The Effect of Lifestyle Intervention Versus Gastric Bypass on Various Comorbidities in Morbidly Obese Subjects
1 other identifier
interventional
180
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Dec 2005
Longer than P75 for not_applicable
1 active site
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 Start
First participant enrolled
December 1, 2005
CompletedFirst Submitted
Initial submission to the registry
January 5, 2006
CompletedFirst Posted
Study publicly available on registry
January 9, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2017
CompletedApril 19, 2018
April 1, 2018
7 years
January 5, 2006
April 18, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Improvement of co-morbidities
1-year comparative nonrandomized controlled trial
1-year after treatment start
Secondary Outcomes (1)
Safety issues
1-year
Study Arms (2)
Bariatric surgery
ACTIVE COMPARATORBariatric 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 COMPARATORIntensive lifestyle intervention (1-year endurance) at a rehabilitation centre. The intervention consisted of motivation for behaviour change including calorie restriction and increased physical activity.
Interventions
Bariatric surgery as a part of public health service offered treatment seeking morbidly obese patients.
Intensive lifestyle intervention as a part of public health service offered treatment seeking morbidly obese patients.
Eligibility Criteria
You may qualify if:
- Morbidly obese patients
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hospital in Vestfold
Tønsberg, 3117, Norway
Related Publications (8)
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.
PMID: 27619215DERIVEDHofso 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.
PMID: 26300987DERIVEDGabrielsen 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.
PMID: 25586626DERIVEDKarlsen 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.
PMID: 23406190DERIVEDNordstrand 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.
PMID: 22261295DERIVEDFredheim 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.
PMID: 21943153DERIVEDHofso 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.
PMID: 21078684DERIVEDHofso 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.
PMID: 20798226DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jøran Hjelmesæth, MD PhD
Hospital of Vestfold
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Head of Morbid Obesity Centre
Study Record Dates
First Submitted
January 5, 2006
First Posted
January 9, 2006
Study Start
December 1, 2005
Primary Completion
December 1, 2012
Study Completion
December 1, 2017
Last Updated
April 19, 2018
Record last verified: 2018-04