Impact of Meal Composition and Alcohol Consumption on Postprandial Glycemic Control in Subjects With Type 1 Diabetes
Evaluación Del Impacto de la composición Nutricional de la Ingesta y Del Consumo de Alcohol en el Control glucémico Postprandial en Pacientes Con Diabetes Tipo 1
Postprandial glucose control is a challenging issue in everyday diabetes care. Indeed, excessive postprandial glucose excursions are the major contributors to plasma glucose (PG) variability in subjects with type 1 diabetes (T1DM). In addition, the poor reproducibility of postprandial glucose response is burdensome for patients and healthcare professionals.
To date, the majority of prandial insulin dosing algorithms for subjects with T1DM considers only the carbohydrate (CHO) content of the meal. However, there is evidence (although with a certain degree of heterogeneity) that meal composition significantly affects postprandial glucose control, contributing to glycemic variability. Moreover, despite the high prevalence of alcohol consumption among patients with T1DM (about 30%, similar to that of the general population), data regarding its effect on the postprandial period are very limited.
This project will evaluate the effect of meal composition and alcohol consumption on postprandial glucose control in subjects with T1DM under intensive insulin treatment.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Randomized, prospective, single-centre (Hospital Francesc de Borja, Gandia, Spain), single-blind (analysis), three -way, crossover study on type 1 diabetic subjects (n=12) under intensive insulin treatment.
Aim:
To assess the effect of mixed meal composition on postprandial glycemic control, in subjects with type 1 diabetes:
- Combined effect of proteins and fats
- Effect of alcohol consumption
Methods:
Each subject will undergo three mixed meal test studies (on three different days), with identical CHO content: On one occasion a low fat-low protein meal will be given, and on another a high fat-high protein one, both consumed with a non-alcoholic drink; on a third occasion the same high fat-high protein meal will be consumed, but this time accompanied by an equal volume of an alcoholic drink.
Patients will arrive at the research unit at 8:00 am and their blood glucose will be stabilized around 90 mg/dl before each mixed meal test. After the mixed meal, blood will be drawn every 5-30 min during a 6 hour post-prandial period to assess plasma glucose, hormones and metabolites concentration.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Valencia
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Gandia, Valencia, España, 46072
- Hospital Francesc de Borja
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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:
Patients with type 1 diabetes mellitus for more than one year, aged between 18 and 60 years; on intensive insulin therapy by means of CSII (continuous subcutaneous insulin infusion) or MDI (multiple daily injections) for at least 6 months before screening; glycosylated haemoglobin of 6-8.5%; without severe chronic micro- and macroangiopathic diabetic complications and with a body mass index (BMI) between 18 and 30 kg/m2.
Exclusion Criteria:
- Pregnancy and lactation
- Hypoglycemia unawareness
- Fatal or progressive disease
- Drugs or alcohol abuse
- HIV, active hepatitis B, active hepatitis C
- Hepatic disease (aminotransferases AST or ALT >2 times above normal)
- Clinically relevant microangiopathic disease, or other diseases that may interfere with participation in the study or data analysis
- Pre-planned surgery
- Blood donation in the previous 3 months for men and 6 months for women
- Mental conditions that may interfere with the subject's comprehension of the aims and possible consequences of the study
- Non-compliant subjects
- Use of experimental medications or devices during the previous 30 days
Plan de estudios
¿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 |
|---|---|
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Comparador activo: Low Protein-Low Fat study
Subjects will receive a mixed meal with carbohydrates (70g) plus a low content of proteins and fats
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A mixed meal with identical amount of carbohydrates but different content of protein, fat and alcohol will be given
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Experimental: High Protein-High Fat study
Subjects will receive a mixed meal with the same carbohydrates content of arm 1 (70g), but a greater amount of fats and proteins
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A mixed meal with identical amount of carbohydrates but different content of protein, fat and alcohol will be given
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Experimental: High Protein-High Fat & alcohol study
Subjects will receive the same mixed meal of the High Protein-High Fat study plus 0,7g of alcohol per Kg of weight
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A mixed meal with identical amount of carbohydrates but different content of protein, fat and alcohol will be given
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Plasma Glucose
Periodo de tiempo: 6 hours (plasma glucose will be measured every 5-15 minutes during the 6-hour post-prandial period of each mixed meal test).
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Post-prandial plasma glucose time series
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6 hours (plasma glucose will be measured every 5-15 minutes during the 6-hour post-prandial period of each mixed meal test).
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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AUC-PG
Periodo de tiempo: AUC of plasma glucose will be calculated for the whole 6 hour post-prandial period, for the early 0-3 hour post-prandial period and for the late 3-6 hour post-prandial period.
