NCT00626964

Prevention of Coronary Heart Disease in Morbidly Obese Patients

Prevention of Coronary Heart Disease in Morbidly Obese Patients. Lifestyle Intervention, Low Energy Diet or Bariatric Surgery.

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 200 (actual)
• Sponsor: The Hospital of Vestfold · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

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.

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.

Conditions

• Morbid Obesity
• Hypertension
• Type 2 DM
• Obstructive Sleep Apnea
• Osteoarthrosis

Interventions

Type	Name	Description
PROCEDURE	Bariatric Surgery	Bariatric Surgery Treatment: Duodenal Switch, Gastric Sleeve or Gastric bypass.
BEHAVIORAL	Conservative Treatment:	Intensive Lifestyle Intervention Program

Timeline

• Start date: 2008-02-01
• Primary completion: 2026-12-01
• Completion: 2026-12-01
• First posted: 2008-02-29
• Last updated: 2025-06-11

Locations

1 site across 1 country: Norway