Clinical trial NCT01319162: Prevalence of Polycystic Ovary Syndrome (PCOS) in Obese Premenopausal Women
Official title: To Estimate the Prevalence of PCOS in Obese Premenopausal Women and Elucidate How They Respond to a Weight Reduction Treatment Program
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Polycystic Ovary Syndrome
Keywords: PCOS
Lead sponsor: Göteborg University
Sponsor class: OTHER
First posted: 2011-03-21
Enrollment: 300
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All obese women between 18 and 50 years referred to a weight reduction treatment program at the Sahlgrenska Obesity Center at Sahlgrenska University hospital will, after oral and written informed consent, be screened for the diagnosis of PCOS according to NIH or Rotterdam diagnostic criteria depending on the availability of ultrasonography.

Brief summary: Between 40% and 85% of women with Polycystic Ovary Syndrome (PCOS) are overweight or obese and obesity is closely linked to the development of PCOS. Although it is well established that obesity increases the severity of the clinical features of PCOS, data regarding the prevalence of PCOS in obese women and the change in body weight in women with PCOS over time are scares. In a prevalence study it was investigated whether obesity increases the risk of PCOS in the general population and they demonstrated that the prevalence rate of PCOS in underweight, normal-weight, overweight, and obese women were 8.2, 9.8, 9.9, and 9.0%, respectively, similar to that observed in the general population. These results suggest that the risk of PCOS is only minimally increased with obesity. On the other hand, in a Spanish prevalence study among overweight and obese subjects, they demonstrated a 28.3% prevalence of PCOS, which is markedly higher compared with the 5.5% prevalence of PCOS in lean women in Spain.

First the investigators aim to estimate the prevalence/probability of PCOS among obese, premenopausal women (between 18 and 50 years) with no symptoms of classic menopausal symptoms in Sweden. Secondly, to elucidate whether women diagnosed with PCOS respond to standard weight reduction regime to the same extent as women without PCOS.


Eligibility criteria: Inclusion Criteria:

PCOS diagnostic criteria should be the presence of both clinical and/or biochemical hyperandrogenism and/or oligo-/amenorrhea and/or polycystic ovaries (PCO).

Exclusion Criteria:

1. Exclusion of other endocrine disorders such as hyperprolactinemia (s-prolactin \< 27µg/L), nonclassic congenital adrenal hyperplasia (17-hydroxyprogesterone \< 3nmol/L), and androgen secreting tumors.
2. Pregnancy or breastfeeding the last 6 months.
3. Any sign of climacteric symptoms.
4. Language barrier or disabled person with reduced ability to understand information.
5. Oral contraceptives and insulin sensitizing agents is commonly used among women with PCOS since it may interfere with hormone profile. As the prevalence of PCOS can be assumed to be increased among women using oral contraceptives and insulin sensitizing agents, they are included but analyzed separately.

Primary outcomes:
measure: Prevalence/probability of PCOS among obese, premenopausal women (between 18 and 50 years) with no symptoms of classic menopausal symptoms in Sweden.
timeFrame: Within one month after first visit
Secondary outcomes:
measure: Response to weight reduction regime among obese women with and without PCOS
timeFrame: One year after inclusion
measure: Food frequency
timeFrame: Within one month after measure
measure: Health Related Quality of Life
timeFrame: Screening and one year later
measure: Symptoms of anxiety and depression
timeFrame: Screening and after one year
measure: Changes in sex steroids and other related hormones
timeFrame: Screening and after 1 year
Other outcomes:
Locations:
city: Göteborg
country: Sweden
facility: Sahlgrenska Obesity Center at Sahlgrenska University hospital
Study officials:
References:
citation: Kataoka J, Larsson I, Lindgren E, Kindstrand LO, Schmidt J, Stener-Victorin E. Circulating Anti-Mullerian hormone in a cohort-study of women with severe obesity with and without polycystic ovary syndrome and the effect of a one-year weight loss intervention. Reprod Biol Endocrinol. 2022 Oct 29;20(1):153. doi: 10.1186/s12958-022-01022-0.
citation: Kataoka J, Larsson I, Bjorkman S, Eliasson B, Schmidt J, Stener-Victorin E. Prevalence of polycystic ovary syndrome in women with severe obesity - Effects of a structured weight loss programme. Clin Endocrinol (Oxf). 2019 Dec;91(6):750-758. doi: 10.1111/cen.14098. Epub 2019 Oct 1.