Obstructive Sleep ApneaNCT00273104

The Effect of Lifestyle Intervention Versus Gastric Bypass on Various Comorbidities in Morbidly Obese Subjects

A study testing Bariatric surgery and Intensive lifestyle intervention in people with Obstructive Sleep Apnea and Diabetes Mellitus, run by The Hospital of Vestfold at 1 site in Norway.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This follow up study (>1 year) aims to compare the effects of lifestyle intervention and gastric by pass surgery on various comorbidities associated with morbid obesity. Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Obstructive Sleep Apnea, Diabetes Mellitus, Hypertension
What is being tested?: Bariatric surgery and Intensive lifestyle intervention
Type of treatment: Surgery or procedure, Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 180 participants
Where: 1 siteNorway
Study dates: Dec 2005to Dec 2017
Phase: Interventional
Are there results?: None posted in the registry

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 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Morbidly obese patients

Who cannot join

Trial locations and contacts

1 site in 1 country.

Norway1 site

Hospital in Vestfold
Tønsberg, 3117

Other trials in Norway

About this study

Official title: The Effect of Lifestyle Intervention vs Gastric Bypass on Various Comorbidities

This follow up study (>1 year) aims to compare the effects of lifestyle intervention and gastric by pass surgery on various comorbidities associated with morbid obesity.

Read the detailed description

Not addressed

Conditions: Obstructive Sleep Apnea, Diabetes Mellitus, Hypertension
Being tested: Bariatric surgery, Intensive lifestyle intervention
Medical subject headings: Sleep Apnea, Obstructive, Diabetes Mellitus, Hypertension

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 as a part of public health service offered treatment seeking morbidly obese patients.
Intensive lifestyle interventionBehavioural
Intensive lifestyle intervention as a part of public health service offered treatment seeking morbidly obese patients.

Study groups in NCT00273104
Study group	Role	What they receive
Bariatric surgery	Active comparator	Bariatric surgery (gastric bypass) offered to patients after informed consent and shared decision. The surgical procedure was performed at Vestfold Hospital Trust by experienced bariatric surgeons. Receives: Procedure: Bariatric surgery
Intensive lifestyle intervention	Active comparator	Intensive lifestyle intervention (1-year endurance) at a rehabilitation centre. The intervention consisted of motivation for behaviour change including calorie restriction and increased physical activity. Receives: Behavioral: Intensive lifestyle intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

Improvement of co-morbidities
1-year comparative nonrandomized controlled trial
Measured: 1-year after treatment start

Secondary outcomes (1)

Safety issues
Surgical complications and serious adverse events in both groups as published
Measured: 1-year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Dec 2005Dec 2017

First posted9 Jan 2006 (estimated)
Study startDec 2005
Primary completionDec 2012
Study completionDec 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (8)Papers the sponsor has linked to this study.
Other trials for Obstructive Sleep ApneaStudies 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: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 180 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00273104
Sponsor's protocol ID: S-05175
Status last verified: Apr 2018
First submitted: 5 Jan 2006
Last updated: 19 Apr 2018
Results posted: No
Data monitoring committee: No

Publications

Gabrielsen AM, Omland T, Brokner M, Fredheim JM, Jordan J, Lehmann S, Lund MB, Hjelmesaeth J, Hofso D. The effect of surgical and non-surgical weight loss on N-terminal pro-B-type natriuretic peptide and its relation to obstructive sleep apnea and pulmonary function. BMC Res Notes. 2016 Sep 13;9(1):440. doi: 10.1186/s13104-016-2241-x.
PubMed 27619215
Hofso D, Birkeland KI, Holst JJ, Bollerslev J, Sandbu R, Roislien J, Hjelmesaeth J. Gastric bypass surgery has a weight-loss independent effect on post-challenge serum glucose levels. Diabetol Metab Syndr. 2015 Aug 22;7:69. doi: 10.1186/s13098-015-0066-8. eCollection 2015.
PubMed 26300987
Gabrielsen AM, Lund MB, Kongerud J, Viken KE, Roislien J, Hjelmesaeth J, Hofso D. Pulmonary function and blood gases after gastric bypass and lifestyle intervention: a comparative study. Clin Obes. 2013 Oct;3(5):117-23. doi: 10.1111/cob.12024. Epub 2013 Jul 8.
PubMed 25586626
Karlsen TI, Lund RS, Roislien J, Tonstad S, Natvig GK, Sandbu R, Hjelmesaeth J. Health related quality of life after gastric bypass or intensive lifestyle intervention: a controlled clinical study. Health Qual Life Outcomes. 2013 Feb 13;11:17. doi: 10.1186/1477-7525-11-17.
PubMed 23406190
Nordstrand N, Hertel JK, Hofso D, Sandbu R, Saltvedt E, Roislien J, Os I, Hjelmesaeth J. A controlled clinical trial of the effect of gastric bypass surgery and intensive lifestyle intervention on nocturnal hypertension and the circadian blood pressure rhythm in patients with morbid obesity. Surgery. 2012 May;151(5):674-80. doi: 10.1016/j.surg.2011.12.007. Epub 2012 Jan 18.
PubMed 22261295
Fredheim JM, Rollheim J, Omland T, Hofso D, Roislien J, Vegsgaard K, Hjelmesaeth J. Type 2 diabetes and pre-diabetes are associated with obstructive sleep apnea in extremely obese subjects: a cross-sectional study. Cardiovasc Diabetol. 2011 Sep 25;10:84. doi: 10.1186/1475-2840-10-84.
PubMed 21943153
Hofso D, Jenssen T, Bollerslev J, Ueland T, Godang K, Stumvoll M, Sandbu R, Roislien J, Hjelmesaeth J. Beta cell function after weight loss: a clinical trial comparing gastric bypass surgery and intensive lifestyle intervention. Eur J Endocrinol. 2011 Feb;164(2):231-8. doi: 10.1530/EJE-10-0804. Epub 2010 Nov 15.
PubMed 21078684
Hofso D, Nordstrand N, Johnson LK, Karlsen TI, Hager H, Jenssen T, Bollerslev J, Godang K, Sandbu R, Roislien J, Hjelmesaeth J. Obesity-related cardiovascular risk factors after weight loss: a clinical trial comparing gastric bypass surgery and intensive lifestyle intervention. Eur J Endocrinol. 2010 Nov;163(5):735-45. doi: 10.1530/EJE-10-0514. Epub 2010 Aug 26.
PubMed 20798226

