Condition category
Nutritional, Metabolic, Endocrine
Date applied
02/05/2011
Date assigned
01/06/2011
Last edited
17/03/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Angelica Hirschberg

ORCID ID

Contact details

Department of Women's and Children's Health
Karolinska Institute
Stockholm
SE-171 76
Sweden

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Hormonal and metabolic effects of diet and exercise programs in obese women with polycystic ovary syndrome : a prospective randomised controlled trial

Acronym

Study hypothesis

Combined treatment with diet and exercise is superior than diet and exercise alone to improve reproductive function in women with polycystic ovary syndrome (PCOS)

Ethics approval

CI Research Ethics Committee at Karolinska Hospital North (KI forskningsetikkommitté Nord vid Karolinska sjukhuset), 29/08/2002, No 02-243

Study design

Prospective randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Polycystic ovary syndrome (PCOS)

Intervention

The interventions lasted for four months, with monthly visits and follow-up was continued for more than one year after termination of the programs.

The diets were designed individually under the close supervision of a dietician. It was recommended that total daily caloric intake be reduced by at least 600 kcal/d in comparison to before the intervention, while maintaining a well-balanced diet containing 55-60% carbohydrates, 25-30% fat (10% saturated) and 10-15% proteins, according to Swedish nutritional recommendations (SNO) in 2005. A strict schedule of three main meals and two or three snacks was also introduced. Food intake was assessed by self-reporting once every 24 hours during the 4 days both immediately before and at the end of intervention.

The exercise program was supervised by a physiotherapist and was designed to enhance both the type and level of physical activity to a level conforming to each individual patient´s capacity, goals and interest at the beginning of this intervention. Physical activity was assessed utilising pedometers (Yamax SW-200 Tokyo, Japan) during the four days immediately before and at the end of the program.

During both types of intervention monthly follow-ups with the dietician and/or physiotherapist were scheduled for discussion of the goals achieved, as well as setting up new goals for the next month.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Immediately before this study, after four months of intervention and at the time of the long-term follow-up, each patient underwent a general health control involving determination of blood pressure, weight, height and waist/hip ratio (WHR).

1. All gynecological examinations including transvaginal ultrasound using Sonoline SI-250 equipment (Siemens Healthcare Diagnostics, Deerfield, IL, USA) were performed by the same investigator. The ovarian parameters evaluated were the maximal number of follicles in one plane and the volumes of the largest follicle and of the entire ovary. Menstrual bleedings were recorded and ovulation confirmed on the basis of an elevation in the serum level of progesterone during the luteal phase of the menstrual cycle.
2. For determination of body composition, the patients were examined by dual energy X-ray absorptiometry (DXA) employing a Lunar Prodigy Advance whole body scanner (GE medical systems, Fairfield, CT, USA).

Secondary outcome measures

Improved insulin sensitivity - In a resting and fasting state at 8:00 am a blood sample was collected from a peripheral vein and the serum separated by centrifugation and stored at – 70 degree celsius, pending analysis for hormones, binding proteins and glucose.

Evaluated immediately before this study, after four months of intervention and at the time of the long-term follow-up

Overall trial start date

01/01/2003

Overall trial end date

31/12/2009

Reason abandoned

Eligibility

Participant inclusion criteria

Women aged 18-40 years diagnosed with PCOS and having body mass index (BMI) > 27

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

45

Participant exclusion criteria

1. The presence of other disease or a different endocrine disorder
2. An eating disorder
3. Smoking
4. Continuous medication including insulin sensitising drugs

Recruitment start date

01/01/2003

Recruitment end date

31/12/2009

Locations

Countries of recruitment

Sweden

Trial participating centre

Department of Women's and Children's Health
Stockholm
SE-171 76
Sweden

Sponsor information

Organisation

Karolinska Institute (Sweden)

Sponsor details

Department of Women's and Children's Health
c/o Angelica Hirschberg
Stockholm
SE-171 76
Sweden

Sponsor type

University/education

Website

Funders

Funder type

Research council

Funder name

The Swedish Research Council (Sweden)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/23876536

Publication citations

  1. Results

    Nybacka Å, Carlström K, Fabri F, Hellström PM, Hirschberg AL, Serum antimüllerian hormone in response to dietary management and/or physical exercise in overweight/obese women with polycystic ovary syndrome: secondary analysis of a randomized controlled trial., Fertil. Steril., 2013, 100, 4, 1096-1102, doi: 10.1016/j.fertnstert.2013.06.030.

Additional files

Editorial Notes