Plain English Summary
Background and study aims
Polycystic ovary syndrome (PCOS) is one of the most common hormone disorders that affects women of childbearing age. The symptoms of PCOS include enlarged (polycystic) ovaries, high levels of male hormones (hyperandrogenism), irregular periods (anovulation), infertility and miscarriage. Furthermore, women with PCOS have a high risk of developing metabolic disorders such as diabetes and heart disease. Lifestyle changes (weight loss and exercise) are an important part of treatment. However, many patients fail to lose weight by lifestyle changes or quickly regain weight. Structured lifestyle management with long-term support may improve patients’ compliance. The main aim of this study is to evaluate an individualized diet and exercise program for weight loss in overweight women with PCOS.
Who can participate?
Overweight/obese women aged 18-40 with PCOS
What does the study involve?
Participants are randomly allocated into two groups. Group A starts with an active treatment of an individualized diet and exercise program, and Group B begins with self-treatment (lifestyle change on their own). After four months, Group A switches to self-treatment and Group B to active treatment. After eight months, there is a follow-up period of four months with self-treatment for all participants. Investigations at the start of the study and after 4 and 12 months include a blood sample for measurement of hormone levels, vital signs, BMI and waist/hip measurements, quality of life assessment, gynecological examination, measurement of body composition, assessment of liver fat by CT scan, and endometrial, muscle and subcutaneous fat samples.
What are the possible benefits and risks of participating?
All patients undergo a general health examination, gynaecological evaluation and investigations of body composition, which are important information for their own health. If they succeed at losing weight this should be beneficial for future health and fertility. The potential risks of participating in this study are expected to be small. Endometrial biopsies (samples of the lining of the womb) are collected under local anaesthetic, which usually provides good pain relief, but occasionally can give short-term pain and some discomfort. Fat and muscle biopsies are taken according to a standard sampling technique under local anaesthetic. The sampling can cause bruising and soreness, and in extremely rare cases, infection. A small scar may occur after sampling. The total dose of radiation from the scans is relatively low.
Where is the study run from?
Women’s Health Research Unit, Karolinska University Hospital, Stockholm, Sweden
When is the study starting and how long is it expected to run for?
January 2012 to May 2016
Who is funding the study?
Swedish Medical Research Council
Who is the main contact?
Prof. Angelica L Hirschberg
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
2012-10-10
Study information
Scientific title
Metabolic and hormonal effects of weight loss in patients with polycystic ovary syndrome - a prospective randomised controlled trial
Acronym
Study hypothesis
A structured lifestyle program with long-term support could lead to sustained weight loss and improved reproductive and metabolic health.
Ethics approval
Regional Ethics Committee, Stockholm, 29/02/2012, ref: 2012/146-31/3
Study design
Prospective randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
GP practices
Trial type
Quality of life
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet
Condition
Polycystic ovary syndrome (PCOS)
Intervention
Active treatment - individualized diet and exercise program:
The diet aims to reduce the intake of fast carbohydrates, in favour of foods with low glycemic index (GI), giving a smoother postprandial glucose curve and lower insulin levels. A protein drink (Natural Balance Shake, from Indevex), consisting of a protein mix from natural foods for a total of 65 kcal is taken 30 minutes before breakfast, lunch and dinner to reduce hunger and prevent excess intake of other foods. Food diary, weight and waist/hip measurements are used for evaluation of the diet. The exercise program is based on each individuals condition, interest and experience and may include walking (with or without poles), water aerobics or fitness at Friskis & Svettis. Pedometers, exercise diary and pulse measurement are used for evaluation. Follow-up is performed in groups twice a week under the guidance of a lifestyle coach. Furthermore, individual coaching takes place via telephone and/or e-mail four times per month.
Self treatment - lifestyle change on their own but including the protein drink
Individual follow-up is performed twice per month at the clinic with control of weight and waist/hip measurements.
Intervention type
Behavioural
Phase
Drug names
Primary outcome measure
Weight change
Added 04/12/2019: measured in kilograms and a percentage at baseline, 4 and 12 months
Secondary outcome measures
Current secondary outcome measures as of 04/12/2019:
1. Menstrual function defined as menstrual cycle type (regular cycle, oligomenorrhoea and amenorrhea) reported by participants at baseline, 4 and 12 months as well as changes to the proportion of study participants in each category at all review points
2. Body composition (total fat percentage, trunk fat mass and lean body mass) assessed by a dual-energy X-ray absorptiometry (DEXA) scanner at baseline, 4 and 12 months as well as changes to the body composition between baseline and the review points
3. Insulin sensitivity assessed by the oral glucose tolerance test, fasting insulin levels and the HOMA-index at baseline, 4 and 12 months and changes to these between baseline and the review points
4. Psychological well being as assessed by the Psychological General Well Being Index (PGWBI) at baseline, 4 and 12 months and changes to the PGWBI between baseline and the review points
5. Sleep pattern, measured by total sleep time, bedtime and wake up time and sleep efficiency. This is recorded using an Actigraph for 7 consecutive days at baseline and 4 months.
6. Metabolic status as measured by blood lipids, as well as metabolomic analysis of proteins specific for satiety and hunger. This will be done at baseline, 4 and 12 months
7. Liver fat as determined by MRI in a subset of patients at baseline and after 4 and 12 months
Previous secondary outcome measures:
1. Menstrual function
2. Body composition
3. Insulin sensitivity in the endometrium, muscle and fat tissue
Overall trial start date
01/01/2012
Overall trial end date
28/05/2016
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. All criteria for the diagnosis of PCOS should be met (anovulation, hyperandrogenism, polycystic ovaries)
2. 18-40 years
3. BMI between 27 and 38
4. No medication or hormone-containing contraceptives
5. If any kind of hormonal contraception, acceptance for three months of wash-out period before entering the study
6. Accepting a non-hormonal method of contraception such as condoms, IUD during the study or be sterilized
7. Willing to give informed consent in writing
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
40 women with complete investigations
Participant exclusion criteria
1. Smoking
2. Use of hormone-containing contraceptives
3. Chronic Illness
4. Ongoing medication
Recruitment start date
01/01/2012
Recruitment end date
31/12/2014
Locations
Countries of recruitment
Sweden
Trial participating centre
Karolinska Institutet
Stockholm
SE 171 76
Sweden
Sponsor information
Organisation
Karolinska Institutet (Sweden)
Sponsor details
c/o Angelica Lindén Hirschberg
Department of Women's and Children's health
Stockholm
SE 171 76
Sweden
Sponsor type
Research organisation
Website
Funders
Funder type
Research council
Funder name
Vetenskapsrådet ref: 20324
Alternative name(s)
Swedish Research Council
Funding Body Type
unknown
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
IPD sharing statement
The datasets generated during and/or analysed during the current study are/will be available upon request from Angelica Lindén Hirschberg (angelica.linden-hirschberg@sll.se).
Intention to publish date
Participant level data
Available on request
Basic results (scientific)
Publication list
2019 results in https://www.ncbi.nlm.nih.gov/pubmed/30565716 (added 04/12/2019)