Changes in Body Composition Following Bariatric Surgery
2018年11月19日 更新者：Peter Nau
Roux-en-y Gastric Bypass Versus Sleeve Gastrectomy - Analysis of the Disparate Effects on Body Composition and Associated Comorbidity Resolution
Obesity is an important public health issue worldwide.
In the United States, the percentage of overweight and obese adults increased from 47 and 15%, respectively, to 69 and 36% in the last 40 years.
Medically supervised attempts at weight loss are fraught with failures and recidivism.
Surgical approaches to this important issue are both durable and effective.
The gold standard approach to the surgical treatment of obesity and the attendant medical comorbidities is the laparoscopic roux-en-y gastric bypass (RYGB) and the laparoscopic sleeve gastrectomy (LSG).
The mechanisms by which these two operations work and the associated side effects are not completely understood.
It is established that the RYGB induces changes in both the fatty tissue mass (FTM) and lean body mass (LBM) post-operatively.
This is associated with decreases in bone mineral density, basal metabolic rate, and potentially the ability to maintain weight loss.
There is only incomplete information on the influence that the LSG has on body composition.
This study proposes an evaluation of the changes in body composition that occurs following these two disparate operations.
Using serial measurements by the BodPod and collecting information on the patients' dietary intake, exercise habits and comorbidity resolution, this study will help to better define the influence that the LSG has on body composition.
It is hypothesized that the addition of a malabsorptive component will result in increased speed weight loss and overall weight loss which will have a negative impact in the preservation of lean tissue mass for the patient.
This information can then be used by bariatric surgeons to better cater the surgical procedure and post-operative plan to the patient's body make up and medical comorbidities.
研究概览
详细说明
Procedures
- 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.
研究类型
观察性的
注册 (实际的)
136
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
-
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Iowa
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Iowa City、Iowa、美国、52242
- University of Iowa Hospitals and Clinics
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 至 65年 (成人、年长者)
接受健康志愿者
是的
有资格学习的性别
全部
取样方法
非概率样本
研究人群
The population consists of individuals who meet the NIH consensus statement for the surgical treatment of obesity.
These individuals will have a BMI greater than 35 kg/m2 and a medical comorbidity or 40 kg/m2.
These subjects will have voluntarily initiated a consultation for bariatric surgery and completed the pre-bariatric surgery weight management program.
After failing this program, the patients will undergo surgical consultation for bariatric surgery.
It is only after this consultation that the subjects will be approached for enrollement in the study.
描述
Inclusion Criteria:
- Individuals will have a BMI greater than 35 kg/m2 and a medical comorbidity or 40 kg/m2
- Individuals must have voluntarily initiated a surgical consultation for weight loss surgery
- Individuals must have completed a medical supervised weight loss program
Exclusion Criteria:
- Failure to adequately complete the pre-screening and educational program necessary to proceed with bariatric surgery
- Those who are or become pregnant
- Individuals with severe claustrophobia.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
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Bariatric Surgery - Gastric Bypass
This population will undergo a laparoscopic roux-en-y gastric bypass
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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.
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Bariatric Surgery - Sleeve Gastrectomy
This group will undergo a laparoscopic sleeve gastrectomy
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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.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Body Composition
大体时间：Pre-op, 6 months and 12 months post-op
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Using the BodPod machine produced by Cosmed, changes in lean tissue mass and fatty tissue mass following either the laparoscopic roux-en-y gastric bypass or the laparoscopic sleeve gastrectomy will be assessed.
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Pre-op, 6 months and 12 months post-op
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Comorbidity resolution
大体时间：pre-op, 6 months post-op, 12 months post-op
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Assess for correlations between the changes in body composition and the resolution of medical comorbidities when comparing the LSG and RYGB.
This will be done using changes in medication regimen and changes in physical findings and laboratory values such as blood pressure and HbA1c.
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pre-op, 6 months post-op, 12 months post-op
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Protein intake and lean tissue mass
大体时间：Pre-op, 6 months post-op, 12 months post-op
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Assess for correlation between the preservation of lean tissue mass and daily protein intake and whether the type of operation (roux-en-y gastric bypass and sleeve gastrectomy) plays a role.
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Pre-op, 6 months post-op, 12 months post-op
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Exercise and lean tissue mass preservation
大体时间：Pre-op, 6 months post-op, 12 months post-op
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Test for a correlation between the changes in body composition and the amount of physical activity the patient takes part in and whether this is influenced by the type of procedure the patient had (roux-en-y gastric bypass versus sleeve gastrectomy).
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Pre-op, 6 months post-op, 12 months post-op
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
赞助
调查人员
- 首席研究员：Peter N Nau, MD, MS、University of Iowa
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2014年5月1日
初级完成 (实际的)
2018年10月1日
研究完成 (实际的)
2018年10月1日
研究注册日期
首次提交
2014年5月22日
首先提交符合 QC 标准的
2014年5月22日
首次发布 (估计)
2014年5月28日
研究记录更新
最后更新发布 (实际的)
2018年11月20日
上次提交的符合 QC 标准的更新
2018年11月19日
最后验证
2018年11月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.