Changes in Body Composition Following Bariatric Surgery
NCT ID: NCT02148068
Last Updated: 2018-11-20
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
136 participants
OBSERVATIONAL
2014-05-31
2018-10-31
Brief Summary
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Detailed Description
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* All patients will undergo a bariatric surgery. The decision to undergo weight loss surgery and the operation chosen will both occur independent of and prior to enrollment in the study. The University of Iowa is a Bariatric Center of Excellence with three active, board-certified bariatric surgeons.
* Serial BodPod examinations will be performed on each patient. The BodPod is a commercially available device produced by Cosmed. It uses whole-body densitometry to determine body composition. To do this, it takes small changes in the volume of air in the BodPod chamber and records the associated changes in pressure. The pressure change typically goes unnoticed and is equivalent to the change in pressure while moving from the first floor to the second floor in an elevator. The entire process takes approximately five minutes with two minutes spent within the machine. The computer will then use mathematical formulas to calculate various body composition values.
* Laboratory analysis - There is a battery of labs that are ordered in both the pre-operative and post-operative time frame. These labs are ordered independent of the patient's participation in the study. These labs are ordered to assist in the management of the patient's medical comorbidities and to assess for adequate nutritional intake. These labs will also be recorded in the research database to assist in quantifying the degree of resolution of medical comorbidities.
* Queries on nutritional intake and exercise will be made at each post-operative appointment. The intake of protein is an important variable and may influence maintenance of lean tissue mass. Exercise is an important component of the post-bariatric weight loss program. This also will influence the changes in lean tissue mass.
Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Bariatric Surgery - Gastric Bypass
This population will undergo a laparoscopic roux-en-y gastric bypass
Bariatric Surgery
Patients enrolled will undergo either a laparoscopic Roux-en-y Gastric Bypass or laparoscopic Sleeve Gastrectomy. The determination of which operation performed will be made independent of patients' enrollment in the study.
Bariatric Surgery - Sleeve Gastrectomy
This group will undergo a laparoscopic sleeve gastrectomy
Bariatric Surgery
Patients enrolled will undergo either a laparoscopic Roux-en-y Gastric Bypass or laparoscopic Sleeve Gastrectomy. The determination of which operation performed will be made independent of patients' enrollment in the study.
Interventions
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Bariatric Surgery
Patients enrolled will undergo either a laparoscopic Roux-en-y Gastric Bypass or laparoscopic Sleeve Gastrectomy. The determination of which operation performed will be made independent of patients' enrollment in the study.
Eligibility Criteria
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Inclusion Criteria
* Individuals must have voluntarily initiated a surgical consultation for weight loss surgery
* Individuals must have completed a medical supervised weight loss program
Exclusion Criteria
* Those who are or become pregnant
* Individuals with severe claustrophobia.
18 Years
65 Years
ALL
Yes
Sponsors
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Peter Nau
OTHER
Responsible Party
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Peter Nau
Clinical Assistant Professor
Principal Investigators
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Peter N Nau, MD, MS
Role: PRINCIPAL_INVESTIGATOR
University of Iowa
Locations
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University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States
Countries
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References
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Hu FB. Resolved: there is sufficient scientific evidence that decreasing sugar-sweetened beverage consumption will reduce the prevalence of obesity and obesity-related diseases. Obes Rev. 2013 Aug;14(8):606-19. doi: 10.1111/obr.12040. Epub 2013 Jun 13.
Popkin BM, Adair LS, Ng SW. Global nutrition transition and the pandemic of obesity in developing countries. Nutr Rev. 2012 Jan;70(1):3-21. doi: 10.1111/j.1753-4887.2011.00456.x.
Kautiainen S, Rimpela A, Vikat A, Virtanen SM. Secular trends in overweight and obesity among Finnish adolescents in 1977-1999. Int J Obes Relat Metab Disord. 2002 Apr;26(4):544-52. doi: 10.1038/sj.ijo.0801928.
Heude B, Lafay L, Borys JM, Thibult N, Lommez A, Romon M, Ducimetiere P, Charles MA. Time trend in height, weight, and obesity prevalence in school children from Northern France, 1992-2000. Diabetes Metab. 2003 Jun;29(3):235-40. doi: 10.1016/s1262-3636(07)70032-0.
Jackson-Leach R, Lobstein T. Estimated burden of paediatric obesity and co-morbidities in Europe. Part 1. The increase in the prevalence of child obesity in Europe is itself increasing. Int J Pediatr Obes. 2006;1(1):26-32. doi: 10.1080/17477160600586614.
Schauer PR, Kashyap SR, Wolski K, Brethauer SA, Kirwan JP, Pothier CE, Thomas S, Abood B, Nissen SE, Bhatt DL. Bariatric surgery versus intensive medical therapy in obese patients with diabetes. N Engl J Med. 2012 Apr 26;366(17):1567-76. doi: 10.1056/NEJMoa1200225. Epub 2012 Mar 26.
Sjostrom L, Lindroos AK, Peltonen M, Torgerson J, Bouchard C, Carlsson B, Dahlgren S, Larsson B, Narbro K, Sjostrom CD, Sullivan M, Wedel H; Swedish Obese Subjects Study Scientific Group. Lifestyle, diabetes, and cardiovascular risk factors 10 years after bariatric surgery. N Engl J Med. 2004 Dec 23;351(26):2683-93. doi: 10.1056/NEJMoa035622.
Himpens J, Cadiere GB, Bazi M, Vouche M, Cadiere B, Dapri G. Long-term outcomes of laparoscopic adjustable gastric banding. Arch Surg. 2011 Jul;146(7):802-7. doi: 10.1001/archsurg.2011.45. Epub 2011 Mar 21.
Jackson TD, Hutter MM. Morbidity and effectiveness of laparoscopic sleeve gastrectomy, adjustable gastric band, and gastric bypass for morbid obesity. Adv Surg. 2012;46:255-68. doi: 10.1016/j.yasu.2012.05.002.
Moize V, Andreu A, Rodriguez L, Flores L, Ibarzabal A, Lacy A, Jimenez A, Vidal J. Protein intake and lean tissue mass retention following bariatric surgery. Clin Nutr. 2013 Aug;32(4):550-5. doi: 10.1016/j.clnu.2012.11.007. Epub 2012 Nov 14.
Chaston TB, Dixon JB, O'Brien PE. Changes in fat-free mass during significant weight loss: a systematic review. Int J Obes (Lond). 2007 May;31(5):743-50. doi: 10.1038/sj.ijo.0803483. Epub 2006 Oct 31.
Tsai S. Importance of lean body mass in the oncologic patient. Nutr Clin Pract. 2012 Oct;27(5):593-8. doi: 10.1177/0884533612457949. Epub 2012 Aug 16.
Guillet C, Masgrau A, Walrand S, Boirie Y. Impaired protein metabolism: interlinks between obesity, insulin resistance and inflammation. Obes Rev. 2012 Dec;13 Suppl 2:51-7. doi: 10.1111/j.1467-789X.2012.01037.x.
de Aquino LA, Pereira SE, de Souza Silva J, Sobrinho CJ, Ramalho A. Bariatric surgery: impact on body composition after Roux-en-Y gastric bypass. Obes Surg. 2012 Feb;22(2):195-200. doi: 10.1007/s11695-011-0500-4.
Carey DG, Pliego GJ, Raymond RL, Skau KB. Body composition and metabolic changes following bariatric surgery: effects on fat mass, lean mass and basal metabolic rate. Obes Surg. 2006 Apr;16(4):469-77. doi: 10.1381/096089206776327378.
Other Identifiers
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201310819
Identifier Type: -
Identifier Source: org_study_id
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