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| Name | Class |
|---|---|
| Oslo University Hospital | OTHER |
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The changes in risks of developing coronary heart disease in patients with morbid obesity after different weight loss interventions have not been extensively studied. The primary objective of this study is to investigate whether an intensive lifestyle intervention program in a tertiary care clinic (Spesialsykehuset for Rehabilitering) is comparable with a 7-week low-energy-diet followed by bariatric surgery in decreasing the risk of cardiovascular disease in these patients.
Patients matching the eligibility criteria were divided into two groups (not randomized). One group underwent a 7 weeks Low-Energy-Diet before bariatric surgery, the other group participated in an intensive lifestyle intervention program for 3 months.
Data on arterial stiffness, body weight, body composition, blood pressure, blood samples, vital parameters are registered in the both groups at baseline, 7 weeks and after 1 year.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lifestyle or bariatric surgery | Morbid Obesity with BMI >= 40 kg/m2 or BMI >= 35 with Comorbidity |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bariatric Surgery | Procedure | Bariatric Surgery Treatment: Duodenal Switch, Gastric Sleeve or Gastric bypass. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Arterial stiffness | Pulse wave velocity and augmentation index | 7 weeks and 1 year |
| Cardiovascular risk factors | Several biomarkers will be examined | 7 weeks and 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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Morbidly Obese patients with BMI > 40, or BMI > 35 with comorbidity such as Hypertension, Obstructive Sleep Apnea, Weight Related Osteoarthrosis, Type 2 DM.
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| Name | Affiliation | Role |
|---|---|---|
| Jøran Hjelmesæth | Morbid Obesity Center, Vestfold Hospital Trust | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Morbid Obesity Center, Vestfold Hospital Trust | Tønsberg | 3115 | Norway |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37995847 | Derived | Young J, Seeberg KA, Aakre KM, Borgeraas H, Nordstrand N, Wisloff T, Hjelmesaeth J, Omland T, Hertel JK. The liver-heart axis in patients with severe obesity: The association between liver fibrosis and chronic myocardial injury may be explained by shared risk factors of cardiovascular disease. Clin Biochem. 2024 Jan;123:110688. doi: 10.1016/j.clinbiochem.2023.110688. Epub 2023 Nov 22. | |
| 36577984 |
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| ID | Term |
|---|---|
| D009767 | Obesity, Morbid |
| D006973 | Hypertension |
| D020181 | Sleep Apnea, Obstructive |
| D010003 | Osteoarthritis |
| ID | Term |
|---|---|
| D009765 | Obesity |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
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| ID | Term |
|---|---|
| D050110 | Bariatric Surgery |
| D000072700 | Conservative Treatment |
| ID | Term |
|---|---|
| D049088 | Bariatrics |
| D000073319 | Obesity Management |
| D013812 | Therapeutics |
| D013514 | Surgical Procedures, Operative |
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Blood samples to biobank.
| Conservative Treatment: | Behavioral | Intensive Lifestyle Intervention Program |
|
|
| Derived |
| Berk KA, Borgeraas H, Narverud I, Mulder MT, Oyri LKL, Verhoeven AJM, Smastuen MC, Bogsrud MP, Omland T, Hertel JK, Gjevestad E, Nordstrand N, Holven KB, Hjelmesaeth J. Differential effects of bariatric surgery and lifestyle interventions on plasma levels of Lp(a) and fatty acids. Lipids Health Dis. 2022 Dec 28;21(1):145. doi: 10.1186/s12944-022-01756-1. |
| 21284837 | Derived | Nordstrand N, Gjevestad E, Dinh KN, Hofso D, Roislien J, Saltvedt E, Os I, Hjelmesaeth J. The relationship between various measures of obesity and arterial stiffness in morbidly obese patients. BMC Cardiovasc Disord. 2011 Feb 1;11:7. doi: 10.1186/1471-2261-11-7. |
| D009750 |
| Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D012891 | Sleep Apnea Syndromes |
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |