Back to resultsThe Effect of Lifestyle Intervention Versus Gastric Bypass on Various Comorbidities in Morbidly Obese Subjects
Primary Purpose
Obstructive Sleep Apnea, Diabetes Mellitus, Hypertension
Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Bariatric surgery
Intensive lifestyle intervention
Sponsored by
About this trial
This is an interventional treatment trial for Obstructive Sleep Apnea
Eligibility Criteria
Inclusion Criteria: Morbidly obese patients Exclusion Criteria: -
Sites / Locations
- Hospital in Vestfold
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Bariatric surgery
Intensive lifestyle intervention
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Improvement of co-morbidities
1-year comparative nonrandomized controlled trial
Secondary Outcome Measures
Safety issues
Surgical complications and serious adverse events in both groups as published
Full Information
NCT ID
NCT00273104
First Posted
January 5, 2006
Last Updated
April 18, 2018
Sponsor
The Hospital of Vestfold
Collaborators
South-Eastern Norway Regional Health Authority
1. Study Identification
Unique Protocol Identification Number
NCT00273104
Brief Title
The Effect of Lifestyle Intervention Versus Gastric Bypass on Various Comorbidities in Morbidly Obese Subjects
Official Title
The Effect of Lifestyle Intervention vs Gastric Bypass on Various Comorbidities
Study Type
Interventional
2. Study Status
Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
December 2005 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
December 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Hospital of Vestfold
Collaborators
South-Eastern Norway Regional Health Authority
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
Detailed Description
Not addressed
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Sleep Apnea, Diabetes Mellitus, Hypertension
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
180 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Bariatric surgery
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Intensive lifestyle intervention
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Bariatric surgery
Intervention Description
Bariatric surgery as a part of public health service offered treatment seeking morbidly obese patients.
Intervention Type
Behavioral
Intervention Name(s)
Intensive lifestyle intervention
Intervention Description
Intensive lifestyle intervention as a part of public health service offered treatment seeking morbidly obese patients.
Primary Outcome Measure Information:
Title
Improvement of co-morbidities
Description
1-year comparative nonrandomized controlled trial
Time Frame
1-year after treatment start
Secondary Outcome Measure Information:
Title
Safety issues
Description
Surgical complications and serious adverse events in both groups as published
Time Frame
1-year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Morbidly obese patients
Exclusion Criteria:
-
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jøran Hjelmesæth, MD PhD
Organizational Affiliation
Hospital of Vestfold
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital in Vestfold
City
Tonsberg
ZIP/Postal Code
3117
Country
Norway
12. IPD Sharing Statement
Citations:
PubMed Identifier
27619215
Citation
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.
Results Reference
derived
PubMed Identifier
26300987
Citation
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.
Results Reference
derived
PubMed Identifier
25586626
Citation
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.
Results Reference
derived
PubMed Identifier
23406190
Citation
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.
Results Reference
derived
PubMed Identifier
22261295
Citation
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.
Results Reference
derived
PubMed Identifier
21943153
Citation
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.
Results Reference
derived
PubMed Identifier
21078684
Citation
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.
Results Reference
derived
PubMed Identifier
20798226
Citation
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.
Results Reference
derived
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The Effect of Lifestyle Intervention Versus Gastric Bypass on Various Comorbidities in Morbidly Obese Subjects
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