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
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
-
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.