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
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
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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.