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

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00626964
First Posted: February 29, 2008
Last Update Posted: May 12, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Oslo University Hospital
Information provided by (Responsible Party):
Jøran Hjelmesæth, The Hospital of Vestfold
  Purpose
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.

Condition Intervention
Morbid Obesity Hypertension Type 2 DM Obstructive Sleep Apnea Osteoarthrosis Procedure: Bariatric Surgery Behavioral: Conservative Treatment:

Study Type: Observational
Study Design: Observational Model: Other
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 Jøran Hjelmesæth, The Hospital of Vestfold:

Primary Outcome Measures:
  • Arterial stiffness [ Time Frame: 7 weeks and 1 year ]
    Pulse wave velocity and augmentation index

  • Cardiovascular risk factors [ Time Frame: 7 weeks and 1 year ]
    Several biomarkers will be examined


Biospecimen Retention:   Samples With DNA
Blood samples to biobank.

Enrollment: 200
Study Start Date: February 2008
Estimated Study Completion Date: December 2020
Estimated Primary Completion Date: December 2020 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Lifestyle or bariatric surgery
Morbid Obesity with BMI >= 40 kg/m2 or BMI >= 35 with Comorbidity
Procedure: Bariatric Surgery
Bariatric Surgery Treatment: Duodenal Switch, Gastric Sleeve or Gastric bypass.
Behavioral: Conservative Treatment:
Intensive Lifestyle Intervention Program
Other Name: Conservative

Detailed Description:

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.

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


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.
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00626964


Locations
Norway
Morbid Obesity Center, Vestfold Hospital Trust
Tønsberg, Norway, 3115
Sponsors and Collaborators
The Hospital of Vestfold
Oslo University Hospital
Investigators
Principal Investigator: Jøran Hjelmesæth Morbid Obesity Center, Vestfold Hospital Trust
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Jøran Hjelmesæth, Professor, The Hospital of Vestfold
ClinicalTrials.gov Identifier: NCT00626964     History of Changes
Other Study ID Numbers: S-0517
First Submitted: February 20, 2008
First Posted: February 29, 2008
Last Update Posted: May 12, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Jøran Hjelmesæth, The Hospital of Vestfold:
Arterial stiffness
PulseWave velocity
Body composition
Bioimpedance
Morbid Obesity
APO A
APO B
Framingham risk score
Prevention of Coronary Heart Disease
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
Osteoarthritis
Cardiovascular Diseases
Sleep Apnea Syndromes
Apnea
Respiration Disorders
Respiratory Tract Diseases
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Vascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases