Morbid ObesitySphCorNCT00626964
Prevention of Coronary Heart Disease in Morbidly Obese Patients
An observational study of Morbid Obesity and Hypertension, run by The Hospital of Vestfold at 1 site in Norway.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Morbid Obesity, Hypertension, Type 2 DM
- What is being tested?
- Bariatric Surgery and Conservative Treatment:
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- How many people
- 200 participants
- Where
- 1 siteNorway
- Study dates
- Feb 2008to Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Morbidly Obese patients with BMI > 40, or BMI > 35 with comorbidity such as Hypertension, Obstructive Sleep Apnea, Weight Related Osteoarthrosis, Type 2 DM.
Who cannot join
- Participation in other weight loss program the last 12 months. Serious psychiatric conditions
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prevention of Coronary Heart Disease in Morbidly Obese Patients. Lifestyle Intervention, Low Energy Diet or Bariatric Surgery.
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.
Read the 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
- Being tested
- Bariatric Surgery, Conservative Treatment:
- 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
- Medical subject headings
- Obesity, Morbid, Hypertension, Sleep Apnea, Obstructive, Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bariatric SurgeryProcedure or surgery
Bariatric Surgery Treatment: Duodenal Switch, Gastric Sleeve or Gastric bypass.
Conservative Treatment:Behavioural
Also called Conservative
Intensive Lifestyle Intervention Program
| Study group | Role | What they receive |
|---|---|---|
| Lifestyle or bariatric surgery | Morbid Obesity with BMI >= 40 kg/m2 or BMI >= 35 with Comorbidity Receives: Procedure: Bariatric Surgery; Behavioral: Conservative Treatment: |
What is being measured
The primary outcome is the main question the study is designed to answer.
Arterial stiffness
Pulse wave velocity and augmentation index
Measured: 7 weeks and 1 year
Cardiovascular risk factors
Several biomarkers will be examined
Measured: 7 weeks and 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Feb 2008 (estimated)
- Study startFeb 2008
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Morbid ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hospital of Vestfold
- Sponsor type
- University, hospital or other
- Collaborators
- Oslo University Hospital
- Responsible party
- Principal investigator, Jøran Hjelmesæth, The Hospital of Vestfold
- Investigators
- Jøran Hjelmesæth, Principal investigator, Morbid Obesity Center, Vestfold Hospital Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00626964
- Sponsor's protocol ID
- S-0517
- Acronym
- SphCor
- Status last verified
- Jun 2025
- First submitted
- 20 Feb 2008
- Last updated
- 11 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 37995847Berk 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.
PubMed 36577984Nordstrand 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.
PubMed 21284837
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of Coronary Heart Disease in Morbidly Obese Patients. Lifestyle Intervention, Low Energy Diet or Bariatric Surgery.
- ClinicalTrials.gov ID
- NCT00626964
- Acronym / sponsor ID
- SphCor / S-0517
- Conditions
- Morbid Obesity, Hypertension, Type 2 DM, Obstructive Sleep Apnea, Osteoarthrosis
- Keywords
- Arterial stiffness, PulseWave velocity, Body composition, Bioimpedance, Morbid Obesity, APO A, APO B, Framingham risk score
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 200 participants (actual)
- Lead sponsor
- The Hospital of VestfoldUniversity, hospital or other
- Collaborators
- Oslo University Hospital
- Study start
- Feb 2008
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 29 Feb 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lifestyle or bariatric surgery | – | Procedure: Bariatric Surgery, Behavioral: Conservative Treatment:Morbid Obesity with BMI >= 40 kg/m2 or BMI >= 35 with Comorbidity |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- Morbidly Obese patients with BMI > 40, or BMI > 35 with comorbidity such as Hypertension, Obstructive Sleep Apnea, Weight Related Osteoarthrosis, Type 2 DM.
Key exclusion criteria (1 listed)
- Participation in other weight loss program the last 12 months. Serious psychiatric conditions
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bariatric SurgeryBariatric Surgery Treatment: Duodenal Switch, Gastric Sleeve or Gastric bypass. | Procedure or surgery | Lifestyle or bariatric surgery |
| Conservative Treatment:Also: ConservativeIntensive Lifestyle Intervention Program | Behavioural | Lifestyle or bariatric surgery |
Primary outcome
Arterial stiffness
Time frame: 7 weeks and 1 year
Pulse wave velocity and augmentation index
Cardiovascular risk factors
Time frame: 7 weeks and 1 year
Several biomarkers will be examined
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2025.
- Derived from this study: PubMed 37995847Young 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.
- Derived from this study: PubMed 36577984Berk 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.
- Derived from this study: PubMed 21284837Nordstrand 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jøran Hjelmesæth principal investigator
Morbid Obesity Center, Vestfold Hospital Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Morbid Obesity and Hypertension, run by The Hospital of Vestfold at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 11 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Arterial stiffness (time frame: 7 weeks and 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00626964, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2025.