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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02943291




Registration number
NCT02943291
Ethics application status
Date submitted
21/10/2016
Date registered
24/10/2016
Date last updated
17/06/2019

Titles & IDs
Public title
Adipose Tissue Function and Response to Exercise Training in Women With and Without Polycystic Ovary Syndrome
Scientific title
Adipose Tissue Function and Response to Exercise Training in Women With and Without Polycystic Ovary Syndrome
Secondary ID [1] 0 0
2016/545
Universal Trial Number (UTN)
Trial acronym
HIT-FAT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Polycystic Ovary Syndrome 0 0
Condition category
Condition code
Other 0 0 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above
Reproductive Health and Childbirth 0 0 0 0
Other reproductive health and childbirth disorders
Metabolic and Endocrine 0 0 0 0
Other endocrine disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Behaviour - 4x4 minutes high intensity interval training
Behaviour - 10x1 minute high intensity interval training

Experimental: 4x4 minutes interval training - 4x4 minutes high intensity interval training with 4 minute intervals

Experimental: 10x1 minute interval training - 10x1 minute high intensity interval training with 1 minute intervals


Behaviour: 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.

Behaviour: 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.

Intervention code [1] 0 0
Behaviour
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
mitochondrial oxidative phosphorylation capacity - assessed with high resolution respirometry
Timepoint [1] 0 0
16 weeks
Primary outcome [2] 0 0
production of reactive oxygen species - assessed with high resolution respirometry
Timepoint [2] 0 0
16 weeks
Secondary outcome [1] 0 0
Adipokine secretion
Timepoint [1] 0 0
16 weeks
Secondary outcome [2] 0 0
lipid droplet size in adipocytes
Timepoint [2] 0 0
16 weeks
Secondary outcome [3] 0 0
Whole-body fat oxydation rate
Timepoint [3] 0 0
16 weeks
Secondary outcome [4] 0 0
Insulin sensitivity - 2h oral glucose tolerance test (OGGT)
Timepoint [4] 0 0
16 weeks
Secondary outcome [5] 0 0
Whole-body peak oxygen uptake
Timepoint [5] 0 0
16 weeks
Secondary outcome [6] 0 0
Adipokine gene expression
Timepoint [6] 0 0
16 weeks
Secondary outcome [7] 0 0
Total protein abundance in adipose tissue - quantified using standard Western Blot method
Timepoint [7] 0 0
16 weeks
Secondary outcome [8] 0 0
"blood markers of cardiometabolic health"
Timepoint [8] 0 0
16 weeks
Secondary outcome [9] 0 0
Body composition - assessed by impedance scale (InBody)
Timepoint [9] 0 0
16 weeks
Secondary outcome [10] 0 0
blood pressure
Timepoint [10] 0 0
16 weeks
Secondary outcome [11] 0 0
endothelial function - measured by flow-mediated dilatation of the brachial artery
Timepoint [11] 0 0
16 weeks
Secondary outcome [12] 0 0
Intima media thickness - measured by ultrasound
Timepoint [12] 0 0
16 weeks
Secondary outcome [13] 0 0
Total cholesterol in blood
Timepoint [13] 0 0
16 weeks
Secondary outcome [14] 0 0
HDL cholesterol in blood
Timepoint [14] 0 0
16 weeks
Secondary outcome [15] 0 0
LDL cholesterol in blood
Timepoint [15] 0 0
16 weeks
Secondary outcome [16] 0 0
blood glucose
Timepoint [16] 0 0
16 weeks
Secondary outcome [17] 0 0
blood insulin
Timepoint [17] 0 0
16 weeks
Secondary outcome [18] 0 0
Glycosylated Hemoglobin (HbA1c) in blood
Timepoint [18] 0 0
16 weeks

Eligibility
Key inclusion criteria
- eumenorrheic

- matching PCOC group in IMPROV-IT study (NCT02419482)

- Living nearby St Olavs Hospital, Trondheim, Norway
Minimum age
18 Years
Maximum age
45 Years
Gender
Females
Can healthy volunteers participate?
No
Key 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 design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Centre of Exercise and Nutrition, Mary MacKillop Institute for Health Research, AUC - Melbourne
Recruitment postcode(s) [1] 0 0
- Melbourne
Recruitment outside Australia
Country [1] 0 0
Norway
State/province [1] 0 0
Trondheim

Funding & Sponsors
Primary sponsor type
Other
Name
Norwegian University of Science and Technology
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
St. Olavs Hospital
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Liverpool John Moores University
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
Australian Catholic University
Address [3] 0 0
Country [3] 0 0

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/show/NCT02943291
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Jorunn L Helbostad, phd prof
Address 0 0
Norwegian University of Science and Technology
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Trine Moholdt, phd
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
trine.moholdt@ntnu.no
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT02943291