- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07673523
Effect of Dietary Carbohydrate Content and Inulin-Fructooligosaccharide Supplementation on Glycemic Control in Individuals With Type 1 Diabetes Mellitus
Effect of Dietary Carbohydrate Content and Inulin-Fructooligosaccharide (FOS) Supplementation on Glycemic Control in Individuals With Type 1 Diabetes Mellitus
Diabetes is a chronic metabolic disease in which nutrients such as carbohydrates, fats and proteins cannot be utilized sufficiently due to the inability to produce insulin or defects in the effect of the produced insulin. The risk of individuals encountering complications related to diabetes decreases when glycemic control is achieved in these patients. Therefore, nutrition is an necessary component of treatment. Although there are many studies in the literature examining the effect of carbohydrate intake on glycemic control in individuals with diabetes and monitoring carbohydrate intake in individuals with diabetes is the basic strategy for reaching glucose targets, a common denominator has not yet been reached for the optimal amount of carbohydrate intake for individuals with diabetes. There are a wide range of definitions regarding carbohydrate intake and studies on carbohydrate restriction, especially in individuals with Type 1 diabetes, are limited.
In present randomized controlled crossover study, three isocaloric different dietary treatment are planned to applied for 2 weeks in which (i) 30% of the daily energy requirement is provided from carbohydrates, not to fall below 130 g/day carbohydrates according to the individual characteristics of the patients, (ii) 50-55% of the daily energy requirement is provided from carbohydrates and (iii) carbohydrate content in the diet is adjusted without increasing the amount of carbohydrates, by supplementing 2 sachets (1 sachet 3.68 g inulin + 3.68 g ) where 50-55% of daily energy requirement is provided from carbohydrates together with fructooligosaccharide (FOS)) inulin fructooligosaccharide (FOS) supplementation. A 2-week washout period is planned between each diet model. The research will be conducted with 20 individuals with Type 1 diabetes using a Continuous Glucose Monitoring device. The proposed project aims to investigate the effect of different dietary treatments on glycemic control in individuals with Type 1 diabetes by using a continuous glucose measuring device. At the end of each dietary treatment application, the data obtained from the Continuous Glucose Measuring Device will be evaluated as the primary outcomes; total insulin dose, insulin/Carbohydrate ratio, total bolus insulin dose will be evaluated as the secondary outcomes. As a result of the research, the potential effects of different dietary treatments on glycemic control will be evaluated and the development of the most appropriate diet model for these patients will be contributed. In addition, this research will contribute to the improvement of the continuous glucose monitoring device.
Descripción general del estudio
Estado
Condiciones
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Ankara, Turquía (Türkiye), 06100
- Hacettepe University
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
Patients aged 18-65 years diagnosed with Type 1 diabetes and currently using a Continuous Glucose Monitoring device
Exclusion Criteria:
- Individuals with type 2 diabetes
- Individuals with gestational diabetes
- Breastfeeding individuals
- Individuals with celiac disease
- Individuals with gastroparesis
- Renal insufficiency (tGFR ≤ 60 ml/min/1.73 m2)
- Diagnosed liver failure
- Immunodeficiency
- Individuals with malignancy
- Using nutritional supplements that may affect metabolic parameters
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Poner en pantalla
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación cruzada
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: 30% of the daily energy requirement is provided from carbohydrates, not to fall below 130 g/day carb
|
Dietary carbohydrate is 30% of daily energy requirements
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Experimental: 50-55% of the daily energy requirement is provided from carbohydrates
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Dietary carbohydrate is 50-55% of daily energy requirements
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Experimental: carbohydrate content in the diet is adjusted without increasing the amount of carbohydrates, by supp
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Carbohydrate content of diet
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
|---|---|
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Continuous Glucose Measuring Device Measurements
Periodo de tiempo: From the enrollment to the end of treatment at 8 weeks
|
From the enrollment to the end of treatment at 8 weeks
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Other measurements
Periodo de tiempo: From the enrollment to the end of the treatment at 12 weeks
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total insulin dose, insulin/Carbohydrate ratio, total bolus insulin dose
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From the enrollment to the end of the treatment at 12 weeks
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Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
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
Palabras clave
Términos MeSH relevantes adicionales
- Enfermedades del sistema endocrino
- Enfermedades metabólicas
- Enfermedades autoinmunes
- Enfermedades del sistema inmunológico
- Trastornos del metabolismo de la glucosa
- Diabetes mellitus
- Enfermedades Nutricionales y Metabólicas
- Diabetes Mellitus, Tipo 1
- Carbohidratos dietéticos
- Carbohidratos
- Polímeros
- Sustancias macromoleculares
- Polisacáridos
- Almidón
- Glucanos
- Biopolímeros
- Fructanos
- Inulina
- fructooligosacárido
Otros números de identificación del estudio
- KA-24037
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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