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
Sponsor:
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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
Bariatric Surgery
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
Low Energy Diet

Additional relevant MeSH terms:
Hypertension
Heart Diseases
Sleep Apnea, Obstructive
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Obesity, Morbid
Joint Diseases
Osteoarthritis
Vascular Diseases
Cardiovascular Diseases
Sleep Apnea Syndromes
Apnea
Respiration Disorders
Respiratory Tract Diseases
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Musculoskeletal Diseases
Arthritis
Rheumatic Diseases

ClinicalTrials.gov processed this record on October 19, 2014