Morbid Obesity, Polycystic Ovary Syndrome
Conditions
Keywords
Polycystic Ovary Syndrome, Morbid Obesity, Type 2 DM, Coronary heart disease
Brief summary
This study has two phases: 1. In phase 1 of the study (8 weeks),the effect of two different low calorie diets on manifestations of PCOS, including risk factors for the metabolic syndrome and cardiovascular risk profile will be compared. 2. In phase 2 the long term effect (next 44 weeks) on sustained weight-loss and the above mentioned parameters will be compared and evaluated.
Detailed description
Weight loss is an important and effective treatment of morbidly obese women with PCOS. Effective weight reduction will improve manifestations of PCOS and risk factors for developing type 2 diabetes and coronary heart diseases. We compare the effect of two isocaloric low calorie diets (LCD), - one powder-based shake-diet and a fiber rich diet on the above mentioned parameters. In addition we want to compare the weight-maintenance effect the next 44 weeks of two different follow-up programs: A usual care- and a lifestyle-program.
Interventions
BEHAVIORALCrispbread
8 week low calorie diet
Sponsors
Oslo University Hospital
The Hospital of Vestfold
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
19 Years to 38 Years
Healthy volunteers
No
Inclusion criteria
* Woman (European Caucasian) * PCOS * BMI = or \> 35
Exclusion criteria
* Cushing syndrome * Adrenal hyperplasia * Androgen-producing tumors * Anovulation caused by hyperprolactinemia * Pregnancy, breast feeding * Use of oral contraceptives/hormone treatment/insulin-sensitizing agents
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Weight loss | One year |
Secondary
| Measure | Time frame |
|---|---|
| Improvement of PCOS, diabetes type 2- and coronary heart disease-risk factors | one year |
Countries
Norway
Outcome results
None listed