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Prevention of Coronary Heart Disease in Morbidly Obese Patients (SphCor)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified February 2008 by The Hospital of Vestfold.
Recruitment status was:  Recruiting
Oslo University Hospital
Information provided by:
The Hospital of Vestfold Identifier:
First received: February 20, 2008
Last updated: February 28, 2008
Last verified: February 2008
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
Type 2 DM
Obstructive Sleep Apnea
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:

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 ]

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
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
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.


Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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.

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
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Please refer to this study by its identifier: NCT00626964

Hospital of Vestfold
Tønsberg, Norway, 3115
Sponsors and Collaborators
The Hospital of Vestfold
Oslo University Hospital
Principal Investigator: Khiem N-Dinh, MD Center for Morbid Obesity, Vestfold Trust Hospital
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Jøran Hjelmesæth, The Hospital of Vestfold Identifier: NCT00626964     History of Changes
Other Study ID Numbers: S-0517 
Study First Received: February 20, 2008
Last Updated: February 28, 2008

Keywords provided by The Hospital of Vestfold:
Arterial stiffness
PulseWave velocity
Body composition
Morbidly Obese
Framingham risk score
Prevention of Coronary Heart Disease
Morbidly Obese Patients
Lifestyle Intervention
Bariatric Surgery
Low Energy Diet

Additional relevant MeSH terms:
Heart Diseases
Sleep Apnea, Obstructive
Coronary Disease
Coronary Artery Disease
Myocardial Ischemia
Obesity, Morbid
Joint Diseases
Cardiovascular Diseases
Sleep Apnea Syndromes
Respiration Disorders
Respiratory Tract Diseases
Sleep Disorders, Intrinsic
Sleep Wake Disorders
Nervous System Diseases
Vascular Diseases
Arterial Occlusive Diseases
Nutrition Disorders
Body Weight
Signs and Symptoms
Musculoskeletal Diseases
Rheumatic Diseases processed this record on February 20, 2017