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingObservational study
Development and Validation of a Multimodal Deep Learning Model Using Peripheral Oxygen Saturation and Ballistocardiography Signals for Predicting Apnea-Hypopnea Index in Obstructive Sleep Apnea
Obstructive Sleep Apnea
RecruitingPhase 3
A Study to Learn About the Monthly Dosing Study Medicine Called Berobenatide in Adults With Breathing Problems During Sleep and Overweight or Obesity Who Do Not Use a Breathing Machine (PAP) (VESPER-OSA 2)
Apnea, Sleep Disorders
Not yet recruitingPhase 2
Supplemental Oxygen for Sleep-Disordered Breathing in Adults With Chronic Opioid Use.
Sleep-disordered Breathing, Chronic Opioid Use
Recruiting
Nightly Wearable Monitoring During Home-Based Submental Electrical Stimulation for Obstructive Sleep Apnea
Obstructive Sleep Apnea
RecruitingPhase 1/2
DRonabinol Treatment of OSA
Obstructive Sleep Apnea

All Obstructive Sleep Apnea trials

Study at a glance

From the registry record, last updated by the sponsor on 19 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Effect of Lifestyle Intervention vs Gastric Bypass on Various Comorbidities
ClinicalTrials.gov ID: NCT00273104
Acronym / sponsor ID: S-05175
Conditions: Obstructive Sleep Apnea, Diabetes Mellitus, Hypertension
Study type: Interventional
Recruitment status: Completed
Enrolment: 180 participants (actual)
Lead sponsor: The Hospital of VestfoldUniversity, hospital or other
Collaborators: South-Eastern Norway Regional Health Authority
Study start: Dec 2005
Primary completion: Dec 2012 (actual)
Study completion: Dec 2017 (actual)
First posted: 9 Jan 2006 (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.

This follow up study (>1 year) aims to compare the effects of lifestyle intervention and gastric by pass surgery on various comorbidities associated with morbid obesity.

Detailed description

Not addressed

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Bariatric surgery	Active comparator	Procedure: Bariatric surgeryBariatric surgery (gastric bypass) offered to patients after informed consent and shared decision. The surgical procedure was performed at Vestfold Hospital Trust by experienced bariatric surgeons.
Intensive lifestyle intervention	Active comparator	Behavioral: Intensive lifestyle interventionIntensive lifestyle intervention (1-year endurance) at a rehabilitation centre. The intervention consisted of motivation for behaviour change including calorie restriction and increased physical activity.

