- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT00887393
Effect of Macrocomposition on Nonalcoholic Fatty Liver Disease (NAFLD) in Bariatric Surgery Candidates
17 de junio de 2013 actualizado por: Elif Oral, University of Michigan
Nonalcoholic Liver disease (NAFLD) is known to be caused by deposition of fat in the liver.
The impact of NAFLD on bariatric surgery is of great concern.
Enlarged fatty livers increase the operative complications of bariatric surgery and weight loss prior to bariatric surgery has been shown to reduce complications of surgery.
Most bariatric surgery programs use a conventional low fat, calorie restricted diet during the preparation phase for surgery.
The investigators will compare the effects of the low carbohydrate versus the low fat diets on weight loss, reduction in liver fat content, and liver size.
These results will provide new clinical insights into the optimal dietary intervention to make bariatric surgery safe and effective for the increasing numbers of patients opting for this aggressive therapy for morbid obesity.
Patients approved for bariatric surgery by the University of Michigan Bariatric Surgery multidisciplinary committee will be randomly assigned to either a 1000 to 1200 calorie low fat or low carbohydrate, 8-week study diet.
All the food for this study will be provided for free by the study team.
Participants will be required to meet with the study team weekly to pick up study food and for a nutritional consult.
These visits will occur in the eight weeks preceding the patient's bariatric surgery procedure.
During the bariatric surgery, a liver biopsy will be performed to assess the impact of the study diet on liver fat content.
Descripción general del estudio
Estado
Terminado
Intervención / Tratamiento
Descripción detallada
The obesity epidemic has lead to increased morbidity and morality from cardiovascular disease and Type 2 diabetes.
One co-morbidity of obesity is nonalcoholic fatty liver disease (NAFLD), which is characterized by excess fat deposition in the liver.
About a third of the overweight and obese population has NAFLD and this rises to 80 to 90% of morbidity in obese patients.
Short-term weight loss and caloric restriction leads to a reduction in hepatic fat content, suggesting an ability of the liver to quickly respond to dietary interventions.
Manipulation of the diet macronutrient composition in order to achieve quicker weight loss as well as improve adverse metabolic consequences attributable to excess weight has attracted much attention and controversy.
Multiple clinical studies have shown that low carbohydrate diets can provide more rapid weight loss in individuals in the short-term and that most have no trouble adhering to the diet for up to 6 months.
Most bariatric surgery programs use a conventional low fat, calorie restricted diet during the preparation phase for surgery.
However, no systematic comparison of diets with different macronutrient compositions have been performed.
In this study we propose to compare the clinical effects of a low carbohydrate versus a low fat diet in individuals which can derive an immediate benefit from interventions that have the potential to reduce hepatic fat content: individuals that are preparing for bariatric surgery (laparoscopic Roux-en-Y gastric bypass surgery or adjustable laparoscopic gastric banding).
Enlarged steatotic livers increase the operative risk of bariatric surgery and weight loss prior to bariatric surgery has been shown to reduce operative risk.
We hypothesize that the use of a 1000 to 1200 kcalorie low carbohydrate diet (< 15% of total kcaloric intake) during the preparation phase for bariatric surgery will cause a greater reduction in weight, hepatic fat content and hepatic volume compared to a "conventional" 1000 to 1200 kcalorie low-fat diet (30% fat, 60% carbohydrates of total kcaloric intake) and offer clinical advantages by making the technical aspects of surgery easier.
Thus, the data collected will provide significant new clinical insights into the effect of diets with different macronutrient composition.
These results will provide a basis for larger clinical trials to identify the optimal dietary intervention to make bariatric surgery safe and effective for the increasing numbers of patients opting for this aggressive therapy for morbid obesity.
Tipo de estudio
Intervencionista
Inscripción (Actual)
31
Fase
- No aplica
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
-
-
Michigan
-
Ann Arbor, Michigan, Estados Unidos, 48109
- University of Michigan Hospital
-
-
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 55 años (Adulto)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- Participants will be deemed as appropriate candidates by the University of Michigan Bariatric Surgery multidisciplinary committee to undergo laparoscopic Roux-Y gastric bypass surgery or adjustable laparoscopic banding surgery
- Age 18 to 65 years
- Willing and able to give informed consent
- Clinical diagnosis of non-alcoholic fatty liver disease based on presence of abnormal LFTS and/or abnormal liver ultrasound
- Able to have an MRI procedure (able to fit into scanner, largest width < 60 cm, weight < 400 lbs, largest girth < 74 inches, do not have a pacemaker, artificial limbs or any other medical devices that contain iron that may be affected by the MRI procedure).
- Willing and able to tolerate the MRI procedure (use of benzodiazepines to complete the procedure is allowed if needed and deemed safe by the study team)
Exclusion Criteria:
- Clinical history of diabetes or fasting glucose > 126 mg/dl
- Alcohol consumption of > 40 grams/week
- Any other liver disease
- BMI < 40 kg/m2
- Unable to ambulate
- Any other factor that in the opinion of the PI or co-investigators which may impede successful completion of the study
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
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Otro: Low carbohydrate
Low carbohydrate pre-bariatric surgery diet
|
1000 to 1200 kcalorie low carbohydrate diet (< 15% of total kcaloric intake)
|
Otro: Low fat
Low fat pre-bariatric surgery diet
|
1000 to 1200 kcalorie low-fat diet (30% fat, 60% carbohydrates of total kcaloric intake)
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
---|---|
Determine the efficacy of a low carbohydrate vs. a conventional low fat diet to reduce hepatic steatosis
Periodo de tiempo: 8-9 weeks
|
8-9 weeks
|
Compare differences in weight loss with a 2 month hypocaloric conventional low fat vs. low carbohydrate diets in individuals who are candidates for laparoscopic Roux-en-Y gastric bypass surgery or adjustable laparoscopic banding surgery
Periodo de tiempo: 8-9 weeks
|
8-9 weeks
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Elif A Oral, M.D., University of Michigan
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.
Enlaces Útiles
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 abril de 2009
Finalización primaria (Actual)
1 de septiembre de 2012
Finalización del estudio (Actual)
1 de diciembre de 2012
Fechas de registro del estudio
Enviado por primera vez
22 de abril de 2009
Primero enviado que cumplió con los criterios de control de calidad
23 de abril de 2009
Publicado por primera vez (Estimar)
24 de abril de 2009
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
18 de junio de 2013
Última actualización enviada que cumplió con los criterios de control de calidad
17 de junio de 2013
Última verificación
1 de junio de 2013
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- MCRU 2462
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 low carbohydrate diet
-
University of MichiganNational Institute on Drug Abuse (NIDA); Brown University; Pennington Biomedical... y otros colaboradoresReclutamiento
-
Mondelēz International, Inc.KGK Science Inc.Terminado
-
National Institute of Diabetes and Digestive and...TerminadoObesidad | Pérdida de peso | Aumento de peso | Terapia de dieta | Terapia NutricionalEstados Unidos
-
Anumana, Inc.Mayo ClinicAún no reclutandoFracción de eyección ventricularEstados Unidos
-
DePuy InternationalTerminadoArtroplastia, Reemplazo, RodillaIrlanda
-
Fondazione Policlinico Universitario Agostino Gemelli...DesconocidoMortalidad perioperatoriaItalia
-
University of CalgaryStewart Diabetes Education FundTerminadoObesidad | Diabetes mellitus tipo 2Canadá
-
University of California, Los AngelesTerminadoEstado prediabéticoEstados Unidos
-
Vegenat, S.A.DesconocidoEnfermedad de Parkinson | Enfermedad de alzheimer | Demencia senilEspaña
-
NYU Langone HealthRetirado