Low glycaemic index diet and endometrial cancer risk in polycystic ovary syndrome
| ISRCTN | ISRCTN86420258 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN86420258 |
| Secondary identifying numbers | 1 |
- 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
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
| Study design | Pilot randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Not Specified |
| Scientific title | Low glycaemic index diet and endometrial cancer risk in polycystic ovary syndrome |
| Study objectives | To 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) studied | Polycystic ovary syndrome |
| Intervention | 1. 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 type | Other |
| Primary outcome measure | 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. |
| Secondary outcome measures | No secondary outcome measures |
| Overall study start date | 01/07/2006 |
| Completion date | 30/06/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target number of participants | 40 |
| Key inclusion criteria | 1. 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 criteria | 1. 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 enrolment | 01/07/2006 |
| Date of final enrolment | 30/06/2008 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
D Floor
Nottingham
NG7 2UH
United Kingdom
NG7 2UH
United Kingdom
Sponsor information
Cancer Research UK (UK)
Charity
Charity
Lincoln's Inn Fields
London
WC2A 3PX
United Kingdom
| karen.kerr@cancer.org.uk | |
| Website | http://www.cancerresearchuk.org |
"ROR" |
https://ror.org/054225q67 |
Funders
Funder type
Charity
Cancer Research UK (UK) (ref: C20654/A7380)
Private sector organisation / Other non-profit organizations
Private sector organisation / Other non-profit organizations
- Alternative name(s)
- CR_UK, Cancer Research UK - London, CRUK
- Location
- United Kingdom
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 01/09/2009 | Yes | No | |
| Results article | results | 08/03/2011 | Yes | No |
Editorial Notes
01/10/2018: Publication reference added.
