Hormonal and metabolic effects of diet and physical activity in women with polycystic ovary syndrome (PCOS)
| ISRCTN | ISRCTN18400086 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN18400086 |
| Protocol serial number | Dnr 2008/865-32 |
| Sponsor | Karolinska Institutet |
| Funders | Swedish Research Council, Cancerfonden, Karolinska Institutet |
- Submission date
- 29/01/2018
- Registration date
- 05/02/2018
- Last edited
- 09/08/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Pregnancy and Childbirth
Plain English summary of protocol
Background and study aims
Polycystic ovary syndrome (PCOS) is the most condition that affects the ovaries. Its main characteristics are hyperandrogenism (high levels of male horomones), chronic anovulation (not ovulating) and polycystic ovaries (ovaries covered with cysts). Obesity and hyperinsulinemia (high levels of insulin) are also highly prevalent among women with PCOS. These issues can negatively affect endometrial function (the lining of the uterus). Impaired endometrial function is leading to implantation failure and endometrial abnormalities, such as hyperplasia (the enlargement of organs) and cancer. The aim of this study is to investigate whether weight loss and improved menstrual function can affect the expression of hormonal receptors that are of important for endometrial function in women with PCOS.
Who can participate?
Women aged 18-40 years old who have PCOS.
What does the study involve?
Participants are allocated to groups based on their weight. Participants are provided with individualized diet plans that are high in protein and low in carbohydrates. It is dietician supervised. Participants who are overweight are provided with a membership to a local exercise facility. Recommendations regarding the type, duration and frequency of training were individualized on the basis of interest, experience and present condition, with a weekly average of 2 or 3 45-min sessions of aerobic activity and verification by the staff of the gym. Participants are assessed before the intervention and on days 6-8, 21-24 of their menstruation cycle. Blood samples are taken from participants and analyzed. Endometrial biopsies are taken and transvaginal ultrasounds are done. Participants record their menstrual bleedin in a diary.
What are the possible benefits and risks of participating?
All patients participating in the study undergo general health check as well as gynecological examination. Taking part in the lifestyle intevention can result in improvement of general health. The risks of participating in the study are judged to be small. Endometrial biopsy and blood sampling are clinical routine examinations and rarely cause greater discomfort or complications. The overall risk is judged to be small in relation to the benefit of participating in the study.
Where is the study run from?
1. Swedish Research Council (Sweden)
2. Swedish Cancer Society (Sweden)
3. Karolinska Institutet (Sweden)
When is the study starting and how long is it expected to run for?
January 2008 to December 2012
Who is funding the study?
1. Swedish Research Council (Sweden)
2. The Swedish Cancer Society (Sweden)
3. Karolinska Institutet (Sweden)
4. Regional agreement on medical training and clinical research (ALF) between Stockholm County Council and Karolinska Institutet (ALH, LS) (Sweden)
Who is the main contact?
Prof Angelica Lindén Hirschberg (Scientific)
angelica.linden-hirschberg@sll.se
Contact information
Scientific
Department of Women's and Children's Health
Karolinska Institutet
Stockholm
17176
Sweden
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Prospective lifestyle intervention study |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | Hormonal and metabolic effects of diet and physical activity in women with polycystic ovary syndrome (PCOS) - a lifestyle intervention study |
| Study objectives | Lifestyle intervention aiming at weight loss could improve reproductive and metabolic health including endometrial function in overweight/obese women with PCOS. |
| Ethics approval(s) | Regional Ethics Committee Stockholm, 2008/06/18, ref: Dnr 2008/865-32 |
| Health condition(s) or problem(s) studied | Polycystic ovary syndrome (PCOS) |
| Intervention | The three-month individualized intervention involved changes in lifestyle designed to achieve weight loss. The diet was high in protein with little carbohydrate (40E% carbohydrates, 30E% fat and 30E% proteins). The dietician supervised and recommended the participants to intake three major meals and two or three snacks daily. Each participant reported her food intake, which was adjusted if necessary. In order to increase physical activity, all overweight women with PCOS are provided with membership in a local exercise facility (Friskis & Svettis). Recommendations regarding the type, duration and frequency of training were individualized on the basis of interest, experience and present condition, with a weekly average of 2 or 3 45-min sessions of aerobic activity and verification by the staff of the gym. The group of overweight/obese women with PCOS are examined before and immediately after the intervention, on days 6-8 and 21-23 of the menstrual cycle (assessed on the basis of spontaneous menstruation or bleeding induced by administration of 10 mg medroxyprogesterone acetate daily for 7 days). The women of normal weight with PCOS and all controls are examined once on days 6-8 and 21-23 of the same menstrual cycle. While still fasting, a blood sample was taken from a peripheral vein at the same time each morning. Serum collected by centrifugation was stored at -70° C for later analyses. All gynecological examinations, including transvaginal ultrasound, are performed with the Sonoline SL-250 apparatus (Siemens Healthcare Diagnostics) by a single investigator. Under local anesthesia, endometrial biopsies were taken with a suction curette (Pipet Curet, CooperSurgical, USA). During the intervention, the women in the OB-PCOS group recorded their menstrual bleedings in a diary and their ovulation are monitored (serum progesterone > 17 nmol/l). Alteration from amenorrhea to oligomenorrhea/regular menstruation or from oligomenorrhea to regular menstruation was defined as improvement. |
| Intervention type | Behavioural |
| Primary outcome measure(s) |
Weight change is measured using the body weight at baseline and 12 weeks. |
| Key secondary outcome measure(s) |
1. Menstrual function is evaluated using recordings of menstrual pattern and blood sampling of hormones during the intervention. The menstrual function is considered to be improved from baseline to 12 weeks when there is a shift from amenorrhea to oligomenorrhea/regular menstruation or from oligomenorrhea to regular menstruation and/or ovulation is confirmed by increased serum progesterone >17 nmol/L |
| Completion date | 31/12/2012 |
Eligibility
| Participant type(s) | Mixed |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 40 Years |
| Sex | Female |
| Target sample size at registration | 50 |
| Key inclusion criteria | 1. All Rotterdam criteria for the diagnosis of PCOS should be met (anovulation, hyperandrogenism, polycystic ovaries) 2. 18-40 years 3. BMI >27 4. No medication or hormone-containing contraceptives for 3 months before beginning the study 5. Willing to sign informed consent Healthy controls: Women with normal weight with PCOS |
| Key exclusion criteria | 1. Pregnancy or lactation during preceding 12 months 2. Smoking 3. Use of hormone-containing contraceptives 4. Current disease 5. Regular medication including insulin-sentizing drugs 6. Eating disorder |
| Date of first enrolment | 01/07/2008 |
| Date of final enrolment | 31/12/2011 |
Locations
Countries of recruitment
- Sweden
Study participating centre
171 76
Sweden
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Available on request |
| IPD sharing plan | 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 |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/07/2014 | Yes | No | |
| Results article | results | 01/02/2016 | Yes | No | |
| Results article | results | 01/04/2017 | Yes | No | |
| Results article | results | 01/03/2020 | 09/08/2019 | Yes | No |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
09/08/2019: Publication reference added.
