The impact of obesity and weight loss on the endometrium

ISRCTN	ISRCTN17241389
DOI	https://doi.org/10.1186/ISRCTN17241389
Secondary identifying numbers	Version 4 - 02.08.13

Submission date: 10/03/2014
Registration date: 23/04/2014
Last edited: 29/01/2019

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Cancer

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English Summary

Background and study aims
Endometrial cancer, or cancer of the lining of the womb, has become the most common cancer of the reproductive tract in British women. Obese women are at increased risk of the disease and are also more likely to die from it. The recent obesity epidemic means that more women than ever before are developing the disease. Endometrial cancer can usually be cured by surgery but for obese or elderly women, surgery may be dangerous. It also renders a woman infertile. There is an urgent need to develop preventative strategies for an increasingly obese female population. Understanding more about the mechanisms linking obesity and endometrial cancer will help the development of these.
Bariatric surgery (reduction of stomach capacity by e.g. gastric banding) results in rapid weight loss: 10-15% excess body weight will be lost in six weeks with resolution of body mass index (BMI) to within the normal/overweight range (BMI 25-30) by 12 months. Non-surgical weight loss management can be effective but produces much slower results. Looking at the changes in the endometrium following weight loss may help us understand what causes endometrial cancer to develop and from there we can then look at what can be done to stop endometrial cancer developing.

Who can participate?
We will recruit around 100-150 morbidly obese (BMI>40) women aged 18 years or more who have been offered bariatric surgery or a non-surgical weight loss programme.

What does the study involve?
Both groups of women will have blood samples and a sample of the lining of the womb (endometrial biopsy) taken at recruitment. The women will then undergo surgery or follow their weight loss programme. All women will attend a follow up appointment 2 and 12 months later when a further blood sample and sample of the lining of the womb will be taken. Women will be asked to report their general health while in the study by filling out a questionnaire. They will also be asked about their quality of life before and after weight loss.

What are the possible benefits and risks of participating?
There will be no direct benefit to many of those taking part, but there should be benefits for future women with endometrial cancer because this study will help us investigate why endometrial cancer develops. Some patients with underlying endometrial pathology will be identified by taking part in the study, and for these women, further investigations and treatment may be necessary.

Where is the study run from?
Patients will be recruited from the Obesity Clinic at Salford Royal Hospital and followed up at St Marys Hospital in Manchester (UK).

When is study starting and how long is it expected to run for?
The study started April 2012 and is likely to complete April 2016.

Who is funding the study?
The research fellow salaries are funded by Central Manchester University Hospitals NHS Foundation Trust and the project costs are funded by NIHR (UK).

Who is the main contact?
Dr Emma Crosbie
emma.crosbie@manchester.ac.uk

Contact information

Dr Emma Crosbie
Scientific

Institute of Cancer Sciences
St. Mary's Hospital
Oxford Road
Manchester
M13 9WL
United Kingdom

Study information

Study design	Prospective cohort study
Primary study design	Observational
Secondary study design	Cohort study
Study setting(s)	Hospital
Study type	Screening
Participant information sheet	Not available in web format, please use the contact details to request a patient information sheet
Scientific title	The impact of obesity and weight loss on the endometrium: a prospective cohort study
Study hypothesis	Obesity and weight loss affect endometrial proliferation
Ethics approval(s)	NRES Committee North West - Lancaster, 23/01/2012, ref: 12/NW/0050
Condition	Endometrial cancer
Intervention	Medical history, height and weight (to calculate BMI) hip and waist measurements a blood sample and an endometrial biopsy will be taken at the baseline clinic visit. At 6 weeks and 9-12 months post-surgery or post-initiation of medical treatment these will all be repeated. A general health questionnaire will be completed at the baseline clinic visit and at 12 months follow up.
Intervention type	Other
Primary outcome measure	Ki67 expression by the endometrium (a marker of proliferation) measured at baseline and post weight loss (endometrial biopsy).
Secondary outcome measures	Endometrial markers, physiological markers and changes in menstrual function and mental wellbeing measured at baseline and post weight loss (blood sample and questionnaire).
Overall study start date	01/04/2012
Overall study end date	01/04/2016

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Female
Target number of participants	150
Participant inclusion criteria	1. Female aged 18 years or more 2. Undergoing bariatric surgery or commencing medical weight management therapy 3. Written informed consent to participate in the study
Participant exclusion criteria	1. Previous hysterectomy 2. Intrauterine device (IUD) or levonorgestrel intrauterine system (LNG-IUS) in situ 3. Previous endometrial ablation 4. Treatment with tamoxifen 5. Pregnancy
Recruitment start date	01/04/2012
Recruitment end date	01/04/2016

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Institute of Cancer Sciences

Manchester
M13 9WL
United Kingdom

Sponsor information

Central Manchester University Hospitals NHS Foundation Trust (CMFT) (UK)
Hospital/treatment centre

Oxford Road
Manchester
M13 9WL
England
United Kingdom

"ROR"	https://ror.org/00he80998

Funders

Funder type

Hospital/treatment centre

Central Manchester University Hospitals NHS Foundation Trust (research fellow salaries)
Government organisation / Local government

Alternative name(s): MFT
Location: United Kingdom

National Institute for Health Research (project costs)
Government organisation / National government

Alternative name(s): National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR
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?
Abstract results	results presented at the annual meeting of the Blair Bell Research Society:	01/11/2015		No	No
Results article	results	01/02/2019		Yes	No

Editorial Notes

29/01/2019: Publication reference added.
15/05/2018: Publication reference added.