Prevention of Coronary Heart Disease in Morbidly Obese Patients

NCT ID: NCT00626964

Last Updated: 2025-06-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-02-29

Study Completion Date

2026-12-31

Brief Summary

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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

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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

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Morbid Obesity Hypertension Type 2 DM Obstructive Sleep Apnea Osteoarthrosis

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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Lifestyle or bariatric surgery

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

Bariatric Surgery

Intervention Type PROCEDURE

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

Conservative Treatment:

Intervention Type BEHAVIORAL

Intensive Lifestyle Intervention Program

Interventions

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Bariatric Surgery

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

Intervention Type PROCEDURE

Conservative Treatment:

Intensive Lifestyle Intervention Program

Intervention Type BEHAVIORAL

Other Intervention Names

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Conservative

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Oslo University Hospital

OTHER

Sponsor Role collaborator

The Hospital of Vestfold

OTHER

Sponsor Role lead

Responsible Party

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Jøran Hjelmesæth

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jøran Hjelmesæth

Role: PRINCIPAL_INVESTIGATOR

Morbid Obesity Center, Vestfold Hospital Trust

Locations

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Morbid Obesity Center, Vestfold Hospital Trust

Tønsberg, , Norway

Site Status

Countries

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Norway

References

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Young J, Seeberg KA, Aakre KM, Borgeraas H, Nordstrand N, Wisloff T, Hjelmesaeth J, Omland T, Hertel JK. The liver-heart axis in patients with severe obesity: The association between liver fibrosis and chronic myocardial injury may be explained by shared risk factors of cardiovascular disease. Clin Biochem. 2024 Jan;123:110688. doi: 10.1016/j.clinbiochem.2023.110688. Epub 2023 Nov 22.

Reference Type DERIVED
PMID: 37995847 (View on PubMed)

Berk KA, Borgeraas H, Narverud I, Mulder MT, Oyri LKL, Verhoeven AJM, Smastuen MC, Bogsrud MP, Omland T, Hertel JK, Gjevestad E, Nordstrand N, Holven KB, Hjelmesaeth J. Differential effects of bariatric surgery and lifestyle interventions on plasma levels of Lp(a) and fatty acids. Lipids Health Dis. 2022 Dec 28;21(1):145. doi: 10.1186/s12944-022-01756-1.

Reference Type DERIVED
PMID: 36577984 (View on PubMed)

Nordstrand N, Gjevestad E, Dinh KN, Hofso D, Roislien J, Saltvedt E, Os I, Hjelmesaeth J. The relationship between various measures of obesity and arterial stiffness in morbidly obese patients. BMC Cardiovasc Disord. 2011 Feb 1;11:7. doi: 10.1186/1471-2261-11-7.

Reference Type DERIVED
PMID: 21284837 (View on PubMed)

Other Identifiers

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S-0517

Identifier Type: -

Identifier Source: org_study_id

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