Hormonal and metabolic effects of diet and exercise programs in obese women with polycystic ovary syndrome (Hormonella och metabola effekter av diet- och motionsprogram hos överviktiga kvinnor med polycystiskt ovariesyndrom)

ISRCTN	ISRCTN48342048
DOI	https://doi.org/10.1186/ISRCTN48342048
Secondary identifying numbers	N/A

Submission date: 02/05/2011
Registration date: 01/06/2011
Last edited: 17/03/2014

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Nutritional, Metabolic, Endocrine

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Angelica Hirschberg
Scientific

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

Study information

Study design	Prospective randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	Hormonal and metabolic effects of diet and exercise programs in obese women with polycystic ovary syndrome : a prospective randomised controlled trial
Study objectives	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(s)	CI Research Ethics Committee at Karolinska Hospital North (KI forskningsetikkommitté Nord vid Karolinska sjukhuset), 29/08/2002, No 02-243
Health condition(s) or problem(s) studied	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
Primary outcome measure	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 study start date	01/01/2003
Completion date	31/12/2009

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Upper age limit	40 Years
Sex	Female
Target number of participants	45
Key inclusion criteria	Women aged 18-40 years diagnosed with PCOS and having body mass index (BMI) > 27
Key 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
Date of first enrolment	01/01/2003
Date of final enrolment	31/12/2009

Locations

Countries of recruitment

Sweden

Study participating centre

Department of Women's and Children's Health

Stockholm
SE-171 76
Sweden

Sponsor information

Karolinska Institute (Sweden)
University/education

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

"ROR"	https://ror.org/056d84691

Funders

Funder type

Research council

The Swedish Research Council (Sweden)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/10/2013		Yes	No