- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT01869790
Evaluation of Fats on Postprandial Glucose Control (Nabucco)
Development of "Fat" Bolus for Coverage of Higher Fat Meals.
The purpose of this study is examine the effect of different fat types on postprandial glucose control in patients with type 1 diabetes.
Subjects will have several admissions and, in random order, will receive lunches with identical carbohydrate content but different fat content: lunch A will minimal fat content, lunch B will contain added butter, lunch C will contain added olive oil, and lunch D will contain added cheese. Total fat content in lunches B-D will be the same. Subjects will receive identical insulin doses (calculated using the subject's usual insulin-to-carbohydrate ratio) for the meals.
The investigators hypothesize that, despite identical carbohydrate content,the lunches higher in saturated fat will lead to more postprandial hyperglycemia than the lunch containing minimal fat and the lunch high in monounsaturated fat.
The hypothesis is that from time points 0-180 minute area under the curve for Lunches A, B, C, and D will be the same, whereas from time points 180-360 minutes for Lunch B and D will be greater than that of Lunch A and C.
Descripción general del estudio
Descripción detallada
Subjects for this study will be adults with type 1 diabetes who use insulin pump in their diabetes self-management. Prior to admission the the clinical research center the basal rates and insulin-to-carbohydrate ratio of the subjects will be optimized using standard clinical procedures.
Subjects will be admitted to the clinical research center in mid-morning following a light breakfast at home. Subjects will have several admissions and, in random order, will receive lunches with identical carbohydrate content but different fat content: lunch A will minimal fat content, lunch B will contain added butter, lunch C will contain added olive oil, and lunch D will contain added cheese. Total fat content in lunches B-D will be the same. Subjects will receive identical insulin doses (calculated using the subject's usual insulin-to-carbohydrate ratio) for the meals. Blood samples for measurement of plasma glucose and insulin levels will be drawn for the subsequent 6 hours. We hypothesize that postprandial glucose levels 3-6 hours after start of the meal will be higher following lunches B and D, compared to lunches A and C.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Massachusetts
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Boston, Massachusetts, Estados Unidos, 02215
- Joslin Diabetes Center
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Adult patients (aged 18-75 years) with type 1 diabetes > 3 years.
- On insulin pump therapy.
- A1c < 8.5%.
Exclusion Criteria:
- History or symptoms suggestive of gastric dysmotility, celiac disease, pancreatic exocrine dysfunction or other conditions that cause malabsorption or maldigestion.
- Eating disorder.
- Diet allergies.
- Special diet restrictions, such as vegan or any nut allergy.
- Medications know to affect insulin sensitivity (such as glucocorticoids) or affect gastrointestinal motility (such as reglan).
- High-titre insulin autoantibodies with delayed insulin kinetics.
- Women who are breast feeding, pregnant, or wanting to become pregnant.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Experimental: Meal challenge
Different fat types
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Saturated, monounsaturated fats
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Area under the curve (AUC)
Periodo de tiempo: 0-180 minutes vs 180-360 minutes
|
One-way repeated measures ANOVA will be used to analyze area under curve differences between the three lunches as well as time in target range (80-180 mg/dL), peak blood glucose, time to peak blood glucose, time to return to baseline blood glucose.
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0-180 minutes vs 180-360 minutes
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Howard Wolpert, MD, Joslin Diabetes Center
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- Prandial bolus coverage
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
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. .
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