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Trial record 13 of 317 for:    PCOS
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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
History of Changes
  Purpose

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.


Condition Intervention
Polycystic Ovary Syndrome
 Other: Weight reduction regimen

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: To Estimate the Prevalence of PCOS in Obese Premenopausal Women and Elucidate How They Respond to a Weight Reduction Treatment Program

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Göteborg University:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 500
Study Start Date: March 2011
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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
 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 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
 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.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01319162

Contacts
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

Locations
Sweden
Sahlgrenska Obesity Center at Sahlgrenska University hospital Recruiting
Göteborg, Sweden, 41345
Contact: Elisabet Stener-Victorin, Associate professor     +46 31 7863557     elisabet.stener-victorin@neuro.gu.se    
Contact: Ingrid Larsson, PhD     +46 31 342000     ingrid.larsson@medfak.gu.se    
Principal Investigator: Elisabet Stener-Victorin, Associate professor, PhD            
Sub-Investigator: Ingrid Larsson, PhD            
Sponsors and Collaborators
Göteborg University
  More Information

No publications provided

Responsible Party: Göteborg University
ClinicalTrials.gov Identifier: NCT01319162     History of Changes
Other Study ID Numbers: Prevalence-PCOS-Obesity
Study First Received: March 18, 2011
Last Updated: April 5, 2013
Health Authority: Sweden: Regionala etikprövningsnämnden

Keywords provided by Göteborg University:
PCOS

Additional relevant MeSH terms:
Polycystic Ovary Syndrome
Ovarian Cysts
Cysts
Neoplasms
Ovarian Diseases
 Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders
Endocrine System Diseases

ClinicalTrials.gov processed this record on May 19, 2013