NCT00626964

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
7mo left

Started Feb 2008

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress97%
Feb 2008Dec 2026

Study Start

First participant enrolled

February 1, 2008

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

February 20, 2008

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 29, 2008

Completed
18.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

June 11, 2025

Status Verified

June 1, 2025

Enrollment Period

18.8 years

First QC Date

February 20, 2008

Last Update Submit

June 10, 2025

Conditions

Morbid ObesityHypertensionType 2 DMObstructive Sleep ApneaOsteoarthrosis

Keywords

Arterial stiffnessPulseWave velocityBody compositionBioimpedanceMorbid ObesityAPO AAPO BFramingham risk scorePrevention of Coronary Heart DiseaseLifestyle InterventionBariatric SurgeryLow Energy Diet

Outcome Measures

Primary Outcomes (2)

  • Arterial stiffness

    Pulse wave velocity and augmentation index

    7 weeks and 1 year

  • Cardiovascular risk factors

    Several biomarkers will be examined

    7 weeks and 1 year

Study Arms (1)

Lifestyle or bariatric surgery

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

Procedure: Bariatric SurgeryBehavioral: Conservative Treatment:

Interventions

Bariatric SurgeryPROCEDURE

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

Lifestyle or bariatric surgery
Conservative Treatment:BEHAVIORAL

Intensive Lifestyle Intervention Program

Also known as: Conservative
Lifestyle or bariatric surgery

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Morbidly Obese patients with BMI \> 40, or BMI \> 35 with comorbidity such as Hypertension, Obstructive Sleep Apnea, Weight Related Osteoarthrosis, Type 2 DM.

You may qualify if:

  • Morbidly Obese patients with BMI \> 40, or BMI \> 35 with comorbidity such as Hypertension, Obstructive Sleep Apnea, Weight Related Osteoarthrosis, Type 2 DM.

You may not qualify if:

  • Participation in other weight loss program the last 12 months. Serious psychiatric conditions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Morbid Obesity Center, Vestfold Hospital Trust

Tønsberg, 3115, Norway

Location

Related Publications (3)

  • 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.

    PMID: 37995847DERIVED

  • 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.

    PMID: 36577984DERIVED

  • 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.

    PMID: 21284837DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples to biobank.

MeSH Terms

Conditions

Obesity, MorbidHypertensionSleep Apnea, ObstructiveOsteoarthritis

Interventions

Bariatric SurgeryConservative Treatment

Condition Hierarchy (Ancestors)

ObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsVascular DiseasesCardiovascular DiseasesSleep Apnea SyndromesApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Intervention Hierarchy (Ancestors)

BariatricsObesity ManagementTherapeuticsSurgical Procedures, Operative

Study Officials

  • Jøran Hjelmesæth

    Morbid Obesity Center, Vestfold Hospital Trust

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

February 20, 2008

First Posted

February 29, 2008

Study Start

February 1, 2008

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

June 11, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

Locations

NO(1)