Condition category
Nutritional, Metabolic, Endocrine
Date applied
22/12/2008
Date assigned
23/01/2009
Last edited
28/08/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.jeanhailes.org.au/research/closed-projects/916-pcos-and-insulin-resistance-study

Contact information

Type

Scientific

Primary contact

Prof Helena Teede

ORCID ID

Contact details

SHPM
Monash Institute of Health Services Research
Monash Medical Centre
246 Clayton Road
Clayton
Melbourne
3168
Australia
+61 (0)3 9594 7545
helena.teede@med.monash.edu.au

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

A prospective cohort study examining the effect of 12 weeks of intensive endurance exercise on insulin sensitivity and muscle insulin signalling in overweight women with or without polycystic ovary syndrome (PCOS)

Acronym

PCOS

Study hypothesis

Women with polycystic ovary syndrome (PCOS) have both intrinsic insulin resistance and extrinsic obesity-related insulin resistance mediated via different mechanisms. Exercise is an effective intervention decreasing central adiposity reducing extrinsic insulin resistance and improving symptoms.

Ethics approval

Received from the Southern Health Human Ethics Committee in March 2005

Study design

Prospective cohort non-randomised un-blinded controlled trial

Primary study design

Interventional

Secondary study design

Non randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Condition

Polycystic ovary syndrome

Intervention

Both PCOS and non-PCOS women underwent the same study protocol. From baseline, participants in the two groups undertook a 12 week programme of supervised intensified endurance exercise (1 hr/day; 3 x per week). Two different exercise sessions alternated, performing 1 hour of moderate intensity treadmill walking to elicit work rates of 70% of maximal oxygen consumption (VO2max) or 75 - 85% of maximal heart rate (HRmax). These were adjusted as fitness improved. Alternate sessions involve high intensity exercise with intermittent walking up an incline with 6 - 8 repetitions (5 minutes walking, 2 minutes recoveries) targeting 90 - 100% VO2max or 95 - 100% HRmax. Participants progress to 8 repetitions by the 4th week, with 1 minute of recovery. After 12 weeks of exercise all baseline measurements were repeated.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Effects on insulin resistance, measured at baseline and after 12 weeks of exercise.

Secondary outcome measures

1. Clinical symptom improvement
2. Insulin signalling
3. Mitochondrial function

Measured at baseline and after 12 weeks of exercise.

Overall trial start date

01/03/2005

Overall trial end date

01/03/2008

Reason abandoned

Eligibility

Participant inclusion criteria

1. Overweight women (body mass index [BMI] greater than 27 kg/m^2)
2. Aged 18 - 40 years with PCOS and without
3. Diagnosed from a history of perimenarchal onset of irregular cycles (less than 21 days or greater than 35 days)
4. Clinical manifestations of hyperandrogenism (hirsutism, acne) or biochemical hyperandrogenism with elevation of at least one circulating ovarian androgen (1990 National Institute of Health [NIH] criteria)

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

30

Participant exclusion criteria

1. BMI less than 27 kg/m^2
2. Other concurrent medical conditions
3. Ongoing use of the oral contraceptive pill (OCP)
4. Pregnancy or desire for pregnancy
5. Secondary causes of amenorrhoea and hyperandrogenism

Recruitment start date

01/03/2005

Recruitment end date

01/03/2008

Locations

Countries of recruitment

Australia

Trial participating centre

SHPM, Monash Institute of Health Services Research
Melbourne
3168
Australia

Sponsor information

Organisation

Southern Health (Australia)

Sponsor details

246 Clayton Road
Clayton
Melbourne
3168
Australia
+61 (0)3 9594 6666
malar.thiagarajan@southernhealth.org.au

Sponsor type

Government

Website

http://www.southernhealth.org.au

Funders

Funder type

University/education

Funder name

Monash University (Australia) - New Investigator Award 2005

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

1. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/22246378

Publication citations

  1. Results

    Hutchison SK, Teede HJ, Rachoń D, Harrison CL, Strauss BJ, Stepto NK, Effect of exercise training on insulin sensitivity, mitochondria and computed tomography muscle attenuation in overweight women with and without polycystic ovary syndrome., Diabetologia, 2012, 55, 5, 1424-1434, doi: 10.1007/s00125-011-2442-8.

Additional files

Editorial Notes