Hormonal and metabolic effects of diet and physical activity in women with polycystic ovary syndrome (PCOS)

Not Applicable

Completed

• Conditions: Polycystic ovary syndrome (PCOS); Pregnancy and Childbirth

• Registration Number: ISRCTN18400086
• Lead Sponsor: Karolinska Institutet

Brief Summary

1. 2014 results in: https://www.ncbi.nlm.nih.gov/pubmed/24842895 2. 2016 results in: https://www.ncbi.nlm.nih.gov/pubmed/26649621 3. 2017 results in: https://www.ncbi.nlm.nih.gov/pubmed/28388727 4. 2019 results in: https://www.ncbi.nlm.nih.gov/pubmed/31389293 (added 09/08/2019)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2012-12-31
• Study Start: 2018-02-05
• Last Update Posted: 2 September 2019

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 50

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Weight change is measured using the body weight at baseline and 12 weeks.

Secondary Outcome Measures

Name	Time	Method
<br> 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<br> 2. Insulin sensitivity of the endometrium is measured using determination of gene and protein levels of molecules involved in insulin signaling at baseline and 12 weeks<br> 3. Endometrial hormone receptor expression is measured using determination of gene and protein levels of hormone receptors at baseline and 12 weeks<br>