NCT01319162

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2011

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 18, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 21, 2011

Completed
9 days until next milestone

Study Start

First participant enrolled

March 30, 2011

Completed
5.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 11, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 11, 2017

Completed
Last Updated

March 16, 2017

Status Verified

March 1, 2017

Enrollment Period

5.8 years

First QC Date

March 18, 2011

Last Update Submit

March 15, 2017

Conditions

Polycystic Ovary Syndrome

Keywords

PCOS

Outcome Measures

Primary Outcomes (1)

  • Prevalence/probability of PCOS among obese, premenopausal women (between 18 and 50 years) with no symptoms of classic menopausal symptoms in Sweden.

    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 Outcomes (5)

  • Response to weight reduction regime among obese women with and without PCOS

    One year after inclusion

  • Food frequency

    Within one month after measure

  • Health Related Quality of Life

    Screening and one year later

  • Symptoms of anxiety and depression

    Screening and after one year

  • Changes in sex steroids and other related hormones

    Screening and after 1 year

Study Arms (2)

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

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

Interventions

Weight reduction regimenOTHER

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 PCOSWomen without PCOS

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability 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.

You may qualify if:

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

You may not qualify if:

  • Pregnancy or breastfeeding the last 6 months.
  • Any sign of climacteric symptoms.
  • Language barrier or disabled person with reduced ability to understand information.
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sahlgrenska Obesity Center at Sahlgrenska University hospital

Gothenburg, 41345, Sweden

Location

Related Publications (4)

  • Kataoka J, Olsson M, Lindgren E, Larsson I, Schmidt J, Benrick A, Stener-Victorin E. Effects of weight loss intervention on anxiety, depression and quality of life in women with severe obesity and polycystic ovary syndrome. Sci Rep. 2024 Jun 12;14(1):13495. doi: 10.1038/s41598-024-63166-w.

    PMID: 38866860DERIVED

  • Kataoka J, Stener-Victorin E, Schmidt J, Larsson I. A prospective 12-month structured weight loss intervention in women with severe obesity and polycystic ovary syndrome: Impact of weight loss on eating behaviors. Acta Obstet Gynecol Scand. 2024 Aug;103(8):1615-1624. doi: 10.1111/aogs.14867. Epub 2024 May 8.

    PMID: 38717931DERIVED

  • 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.

    PMID: 36309748DERIVED

  • 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.

    PMID: 31529511DERIVED

MeSH Terms

Conditions

Polycystic Ovary Syndrome

Condition Hierarchy (Ancestors)

Ovarian CystsCystsNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesGonadal DisordersEndocrine System Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 18, 2011

First Posted

March 21, 2011

Study Start

March 30, 2011

Primary Completion

January 11, 2017

Study Completion

January 11, 2017

Last Updated

March 16, 2017

Record last verified: 2017-03

Locations

SE(1)