Obstructive Sleep Apnea, Predictors and Bariatric Surgery
NCT ID: NCT03223467
Last Updated: 2020-07-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
86 participants
INTERVENTIONAL
2012-01-04
2017-12-30
Brief Summary
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Obesity, male sex and age are all risk factors for obstructive sleep apnea (Schwartz. et al. 2010, Edwards. et al. 2010) . Bariatric surgery is known to be a good treatment to achieve a sustained weight loss but the long term effects of bariatric treatment of obstructive sleep apnea is not well studied. The aim of this study is therefore to study the long effects of bariatric surgery as a treatment for obstructive sleep apnea and to find predictors that can be used to predict the severity of the disease.
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Detailed Description
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Obesity, male sex and age are all risk factors for obstructive sleep apnea (Schwartz et. al. 2010, Edwards. et. al. 2010) . Bariatric surgery is known to be a good treatment to achieve a sustained weight loss but the long term effects of bariatric treatment of obstructive sleep apnea is not well studied. The aim of this study is therefore to study the long effects of bariatric surgery as a treatment for obstructive sleep apnea and to find predictors that can be used to predict the severity of the disease.
Eighty-six patients with obesity have been recruited at the Catholic University hospital in Rome, Italy during 2012 when patients were enrolled during their evaluation for bariatric surgery. At baseline, the patient underwent fasting blood chemistry, anthropometric measurements and overnight polysomnography. The patients also underwent a 3 hour oral glucose tolerance test in order to determinate glucose tolerance (normal glucose tolerance, impaired glucose tolerance and type 2 diabetes mellitus). Patient then received treatment with bariatric surgery (gastric sleeve, biliopancreatic diversion or gastric bypass) during 2012-2013 or decided not to undergo bariatric surgery.
Patient will undergo follow-up during 2016-2017 where fasting blood chemistry, anthropometric measurements and overnight polysomnography will be assessed. The patient will also undergo a 3 hour oral glucose tolerance test.
The effects of bariatric surgery on obstructive sleep apnea will then be evaluated. Differences in the treatment effect between the different bariatric surgical procedures will be studied. Patients characteristics at baseline, such as weight, height, BMI and components of the metabolic syndrome and their association to the severity of obstructive sleep apnea will be studied in order to find predictors for the severity of the disease.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Biliopancreatic diversion
Study participants will undergo biliopancreatic diversion which is a type of bariatric surgery where a part of the stomach are removed and the remaining stomach is attached to a distal segment of the small intestine.
Bariatric surgery
Bariatric surgery includes several different types of surgical procedures used to achieve weight loss.
Gastric sleeve
Study participants will undergo sleeve gastrectomy which is a restrictive form av bariatric surgery where the size of the stomach is reduced.
Bariatric surgery
Bariatric surgery includes several different types of surgical procedures used to achieve weight loss.
Gastric bypass
Study participants will undergo gastric bypass which is a type of bariatric surgery where a small pouch of the stomach is created and attached to a segment of the small intestine.
Bariatric surgery
Bariatric surgery includes several different types of surgical procedures used to achieve weight loss.
No intervention
Study participants that do not want to undergo surgical treatment.
No interventions assigned to this group
Interventions
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Bariatric surgery
Bariatric surgery includes several different types of surgical procedures used to achieve weight loss.
Eligibility Criteria
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Inclusion Criteria
* Age between 20 and 70 years
* Willingness to understand the protocol and willingness to participate in the study
Exclusion Criteria
20 Years
70 Years
ALL
No
Sponsors
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Catholic University of the Sacred Heart
OTHER
Responsible Party
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Geltrude Mingrone
Professor
Principal Investigators
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Geltrude Mingrone, MD. PhD.
Role: PRINCIPAL_INVESTIGATOR
The Catholic University of the Sacred Heart
References
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Malhotra A, White DP. Obstructive sleep apnoea. Lancet. 2002 Jul 20;360(9328):237-45. doi: 10.1016/S0140-6736(02)09464-3.
Ensrud KE, Blackwell TL, Ancoli-Israel S, Redline S, Cawthon PM, Paudel ML, Dam TT, Stone KL. Sleep disturbances and risk of frailty and mortality in older men. Sleep Med. 2012 Dec;13(10):1217-25. doi: 10.1016/j.sleep.2012.04.010. Epub 2012 Jun 15.
Kuhn E, Schwarz EI, Bratton DJ, Rossi VA, Kohler M. Effects of CPAP and Mandibular Advancement Devices on Health-Related Quality of Life in OSA: A Systematic Review and Meta-analysis. Chest. 2017 Apr;151(4):786-794. doi: 10.1016/j.chest.2017.01.020. Epub 2017 Jan 24.
Schwartz AR, Patil SP, Squier S, Schneider H, Kirkness JP, Smith PL. Obesity and upper airway control during sleep. J Appl Physiol (1985). 2010 Feb;108(2):430-5. doi: 10.1152/japplphysiol.00919.2009. Epub 2009 Oct 29.
Edwards BA, O'Driscoll DM, Ali A, Jordan AS, Trinder J, Malhotra A. Aging and sleep: physiology and pathophysiology. Semin Respir Crit Care Med. 2010 Oct;31(5):618-33. doi: 10.1055/s-0030-1265902. Epub 2010 Oct 12.
Other Identifiers
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OSA2012
Identifier Type: -
Identifier Source: org_study_id
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