Prevention of Coronary Heart Disease in Morbidly Obese Patients

Active, not recruiting

• Conditions: Hypertension; Morbid Obesity; Type 2 DM; Obstructive Sleep Apnea; Osteoarthrosis
• Interventions: Procedure: Bariatric Surgery

• Registration Number: NCT00626964
• Lead Sponsor: The Hospital of Vestfold

Brief 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.

Study Timeline

• Study Start: 2008-02
• Study First Submitted: 2008-02-20
• Study First Submitted QC: 2008-02-28
• Study First Posted: 2008-02-29
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-18
• Last Update Posted: 2024-03-19
• Primary Completion: 2026-12
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Lifestyle or bariatric surgery	Bariatric Surgery	Morbid Obesity with BMI \>= 40 kg/m2 or BMI \>= 35 with Comorbidity

Primary Outcome Measures

Name	Time	Method
Arterial stiffness	7 weeks and 1 year	Pulse wave velocity and augmentation index
Cardiovascular risk factors	7 weeks and 1 year	Several biomarkers will be examined

Trial Locations

Locations (1)

Morbid Obesity Center, Vestfold Hospital Trust; 🇳🇴 Tønsberg, Norway