Prevalence of Polycystic Ovary Syndrome (PCOS) in Obese Premenopausal Women

This study is currently recruiting participants.
Verified April 2013 by Göteborg University
Sponsor:
Information provided by (Responsible Party):
Göteborg University
ClinicalTrials.gov Identifier:
NCT01319162
First received: March 18, 2011
Last updated: April 5, 2013
Last verified: April 2013

March 18, 2011
April 5, 2013
March 2011
December 2013   (final data collection date for primary outcome measure)
Prevalence/probability of PCOS among obese, premenopausal women (between 18 and 50 years) with no symptoms of classic menopausal symptoms in Sweden. [ Time Frame: Within one month after first visit ] [ Designated as safety issue: No ]
Screening for PCOS among obese women includes menstrual history, clinical and biochemical signs of hyperandrogenism and polycystic ovaries on ultrasound measure in women with one of signs included in the diagnosis of the syndrome.
Same as current
Complete list of historical versions of study NCT01319162 on ClinicalTrials.gov Archive Site
  • Response to weight reduction regime among obese women with and without PCOS [ Time Frame: One year after inclusion ] [ Designated as safety issue: No ]
  • Food frequency [ Time Frame: Within one month after measure ] [ Designated as safety issue: No ]
  • Health Related Quality of Life [ Time Frame: Screening and one year later ] [ Designated as safety issue: No ]
  • Symptoms of anxiety and depression [ Time Frame: Screening and after one year ] [ Designated as safety issue: No ]
  • Changes in sex steroids and other related hormones [ Time Frame: Screening and after 1 year ] [ Designated as safety issue: No ]
  • Response to weight reduction regim among obese women with and without PCOS [ Time Frame: One year after inclusion ] [ Designated as safety issue: No ]
  • Food frequency [ Time Frame: Within one month after measure ] [ Designated as safety issue: No ]
  • Health Related Quality of Life [ Time Frame: Screening and one year later ] [ Designated as safety issue: No ]
  • Symptoms of anxiety and depression [ Time Frame: Screening and after one year ] [ Designated as safety issue: No ]
  • Changes in sex steroids and other related hormones [ Time Frame: Screening and after 1 year ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Prevalence of Polycystic Ovary Syndrome (PCOS) in Obese Premenopausal Women
To Estimate the Prevalence of PCOS in Obese Premenopausal Women and Elucidate How They Respond to a Weight Reduction Treatment Program

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.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
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Probability Sample

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.

Polycystic Ovary Syndrome
Other: Weight reduction regimen
The dietary intervention begins with a 12-weeks VLCD/LCD period. The diet comprise of 3 to 5 portions liquid diet with a daily energy intake of 450-800 kcal. In addition, patients will be encouraged to drink 1,5-2L daily of non-caloric beverages (<6 kcal/100 ml). All patients will have scheduled nurse visits at week 0 (baseline), 2, 5, 8, and 12. At these visits general well-being and body weight will be monitored. The patient will also be given support and counselling to enhance compliance to the VLCD/LCD diet.
  • Women with PCOS
    All obese women between 18 and 50 years diagnosed with PCOS referred to a weight reduction treatment program at the Sahlgrenska Obesity Center at Sahlgrenska University hospital
    Intervention: Other: Weight reduction regimen
  • Women without PCOS
    All obese women between 18 and 50 years not diagnosed with PCOS referred to a weight reduction treatment program at the Sahlgrenska Obesity Center at Sahlgrenska University hospital
    Intervention: Other: Weight reduction regimen
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
500
June 2014
December 2013   (final data collection date for primary outcome measure)

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.
Female
18 Years to 50 Years
Yes
Contact: Elisabet Stener-Victorin, Associate professor, PhD +46 31 7863557 elisabet.stener-victorin@neuro.gu.se
Contact: Ingrid Larsson, PhD +46313420000 ingrid.larsson@medfak.gu.se
Sweden
 
NCT01319162
Prevalence-PCOS-Obesity
No
Göteborg University
Göteborg University
Not Provided
Not Provided
Göteborg University
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP