Low glycaemic index diet and endometrial cancer risk in polycystic ovary syndrome

ISRCTN ISRCTN86420258
DOI https://doi.org/10.1186/ISRCTN86420258
Protocol serial number 1
Sponsor Cancer Research UK (UK)
Funder Cancer Research UK (UK) (ref: C20654/A7380)
Submission date
18/08/2008
Registration date
13/10/2008
Last edited
01/10/2018
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Nutritional, Metabolic, Endocrine
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr William Atiomo
Scientific

D Floor
East Block
School of Human Development
Department of Obstetrics and Gynaecology
University of Nottingham
Queens Medical Centre
Nottingham
NG7 2UH
United Kingdom

Study information

Primary study designInterventional
Study designPilot randomised controlled trial
Secondary study designRandomised controlled trial
Scientific titleLow glycaemic index diet and endometrial cancer risk in polycystic ovary syndrome
Study objectivesTo evaluate the feasibility of a definitive trial to test whether in obese anovulatory women with polycystic ovary syndrome (PCOS) a low glycaemic index (GI) diet compared with a 600 kcal deficit hypo-caloric healthy eating approach results in a greater reduction in such risk factors for endometrial cancer as oestrogen levels, insulin resistance, anovulation, obesity, androgens, endometrial thickness, and prevalence of endometrial hyperplasia and pro-oncogenic expression of molecular markers for such endometrial cancer as Pten, p27, Kras and Cyclin D1.
Ethics approval(s)Derbyshire Research Ethics Committee. Date of approval: 20/06/2006 (ref: 06/Q2401/76)
Health condition(s) or problem(s) studiedPolycystic ovary syndrome
Intervention1. Baseline clinical interview, assessing menstrual history, current gynaecological, medical and surgical history, past medical, surgical and gynaecological history, family and social history
2. Baseline measurement of body mass index, waist circumference, hip circumference, Ferriman galway score and blood pressure
3. Baseline venepunctures for oestradiol, insulin, glucose, insulin resistance, testosterone, sex hormone binding globulin (SHBG) and luteinising hormone (LH) levels
4. Baseline food diary
5. Baseline pelvic ultrasound scan for endometrial thickness
6. Baseline endometrial biopsy for endometrial hyperplasia and Pten, p27, Kras and Cyclin D1 expression
7. Randomisation to low glycaemic diet or a 600 kcal deficit hypocaloric healthy eating approach
8. Monthly diet classes for the participants, to be taught by a trained dietician for 6 months
9. Monthly assessment of compliance using a food diary
10. Month 6: Repeat assessment of frequency of menstrual cycles, body mass index, waist circumference, insulin, glucose, insulin resistance, testosterone, SHBG, oestradiol, endometrial thickness on pelvic ultrasound, and endometrial biopsy for endometrial hyperplasia and expression of Pten, p27, Kras and Cyclin D1

Women will be flagged at the office of national statistics for the future development of endometrial cancer.
Intervention typeOther
Primary outcome measure(s)

As this is a pilot study, we do not have a specific biological primary outcome measure. We will however be looking at measures and standard deviations of possible primary outcomes (see below) to inform the definitive trial. The focus of this pilot will be the assessment of the feasibility of the study (eligibility, recruitment, compliance and drop out rate) to help us determine whether an investment in a definitive trial would be value for money.

Possible primary outcomes in the definitive trial include:
1. Change in oestradiol levels, assessed at baseline and Month 6
2. Change in SHBG levels, assessed at baseline and Month 6
3. Change in insulin resistance, assessed at baseline and Month 6
4. Change in expression of Pten, p27, Kras and Cyclin D1 on endometrial biopsy, assessed at baseline and Month 6
5. Prevalence of endometrial hyperplasia on endometrial biopsy at baseline compared with Month 6
6. Proportion of women who have resumed normal menstrual cyclicity by Month 6
7. Reduction in endometrial thickness, assessed at baseline and Month 6
8. Reduction in body mass index by Month 6
9. Change in testosterone levels, assessed at baseline and Month 6
10. In the definitive trial we propose to flag women up at the Office for National Statistics for development of endometrial cancer, however, data collection will be commenced in this pilot study. We do however recognise that even the definitive study may not be powered to detect any significant differences.

Key secondary outcome measure(s)

No secondary outcome measures

Completion date30/06/2008

Eligibility

Participant type(s)Patient
Age groupAdult
SexFemale
Target sample size at registration40
Key inclusion criteria1. An objective diagnosis of polycystic ovary syndrome using the Rotterdam criteria
2. Oligo or amenorrhoea
3. Age above 35
4. Body mass index above 30
5. Patient consent
6. Ability to attend dietary classes at monthly intervals
7. Able to be assessed by pelvic ultrasound imaging and endometrial biopsy
Key exclusion criteria1. Previous or current history of any cancer
2. Inability to attend diet classes at monthly intervals
3. Regular menstrual periods
4. Age below 35
5. Body mass index below 30
6. Unable to be assessed by pelvic ultrasound imaging and endometrial biopsy
Date of first enrolment01/07/2006
Date of final enrolment30/06/2008

Locations

Countries of recruitment

  • United Kingdom
  • England

Study participating centre

D Floor
Nottingham
NG7 2UH
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to shareNo
IPD sharing plan summary
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 08/03/2011 Yes No
Protocol article protocol 01/09/2009 Yes No

Editorial Notes

01/10/2018: Publication reference added.

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