2016

Study Record Updates

Last Update Posted (Actual)

March 17, 2023

Last Update Submitted That Met QC Criteria

March 14, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2016/545

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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