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

March 15, 2017 updated by: Göteborg University

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Göteborg, Sweden, 41345
        • Sahlgrenska Obesity Center at Sahlgrenska University hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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.
Within one month after first visit

Secondary Outcome Measures

Outcome Measure
Time Frame
Response to weight reduction regime among obese women with and without PCOS
Time Frame: One year after inclusion
One year after inclusion
Food frequency
Time Frame: Within one month after measure
Within one month after measure
Health Related Quality of Life
Time Frame: Screening and one year later
Screening and one year later
Symptoms of anxiety and depression
Time Frame: Screening and after one year
Screening and after one year
Changes in sex steroids and other related hormones
Time Frame: Screening and after 1 year
Screening and after 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Göteborg University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 30, 2011

Primary Completion (Actual)

January 11, 2017

Study Completion (Actual)

January 11, 2017

Study Registration Dates

First Submitted

March 18, 2011

First Submitted That Met QC Criteria

March 18, 2011

First Posted (Estimate)

March 21, 2011

Study Record Updates

Last Update Posted (Actual)

March 16, 2017

Last Update Submitted That Met QC Criteria

March 15, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Prevalence-PCOS-Obesity

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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