Treatment of PCOS (Polycystic Ovary Syndrome)in Morbidly Obese Women - A Randomized Controlled Prospective Dietary Intervention Study
19 Years
38 Years
Female
Polycystic Ovary Syndrome, Morbid Obesity
Trial Information
Treatment of PCOS (Polycystic Ovary Syndrome)in Morbidly Obese Women - A Randomized Controlled Prospective Dietary Intervention Study
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.
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Weight loss
Outcome Time Frame:
One year
Safety Issue:
No
Principal Investigator
Jøran Hjelmesæth, MD, PhD
Investigator Role:
Principal Investigator
Investigator Affiliation:
The Hospital of Vestfold
Authority:
Norway:National Committee for Medical and Health Research Ethics
Study ID:
86-814d 6.2008.453
NCT ID:
NCT00779571
Start Date:
October 2008
Completion Date:
February 2012
Related Keywords:
- Polycystic Ovary Syndrome
- Morbid Obesity
- Polycystic Ovary Syndrome
- Morbid Obesity
- Type 2 DM
- Coronary heart disease
- Obesity
- Obesity, Morbid
- Polycystic Ovary Syndrome
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