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

The Hospital of Vestfold

Status: Active, not recruiting

Conditions: Hypertension; Type 2 DM; Morbid Obesity; Osteoarthrosis; Obstructive Sleep Apnea

Treatments: Behavioral: Conservative Treatment:; Procedure: Bariatric Surgery

Study type: Observational

Funder types: Other

Identifiers

NCT00626964

S-0517

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

200 participants in 1 patient group

Lifestyle or bariatric surgery

Description:

Morbid Obesity with BMI \>= 40 kg/m2 or BMI \>= 35 with Comorbidity

Treatment:

Procedure: Bariatric Surgery

Behavioral: Conservative Treatment: