Prevention of Coronary Heart Disease in Morbidly Obese Patients (SphCor)
The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2008 by The Hospital of Vestfold.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
The Hospital of Vestfold
Collaborator:
Oslo University Hospital
Information provided by:
The Hospital of Vestfold
ClinicalTrials.gov Identifier:
NCT00626964
First received: February 20, 2008
Last updated: February 28, 2008
Last verified: February 2008
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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: | Time Perspective: Prospective |
| Official Title: | Prevention of Coronary Heart Disease in Morbidly Obese Patients. Lifestyle Intervention, Low Energy Diet or Bariatric Surgery. |
Resource links provided by NLM:
MedlinePlus related topics:
Coronary Artery Disease
Heart Diseases
High Blood Pressure
Obesity
Sleep Apnea
Weight Control
Weight Loss Surgery
U.S. FDA Resources
Further study details as provided by The Hospital of Vestfold:
Primary Outcome Measures:
- Arterial stiffness will decrease in the group with most weight loss [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples With DNA
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.
Other Name: Bariatric Surgery
Behavioral: Conservative Treatment:
Conservative Treatment: Intensive Lifestyle Intervention Program
Other Name: Conservative
|
Detailed Description:
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 |
Study Population
Morbidly Obese patients with BMI > 40, or BMI > 35 with comorbidity such as Hypertension, Obstructive Sleep Apnea, Weight Related Osteoarthrosis, Type 2 DM.
Criteria
Inclusion Criteria:
- Morbidly Obese patients with BMI > 40, or BMI > 35 with comorbidity such as Hypertension, Obstructive Sleep Apnea, Weight Related Osteoarthrosis, Type 2 DM.
Exclusion Criteria:
- Participation in other weight loss program the last 12 months. Serious psychiatric conditions
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00626964
Contacts
| 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 |
Locations
| 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 | |
Sponsors and Collaborators
The Hospital of Vestfold
Oslo University Hospital
Investigators
| Principal Investigator: | Khiem N-Dinh, MD | Center for Morbid Obesity, Vestfold Trust Hospital |
More Information
No publications provided by The Hospital of Vestfold
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Jøran Hjelmesæth, The Hospital of Vestfold |
| ClinicalTrials.gov Identifier: | NCT00626964 History of Changes |
| Other Study ID Numbers: | S-0517 |
| Study First Received: | February 20, 2008 |
| Last Updated: | February 28, 2008 |
| Health Authority: | Norway:National Committee for Medical and Health Research Ethics |
Keywords provided by The Hospital of Vestfold:
|
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 |
Additional relevant MeSH terms:
|
Coronary Artery Disease Myocardial Ischemia Coronary Disease Heart Diseases Hypertension Joint Diseases Osteoarthritis Obesity Obesity, Morbid Sleep Apnea Syndromes Sleep Apnea, Obstructive Cardiovascular Diseases Arteriosclerosis Arterial Occlusive Diseases Vascular Diseases |
Musculoskeletal Diseases Arthritis Rheumatic Diseases Overnutrition Nutrition Disorders Overweight Body Weight Signs and Symptoms Apnea Respiration Disorders Respiratory Tract Diseases Sleep Disorders, Intrinsic Dyssomnias Sleep Disorders Nervous System Diseases |
ClinicalTrials.gov processed this record on May 19, 2013