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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 27 March 2023
Main ID:  NCT02943291
Date of registration: 21/10/2016
Prospective Registration: Yes
Primary sponsor: Norwegian University of Science and Technology
Public title: Adipose Tissue Function and Response to Exercise Training in Women With and Without Polycystic Ovary Syndrome HIT-FAT
Scientific title: Adipose Tissue Function and Response to Exercise Training in Women With and Without Polycystic Ovary Syndrome
Date of first enrolment: October 24, 2016
Target sample size: 15
Recruitment status: Completed
URL:  https://clinicaltrials.gov/show/NCT02943291
Study type:  Interventional
Study design:  Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Single (Outcomes Assessor).  
Phase:  N/A
Countries of recruitment
Australia Norway
Contacts
Name:     Jorunn L Helbostad, phd prof
Address: 
Telephone:
Email:
Affiliation:  Norwegian University of Science and Technology
Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 45 Years
Gender: Female
Health Condition(s) or Problem(s) studied
Polycystic Ovary Syndrome
Intervention(s)
Behavioral: 10x1 minute high intensity interval training
Behavioral: 4x4 minutes high intensity interval training
Primary Outcome(s)
production of reactive oxygen species [Time Frame: 16 weeks]
mitochondrial oxidative phosphorylation capacity [Time Frame: 16 weeks]
Secondary Outcome(s)
Adipokine gene expression [Time Frame: 16 weeks]
HDL cholesterol in blood [Time Frame: 16 weeks]
Insulin sensitivity [Time Frame: 16 weeks]
Total protein abundance in adipose tissue [Time Frame: 16 weeks]
"blood markers of cardiometabolic health" [Time Frame: 16 weeks]
blood glucose [Time Frame: 16 weeks]
Adipokine secretion [Time Frame: 16 weeks]
Total cholesterol in blood [Time Frame: 16 weeks]
blood insulin [Time Frame: 16 weeks]
Whole-body peak oxygen uptake [Time Frame: 16 weeks]
endothelial function [Time Frame: 16 weeks]
Glycosylated Hemoglobin (HbA1c) in blood [Time Frame: 16 weeks]
LDL cholesterol in blood [Time Frame: 16 weeks]
lipid droplet size in adipocytes [Time Frame: 16 weeks]
Whole-body fat oxydation rate [Time Frame: 16 weeks]
Intima media thickness [Time Frame: 16 weeks]
blood pressure [Time Frame: 16 weeks]
Body composition [Time Frame: 16 weeks]
Secondary ID(s)
2016/545
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
St. Olavs Hospital
Australian Catholic University
Liverpool John Moores University
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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