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| Name | Class |
|---|---|
| Oslo University Hospital | OTHER |
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This study has two phases:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Crispbread | Experimental | Intervention: Crispbread LCD |
|
| Liquid meal replacement | Active Comparator | Intervention: LMR LCD |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Crispbread | Behavioral | 8 week low calorie diet |
|
| Measure | Description | Time Frame |
|---|---|---|
| Weight loss | One year |
| Measure | Description | Time Frame |
|---|---|---|
| Improvement of PCOS, diabetes type 2- and coronary heart disease-risk factors | one year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jøran Hjelmesæth, MD, PhD | The Hospital of Vestfold | Principal Investigator |
| Tom Tanbo, MD, PhD | Oslo University Hospital | Study Chair |
| Kirsten B Holven, PhD | University of Oslo | Principal Investigator |
| Line Kristin Johnson, MSc | Oslo University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kvinneklinikken, Rikshospitalet-Radiumhospitalet HF | Oslo | Oslo | Norway |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26138702 | Derived | Johnson LK, Holven KB, Nordstrand N, Mellembakken JR, Tanbo T, Hjelmesaeth J. Fructose content of low calorie diets: effect on cardiometabolic risk factors in obese women with polycystic ovarian syndrome: a randomized controlled trial. Endocr Connect. 2015 Sep;4(3):144-54. doi: 10.1530/EC-15-0047. |
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| ID | Term |
|---|---|
| D011085 | Polycystic Ovary Syndrome |
| D009767 | Obesity, Morbid |
| D003327 | Coronary Disease |
| ID | Term |
|---|---|
| D010048 | Ovarian Cysts |
| D003560 | Cysts |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 |
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| Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D006058 | Gonadal Disorders |
| D004700 | Endocrine System Diseases |
| D009765 | Obesity |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |