- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT01471509
Protein, Amino Acids & Insulin & Glucagon Secretion in Humans
6 de noviembre de 2017 actualizado por: Frank Q. Nuttall, MD, PhD, Minneapolis Veterans Affairs Medical Center
The Effect of Ingestion of Foods on the Plasma Glucose and Insulin Response in Subjects With Type 2 Diabetes: Protein, Amino Acids & Insulin & Glucagon Secretion in Humans
The purpose of this study is to determine the effect of various foods and/or food substances such as fats or proteins on the blood glucose and insulin concentrations in people with and without type 2 diabetes.
Descripción general del estudio
Estado
Suspendido
Condiciones
Intervención / Tratamiento
Descripción detallada
Various foods or food substances are given as a test meal.
The metabolic response is determined at various times after the administration of the meal (e.g.
blood glucose, and other hormones and metabolites).
Tipo de estudio
Intervencionista
Inscripción (Anticipado)
300
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
-
-
Minnesota
-
Minneapolis, Minnesota, Estados Unidos, 55417
- Minneapolis VA Health Care System
-
-
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 80 años (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- Subjects with or without type 2 diabetes
- C-Peptide > 1.5 ng/ml
- Able to come to the Minneapolis VA Medical Center on several occasions over 2-4 weeks
Exclusion Criteria:
- Body mass index > 40
- hematologic abnormalities
- liver disease
- kidney disease
- congestive heart failure
- life threatening malignancies
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: Otro
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación cruzada
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Comparador de placebos: Control
240 ml water
|
240 ml water, 50 g glucose ± 1 mmol amino acid/kg lean body mass
Otros nombres:
|
Comparador activo: glucose
50 g glucose
|
240 ml water, 50 g glucose ± 1 mmol amino acid/kg lean body mass
Otros nombres:
|
Comparador activo: Amino acid
1 mmol amino acid/kg lean body mass
|
240 ml water, 50 g glucose ± 1 mmol amino acid/kg lean body mass
Otros nombres:
|
Comparador activo: amino acid plus glucose
50 g glucose plus 1 mmol amino acid/kg lean body mass
|
240 ml water, 50 g glucose ± 1 mmol amino acid/kg lean body mass
Otros nombres:
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Change in blood glucose concentration
Periodo de tiempo: several time points after ingestion of test substance
|
Test substances will be given at 0800 hr and blood drawn at several time points up to 5 hours after the meal.
|
several time points after ingestion of test substance
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Change in serum insulin concentration
Periodo de tiempo: Several time points after ingestion of test substance
|
Test substances will be given at 0800 hr and blood drawn at several time points up to 5 hours after the meal.
|
Several time points after ingestion of test substance
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Frank Q Nuttall, M.D., Ph.D., Minneapolis Veterans Affairs Medical Center
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
- Iverson JF, Gannon MC, Nuttall FQ. Ingestion of leucine + phenylalanine with glucose produces an additive effect on serum insulin but less than additive effect on plasma glucose. J Amino Acids. 2013;2013:964637. doi: 10.1155/2013/964637. Epub 2013 Jul 29.
- Iverson JF, Gannon MC, Nuttall FQ. Interaction of ingested leucine with glycine on insulin and glucose concentrations. J Amino Acids. 2014;2014:521941. doi: 10.1155/2014/521941. Epub 2014 Jul 10.
- Nuttall FQ, Mooradian AD, Gannon MC, Billington C, Krezowski P. Effect of protein ingestion on the glucose and insulin response to a standardized oral glucose load. Diabetes Care. 1984 Sep-Oct;7(5):465-70. doi: 10.2337/diacare.7.5.465.
- Nuttall FQ, Gannon MC, Wald JL, Ahmed M. Plasma glucose and insulin profiles in normal subjects ingesting diets of varying carbohydrate, fat, and protein content. J Am Coll Nutr. 1985;4(4):437-50. doi: 10.1080/07315724.1985.10720086.
- Krezowski PA, Nuttall FQ, Gannon MC, Bartosh NH. The effect of protein ingestion on the metabolic response to oral glucose in normal individuals. Am J Clin Nutr. 1986 Dec;44(6):847-56. doi: 10.1093/ajcn/44.6.847.
- Gannon MC, Nuttall FQ, Krezowski PA, Billington CJ, Parker S. The serum insulin and plasma glucose responses to milk and fruit products in type 2 (non-insulin-dependent) diabetic patients. Diabetologia. 1986 Nov;29(11):784-91. doi: 10.1007/BF00873217.
- Krezowski PA, Nuttall FQ, Gannon MC, Billington CJ, Parker S. Insulin and glucose responses to various starch-containing foods in type II diabetic subjects. Diabetes Care. 1987 Mar-Apr;10(2):205-12. doi: 10.2337/diacare.10.2.205.
- Gannon MC, Nuttall FQ. Factors affecting interpretation of postprandial glucose and insulin areas. Diabetes Care. 1987 Nov-Dec;10(6):759-63. doi: 10.2337/diacare.10.6.759.
- Nuttall FQ, Gannon MC. Quantitative importance of dietary constituents other than glucose as insulin secretagogues in type II diabetes. Diabetes Care. 1988 Jan;11(1):72-6. doi: 10.2337/diacare.11.1.72.
- Gannon MC, Nuttall FQ, Neil BJ, Westphal SA. The insulin and glucose responses to meals of glucose plus various proteins in type II diabetic subjects. Metabolism. 1988 Nov;37(11):1081-8. doi: 10.1016/0026-0495(88)90072-8.
- Gannon MC, Nuttall FQ, Westphal SA, Neil BJ, Seaquist ER. Effects of dose of ingested glucose on plasma metabolite and hormone responses in type II diabetic subjects. Diabetes Care. 1989 Sep;12(8):544-52. doi: 10.2337/diacare.12.8.544.
- Nuttall FQ, Gannon MC. Metabolic response to egg white and cottage cheese protein in normal subjects. Metabolism. 1990 Jul;39(7):749-55. doi: 10.1016/0026-0495(90)90112-p.
- Westphal SA, Gannon MC, Nuttall FQ. Metabolic response to glucose ingested with various amounts of protein. Am J Clin Nutr. 1990 Aug;52(2):267-72. doi: 10.1093/ajcn/52.2.267.
- Gannon MC, Nuttall FQ. Quantitation of the glucose area response to a meal. Diabetes Care. 1990 Oct;13(10):1095-6. doi: 10.2337/diacare.13.10.1095a. No abstract available.
- Nuttall FQ, Gannon MC. Plasma glucose and insulin response to macronutrients in nondiabetic and NIDDM subjects. Diabetes Care. 1991 Sep;14(9):824-38. doi: 10.2337/diacare.14.9.824.
- Nuttall FQ, Gannon MC, Burmeister LA, Lane JT, Pyzdrowski KL. The metabolic response to various doses of fructose in type II diabetic subjects. Metabolism. 1992 May;41(5):510-7. doi: 10.1016/0026-0495(92)90210-2.
- Gannon MC, Nuttall FQ, Lane JT, Burmeister LA. Metabolic response to cottage cheese or egg white protein, with or without glucose, in type II diabetic subjects. Metabolism. 1992 Oct;41(10):1137-45. doi: 10.1016/0026-0495(92)90300-y.
- Khan MA, Gannon MC, Nuttall FQ. Glucose appearance rate following protein ingestion in normal subjects. J Am Coll Nutr. 1992 Dec;11(6):701-6. doi: 10.1080/07315724.1992.10718270.
- Gannon MC, Ercan N, Westphal SA, Nuttall FQ. Effect of added fat on plasma glucose and insulin response to ingested potato in individuals with NIDDM. Diabetes Care. 1993 Jun;16(6):874-80. doi: 10.2337/diacare.16.6.874.
- Ercan N, Nuttall FQ, Gannon MC, Lane JT, Burmeister LA, Westphal SA. Plasma glucose and insulin responses to bananas of varying ripeness in persons with noninsulin-dependent diabetes mellitus. J Am Coll Nutr. 1993 Dec;12(6):703-9. doi: 10.1080/07315724.1993.10718362.
- Ercan N, Nuttall FQ, Gannon MC, Redmon JB, Sheridan KJ. Effects of glucose, galactose, and lactose ingestion on the plasma glucose and insulin response in persons with non-insulin-dependent diabetes mellitus. Metabolism. 1993 Dec;42(12):1560-7. doi: 10.1016/0026-0495(93)90151-d.
- Ercan N, Gannon MC, Nuttall FQ. Effect of added fat on the plasma glucose and insulin response to ingested potato given in various combinations as two meals in normal individuals. Diabetes Care. 1994 Dec;17(12):1453-9. doi: 10.2337/diacare.17.12.1453.
- Gannon MC, Nuttall FQ, Lane JT, Fang S, Gupta V, Sandhofer CR. Effect of 24 hours of starvation on plasma glucose and insulin concentrations in subjects with untreated non-insulin-dependent diabetes mellitus. Metabolism. 1996 Apr;45(4):492-7. doi: 10.1016/s0026-0495(96)90225-5.
- Gannon MC, Nuttall FQ, Grant CT, Ercan-Fang S, Ercan-Fang N. Stimulation of insulin secretion by fructose ingested with protein in people with untreated type 2 diabetes. Diabetes Care. 1998 Jan;21(1):16-22. doi: 10.2337/diacare.21.1.16.
- Holtschlag DJ, Gannon MC, Nuttall FQ. State-space models of insulin and glucose responses to diets of varying nutrient content in men and women. J Appl Physiol (1985). 1998 Sep;85(3):935-45. doi: 10.1152/jappl.1998.85.3.935.
- Gannon MC, Nuttall FQ, Westphal SA, Fang S, Ercan-Fang N. Acute metabolic response to high-carbohydrate, high-starch meals compared with moderate-carbohydrate, low-starch meals in subjects with type 2 diabetes. Diabetes Care. 1998 Oct;21(10):1619-26. doi: 10.2337/diacare.21.10.1619.
- Nuttall FQ, Khan MA, Gannon MC. Peripheral glucose appearance rate following fructose ingestion in normal subjects. Metabolism. 2000 Dec;49(12):1565-71. doi: 10.1053/meta.2000.18553.
- Gannon MC, Khan MA, Nuttall FQ. Glucose appearance rate after the ingestion of galactose. Metabolism. 2001 Jan;50(1):93-8. doi: 10.1053/meta.2001.19442.
- Gannon MC, Nuttall JA, Damberg G, Gupta V, Nuttall FQ. Effect of protein ingestion on the glucose appearance rate in people with type 2 diabetes. J Clin Endocrinol Metab. 2001 Mar;86(3):1040-7. doi: 10.1210/jcem.86.3.7263.
- Saeed A, Jones SA, Nuttall FQ, Gannon MC. A fasting-induced decrease in plasma glucose concentration does not affect the insulin response to ingested protein in people with type 2 diabetes. Metabolism. 2002 Aug;51(8):1027-33. doi: 10.1053/meta.2002.34033.
- Gannon MC, Nuttall JA, Nuttall FQ. Oral arginine does not stimulate an increase in insulin concentration but delays glucose disposal. Am J Clin Nutr. 2002 Nov;76(5):1016-22. doi: 10.1093/ajcn/76.5.1016.
- Gannon MC, Nuttall JA, Nuttall FQ. The metabolic response to ingested glycine. Am J Clin Nutr. 2002 Dec;76(6):1302-7. doi: 10.1093/ajcn/76.6.1302.
- Nuttall FQ, Gannon MC, Saeed A, Jordan K, Hoover H. The metabolic response of subjects with type 2 diabetes to a high-protein, weight-maintenance diet. J Clin Endocrinol Metab. 2003 Aug;88(8):3577-83. doi: 10.1210/jc.2003-030419.
- Gannon MC, Nuttall FQ, Saeed A, Jordan K, Hoover H. An increase in dietary protein improves the blood glucose response in persons with type 2 diabetes. Am J Clin Nutr. 2003 Oct;78(4):734-41. doi: 10.1093/ajcn/78.4.734.
- Nuttall FQ, Gannon MC, Jordan K. The metabolic response to ingestion of proline with and without glucose. Metabolism. 2004 Feb;53(2):241-6. doi: 10.1016/j.metabol.2003.09.013.
- Gannon MC, Nuttall FQ. Effect of a high-protein, low-carbohydrate diet on blood glucose control in people with type 2 diabetes. Diabetes. 2004 Sep;53(9):2375-82. doi: 10.2337/diabetes.53.9.2375.
- Nuttall FQ, Gannon MC. The metabolic response to a high-protein, low-carbohydrate diet in men with type 2 diabetes mellitus. Metabolism. 2006 Feb;55(2):243-51. doi: 10.1016/j.metabol.2005.08.027.
- Nuttall FQ, Schweim KJ, Gannon MC. Effect of orally administered phenylalanine with and without glucose on insulin, glucagon and glucose concentrations. Horm Metab Res. 2006 Aug;38(8):518-23. doi: 10.1055/s-2006-949523.
- Kalogeropoulou D, Lafave L, Schweim K, Gannon MC, Nuttall FQ. Leucine, when ingested with glucose, synergistically stimulates insulin secretion and lowers blood glucose. Metabolism. 2008 Dec;57(12):1747-52. doi: 10.1016/j.metabol.2008.09.001.
- Kalogeropoulou D, LaFave L, Schweim K, Gannon MC, Nuttall FQ. Lysine ingestion markedly attenuates the glucose response to ingested glucose without a change in insulin response. Am J Clin Nutr. 2009 Aug;90(2):314-20. doi: 10.3945/ajcn.2008.27381. Epub 2009 Jun 24.
- Radulescu A, Hassan Y, Gannon MC, Nuttall FQ. The degree of saturation of fatty acids in dietary fats does not affect the metabolic response to ingested carbohydrate. J Am Coll Nutr. 2009 Jun;28(3):286-95. doi: 10.1080/07315724.2009.10719783.
- Radulescu A, Gannon MC, Nuttall FQ. The effect on glucagon, glucagon-like peptide-1, total and acyl-ghrelin of dietary fats ingested with and without potato. J Clin Endocrinol Metab. 2010 Jul;95(7):3385-91. doi: 10.1210/jc.2009-2559. Epub 2010 May 5.
- Gannon MC, Nuttall FQ. Amino acid ingestion and glucose metabolism--a review. IUBMB Life. 2010 Sep;62(9):660-8. doi: 10.1002/iub.375.
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 agosto de 1982
Finalización primaria (Actual)
6 de noviembre de 2017
Finalización del estudio (Anticipado)
6 de noviembre de 2017
Fechas de registro del estudio
Enviado por primera vez
10 de noviembre de 2011
Primero enviado que cumplió con los criterios de control de calidad
14 de noviembre de 2011
Publicado por primera vez (Estimar)
15 de noviembre de 2011
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
8 de noviembre de 2017
Última actualización enviada que cumplió con los criterios de control de calidad
6 de noviembre de 2017
Última verificación
1 de noviembre de 2017
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 676
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. .