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Area Under the Curve (AUC) of Plasma Glucose in the 0-6h, 0-3h and 3-6h post-prandial periods
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AUC of plasma glucose will be calculated for the whole 6 hour post-prandial period, for the early 0-3 hour post-prandial period and for the late 3-6 hour post-prandial period.
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Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Time in range
Periodo de tiempo: 6 hours (time in range during the 6 hour post-prandial period)
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Time in acceptable glucose range (70-180 mg/dl)
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6 hours (time in range during the 6 hour post-prandial period)
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C Max
Periodo de tiempo: 6 hours (maximum plasma glucose concentration during the 6 hour post-prandial period)
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Maximum of plasma glucose concentration
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6 hours (maximum plasma glucose concentration during the 6 hour post-prandial period)
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T max
Periodo de tiempo: 6 hours (Time of maximum plasma glucose concentration during the 6 hour post-prandial period)
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Time of Maximum plasma glucose concentration
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6 hours (Time of maximum plasma glucose concentration during the 6 hour post-prandial period)
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Hormones and metabolites
Periodo de tiempo: 6 hours (plasma hormones and metabolites will be measured every 30 minutes during the 6-hour post-prandial period)
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Plasma concentration of free fatty acids, beta-OH-butyrate, lactate, alanine, counterregulatory hormones
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6 hours (plasma hormones and metabolites will be measured every 30 minutes during the 6-hour post-prandial period)
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Paolo Rossetti, PhD, Hospital Francesc de Borja, Gandia
- Director de estudio: Jorge Bondia Company, PhD, Universitat Politècnica de València
Publicaciones y enlaces útiles
Publicaciones Generales
- Bell KJ, Smart CE, Steil GM, Brand-Miller JC, King B, Wolpert HA. Impact of fat, protein, and glycemic index on postprandial glucose control in type 1 diabetes: implications for intensive diabetes management in the continuous glucose monitoring era. Diabetes Care. 2015 Jun;38(6):1008-15. doi: 10.2337/dc15-0100.
- Bell KJ, Toschi E, Steil GM, Wolpert HA. Optimized Mealtime Insulin Dosing for Fat and Protein in Type 1 Diabetes: Application of a Model-Based Approach to Derive Insulin Doses for Open-Loop Diabetes Management. Diabetes Care. 2016 Sep;39(9):1631-4. doi: 10.2337/dc15-2855. Epub 2016 Jul 7.
- Barnard K, Sinclair JM, Lawton J, Young AJ, Holt RI. Alcohol-associated risks for young adults with Type 1 diabetes: a narrative review. Diabet Med. 2012 Apr;29(4):434-40. doi: 10.1111/j.1464-5491.2012.03579.x.
- Turner BC, Jenkins E, Kerr D, Sherwin RS, Cavan DA. The effect of evening alcohol consumption on next-morning glucose control in type 1 diabetes. Diabetes Care. 2001 Nov;24(11):1888-93. doi: 10.2337/diacare.24.11.1888.
- Kerr D, Cheyne E, Thomas P, Sherwin R. Influence of acute alcohol ingestion on the hormonal responses to modest hypoglycaemia in patients with Type 1 diabetes. Diabet Med. 2007 Mar;24(3):312-6. doi: 10.1111/j.1464-5491.2006.02054.x.
- Garcia A, Moscardo V, Ramos-Prol A, Diaz J, Boronat M, Bondia J, Rossetti P. Effect of meal composition and alcohol consumption on postprandial glucose concentration in subjects with type 1 diabetes: a randomized crossover trial. BMJ Open Diabetes Res Care. 2021 Oct;9(1):e002399. doi: 10.1136/bmjdrc-2021-002399.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
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 (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
Otros números de identificación del estudio
- DPI2016-78831-C2-1-R_alcohol
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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Ensayos clínicos sobre Diabetes Mellitus, Tipo 1
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National Institute of Allergy and Infectious Diseases...PPD; Rho Federal Systems Division, Inc.; Immune Tolerance Network (ITN)TerminadoDiabetes mellitus tipo 1 | DM1 | DT1 | Diabetes mellitus tipo 1 de nueva apariciónEstados Unidos, Australia
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SanofiTerminadoDiabetes Mellitus Tipo 1-Diabetes Mellitus Tipo 2Hungría, Federación Rusa, Alemania, Polonia, Japón, Estados Unidos, Finlandia
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Hoffmann-La RocheRoche DiagnosticsTerminadoDiabetes Mellitus Tipo 2, Diabetes Mellitus Tipo 1Alemania