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| Sponsors and Collaborators: |
The Hospital of Vestfold Rikshospitalet HF |
|---|---|
| Information provided by: | The Hospital of Vestfold |
| ClinicalTrials.gov Identifier: | NCT00626964 |
Purpose
The changes in risks of developing coronary heart disease in morbidly obese patients after different weight loss interventions have not been extensively studied. The objective of this study is to investigate whether an intensive lifestyle intervention program in a tertiary care clinic (Spesialsykehuset for Rehabilitering) is comparable with bariatric surgery in decreasing the risk of cardiovascular disease in these patients.
| Condition | Intervention |
|---|---|
|
Morbid Obesity Hypertension Type 2 DM Obstructive Sleep Apnea Osteoarthrosis |
Procedure: Bariatric Surgery Behavioral: Conservative Treatment: |
| Study Type: | Observational |
| Study Design: | Prospective |
| Official Title: | Prevention of Coronary Heart Disease in Morbidly Obese Patients. Lifestyle Intervention, Low Energy Diet or Bariatric Surgery. |
Blood samples to biobank.
| Estimated Enrollment: | 200 |
| Study Start Date: | February 2008 |
| Estimated Study Completion Date: | January 2011 |
| Estimated Primary Completion Date: | January 2011 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
1
Morbidly Obesity with BMI > 40 kg/m2 or BMI > 35 with Comorbidity such as Hypertension, Type 2 Diabetes, Weight Related Osteoarthrosis, Obstructive Sleep Apnea
|
Procedure: Bariatric Surgery
Bariatric Surgery Treatment: Duodenal Switch, Gastric Sleeve or Gastric bypass.
Behavioral: Conservative Treatment:
Conservative Treatment: Intensive Lifestyle Intervention Program
|
Patients matching the eligibility criteria are divided into two groups (not randomized). One group will undergo 8 weeks preparation with Low Energy Diet before bariatric surgery, the other group will participate in an intensive lifestyle intervention program for 3 months.
Data on arterial stiffness, weight, body composition,blood samples, vital parameters are registered in the both groups at baseline, 7 weeks and after 1 year.
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Morbidly Obese patients with BMI > 40, or BMI > 35 with comorbidity such as Hypertension, Obstructive Sleep Apnea, Weight Related Osteoarthrosis, Type 2 DM.
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Jøran Hjelmeseth, Ph D | 33342000 ext + 47 | joran.hjelmeseth@siv.no |
| Contact: Khiem N-Dinh, MD | 33342000 ext + 47 | Khiem.N-Dinh@siv.no |
| Norway | |
| Hospital of Vestfold | Recruiting |
| Tønsberg, Norway, 3115 | |
| Contact: Jøran Hjelmeseth, Ph D 33342000 ext + 47 joran.hjelmeseth@siv.no | |
| Contact: Khiem N-Dinh, MD 33342000 ext + 47 Khiem.N-Dinh@siv.no | |
| Principal Investigator: | Khiem N-Dinh, MD | Center for Morbid Obesity, Vestfold Trust Hospital |
More Information
| Responsible Party: | The Hospital of Vestfold ( Jøran Hjelmesæth ) |
| Study ID Numbers: | S-0517 |
| Study First Received: | February 20, 2008 |
| Last Updated: | February 28, 2008 |
| ClinicalTrials.gov Identifier: | NCT00626964 |
| Health Authority: | Norway: The National Committees for Research Ethics in Norway |
|
Arterial stiffness PulseWave velocity Body composition Inbody Morbidly Obese APO A APO B |
Framingham risk score Prevention of Coronary Heart Disease Morbidly Obese Patients Lifestyle Intervention Bariatric Surgery Low Energy Diet |
|
Osteoarthritis Myocardial Ischemia Sleep Apnea, Obstructive Sleep Disorders Overweight Arteriosclerosis Sleep Disorders, Intrinsic Body Weight Signs and Symptoms Respiratory Tract Diseases Musculoskeletal Diseases Arthritis Nutrition Disorders Arterial Occlusive Diseases Obesity |
Sleep Apnea Syndromes Heart Diseases Apnea Joint Diseases Respiration Disorders Vascular Diseases Dyssomnias Obesity, Morbid Ischemia Rheumatic Diseases Coronary Disease Overnutrition Coronary Artery Disease Hypertension |
|
Nervous System Diseases Cardiovascular Diseases |