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

Morbidly obese patients

Key exclusion criteria (1 listed)

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 as a part of public health service offered treatment seeking morbidly obese patients.	Procedure or surgery	Bariatric surgery
Intensive lifestyle interventionIntensive lifestyle intervention as a part of public health service offered treatment seeking morbidly obese patients.	Behavioural	Intensive lifestyle intervention

Primary outcome

Improvement of co-morbidities
Time frame: 1-year after treatment start
1-year comparative nonrandomized controlled trial

1 secondary outcome

Safety issues
Time frame: 1-year

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2018.
Derived from this study: PubMed 27619215Gabrielsen AM, Omland T, Brokner M, Fredheim JM, Jordan J, Lehmann S, Lund MB, Hjelmesaeth J, Hofso D. The effect of surgical and non-surgical weight loss on N-terminal pro-B-type natriuretic peptide and its relation to obstructive sleep apnea and pulmonary function. BMC Res Notes. 2016 Sep 13;9(1):440. doi: 10.1186/s13104-016-2241-x.
Derived from this study: PubMed 26300987Hofso D, Birkeland KI, Holst JJ, Bollerslev J, Sandbu R, Roislien J, Hjelmesaeth J. Gastric bypass surgery has a weight-loss independent effect on post-challenge serum glucose levels. Diabetol Metab Syndr. 2015 Aug 22;7:69. doi: 10.1186/s13098-015-0066-8. eCollection 2015.
Derived from this study: PubMed 25586626Gabrielsen AM, Lund MB, Kongerud J, Viken KE, Roislien J, Hjelmesaeth J, Hofso D. Pulmonary function and blood gases after gastric bypass and lifestyle intervention: a comparative study. Clin Obes. 2013 Oct;3(5):117-23. doi: 10.1111/cob.12024. Epub 2013 Jul 8.
Derived from this study: PubMed 23406190Karlsen TI, Lund RS, Roislien J, Tonstad S, Natvig GK, Sandbu R, Hjelmesaeth J. Health related quality of life after gastric bypass or intensive lifestyle intervention: a controlled clinical study. Health Qual Life Outcomes. 2013 Feb 13;11:17. doi: 10.1186/1477-7525-11-17.
Derived from this study: PubMed 22261295Nordstrand N, Hertel JK, Hofso D, Sandbu R, Saltvedt E, Roislien J, Os I, Hjelmesaeth J. A controlled clinical trial of the effect of gastric bypass surgery and intensive lifestyle intervention on nocturnal hypertension and the circadian blood pressure rhythm in patients with morbid obesity. Surgery. 2012 May;151(5):674-80. doi: 10.1016/j.surg.2011.12.007. Epub 2012 Jan 18.
Derived from this study: PubMed 21943153Fredheim JM, Rollheim J, Omland T, Hofso D, Roislien J, Vegsgaard K, Hjelmesaeth J. Type 2 diabetes and pre-diabetes are associated with obstructive sleep apnea in extremely obese subjects: a cross-sectional study. Cardiovasc Diabetol. 2011 Sep 25;10:84. doi: 10.1186/1475-2840-10-84.
Derived from this study: PubMed 21078684Hofso D, Jenssen T, Bollerslev J, Ueland T, Godang K, Stumvoll M, Sandbu R, Roislien J, Hjelmesaeth J. Beta cell function after weight loss: a clinical trial comparing gastric bypass surgery and intensive lifestyle intervention. Eur J Endocrinol. 2011 Feb;164(2):231-8. doi: 10.1530/EJE-10-0804. Epub 2010 Nov 15.
Derived from this study: PubMed 20798226Hofso D, Nordstrand N, Johnson LK, Karlsen TI, Hager H, Jenssen T, Bollerslev J, Godang K, Sandbu R, Roislien J, Hjelmesaeth J. Obesity-related cardiovascular risk factors after weight loss: a clinical trial comparing gastric bypass surgery and intensive lifestyle intervention. Eur J Endocrinol. 2010 Nov;163(5):735-45. doi: 10.1530/EJE-10-0514. Epub 2010 Aug 26.

Related trials for Obstructive Sleep Apnea

RecruitingObservational study
Development and Validation of a Multimodal Deep Learning Model Using Peripheral Oxygen Saturation and Ballistocardiography Signals for Predicting Apnea-Hypopnea Index in Obstructive Sleep Apnea
Obstructive Sleep Apnea
RecruitingPhase 3
A Study to Learn About the Monthly Dosing Study Medicine Called Berobenatide in Adults With Breathing Problems During Sleep and Overweight or Obesity Who Do Not Use a Breathing Machine (PAP) (VESPER-OSA 2)
Apnea, Sleep Disorders
Not yet recruitingPhase 2
Supplemental Oxygen for Sleep-Disordered Breathing in Adults With Chronic Opioid Use.
Sleep-disordered Breathing, Chronic Opioid Use
Recruiting
Nightly Wearable Monitoring During Home-Based Submental Electrical Stimulation for Obstructive Sleep Apnea
Obstructive Sleep Apnea
RecruitingPhase 1/2
DRonabinol Treatment of OSA
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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, MD PhD principal investigator

Hospital of Vestfold

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Bariatric surgery and Intensive lifestyle intervention in people with Obstructive Sleep Apnea and Diabetes Mellitus, 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: finished, as of the sponsor's last update on 19 Apr 2018. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Improvement of co-morbidities (time frame: 1-year after treatment start). 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 NCT00273104, which also lists 8 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 19 Apr 2018.