Changes in Body Composition Following Bariatric Surgery
19 de noviembre de 2018 actualizado por: 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.
Descripción general del estudio
Descripción detallada
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.
Tipo de estudio
De observación
Inscripción (Actual)
136
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
-
-
Iowa
-
Iowa City, Iowa, Estados Unidos, 52242
- University of Iowa Hospitals and Clinics
-
-
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
18 años a 65 años (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
Sí
Géneros elegibles para el estudio
Todos
Método de muestreo
Muestra no probabilística
Población de estudio
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.
Descripción
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.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
|---|---|
|
Bariatric Surgery - Gastric Bypass
This population will undergo a laparoscopic roux-en-y gastric bypass
|
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
|
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.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Body Composition
Periodo de tiempo: Pre-op, 6 months and 12 months post-op
|
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.
|
Pre-op, 6 months and 12 months post-op
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Comorbidity resolution
Periodo de tiempo: pre-op, 6 months post-op, 12 months post-op
|
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.
|
pre-op, 6 months post-op, 12 months post-op
|
|
Protein intake and lean tissue mass
Periodo de tiempo: Pre-op, 6 months post-op, 12 months post-op
|
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.
|
Pre-op, 6 months post-op, 12 months post-op
|
|
Exercise and lean tissue mass preservation
Periodo de tiempo: Pre-op, 6 months post-op, 12 months post-op
|
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).
|
Pre-op, 6 months post-op, 12 months post-op
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Peter N Nau, MD, MS, University of Iowa
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Publicaciones Generales
- 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.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio
1 de mayo de 2014
Finalización primaria (Actual)
1 de octubre de 2018
Finalización del estudio (Actual)
1 de octubre de 2018
Fechas de registro del estudio
Enviado por primera vez
22 de mayo de 2014
Primero enviado que cumplió con los criterios de control de calidad
22 de mayo de 2014
Publicado por primera vez (Estimar)
28 de mayo de 2014
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
20 de noviembre de 2018
Última actualización enviada que cumplió con los criterios de control de calidad
19 de noviembre de 2018
Última verificación
1 de noviembre de 2018
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 201310819
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
Ensayos clínicos sobre Bariatric Surgery
-
Seattle Children's HospitalJohns Hopkins University; Duke University; Vanderbilt University; University of Utah y otros colaboradoresReclutamientoEscoliosis idiopática | Espondilolistesis | Escoliosis; Adolescencia | Cifosis | Juvenil; Escoliosis | Escoliosis; CongénitaEstados Unidos
-
AGO Study GroupCancer Research UK; ARCAGY/ GINECO GROUP; Grupo Español de Investigación en Cáncer... y otros colaboradoresTerminadoCáncer de ovarios | Cáncer de trompa de Falopio | Cáncer de cavidad peritonealEspaña, Francia, Dinamarca, Bélgica, Alemania, Austria, Porcelana, Italia, Corea, república de, Noruega, Suecia, Reino Unido
-
Kocaeli Derince Education and Research HospitalKocaeli UniversityDesconocidoRecuperación mejorada después de la cirugía | Cirugía a corazón abiertoPavo
-
University of TriesteTerminado
-
Dr. Faruk SemizInscripción por invitación
-
National Cancer Centre, SingaporeTerminadoEnfermedades de la tiroidesSingapur
-
Ethicon Endo-SurgeryTerminadoObesidadEstados Unidos, Alemania
-
University of Illinois at ChicagoEthicon Endo-SurgeryRetiradoEnfermedades del colon y del rectoEstados Unidos
-
St. Joseph's Healthcare HamiltonHamilton Academic Health Sciences OrganizationTerminadoCáncer de pulmón de células no pequeñasCanadá
-
Assistance Publique - Hôpitaux de ParisDesconocidoCirugía | Artroplastia total de rodilla | Colectomía | HisterectomíaFrancia