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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
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00626964
Acronym
SphCor
Enrollment
200
Registered
2008-02-29
Start date
2008-02-29
Completion date
2026-12-31
Last updated
2025-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

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

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.

Interventions

PROCEDUREBariatric Surgery

Bariatric Surgery Treatment: Duodenal Switch, Gastric Sleeve or Gastric bypass.

BEHAVIORALConservative Treatment:

Intensive Lifestyle Intervention Program

Sponsors

Oslo University Hospital
CollaboratorOTHER
The Hospital of Vestfold
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Arterial stiffness7 weeks and 1 yearPulse wave velocity and augmentation index
Cardiovascular risk factors7 weeks and 1 yearSeveral biomarkers will be examined

Countries

Norway

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 29, 2026