Use of Diazoxide in Acute Hypoglycaemia
Diazoxide
+ Placebo
Enfermedades del Sistema Endocrino+5
+ Enfermedades Autoinmunes
+ Diabetes Mellitus
Estudio de Prevención
Resumen
Fecha de inicio: 1 de enero de 2012
Fecha en la que se inscribió al primer participante.This will be conducted in a double blinded (neither subject nor the researcher will know the order of the IMP(drug/placebo). All subjects will receive both the active drug and placebo in a random fashion (crossover design). Once identified, patients will be given a participant information sheet. They will be contacted at a later date (minimum 24 hours) to determine if they are willing to participate in the trial. Subjects will then be consented, and attend a screening visit, where it will be ascertained whether they fit the inclusion/exclusion criteria. Further details of the study will also be given to them at this visit. They will then attend a few days before the first study, and will be shown how to use the continuous glucose monitor which will measure their glucose overnight, prior to the start of the study. The reason for this, is that if they have very low blood sugars the night before the study, this can influence the results of the study, and they will be given an alternative day to attend. Provided they have been free of any hypoglycaemic episodes, the night before, they can then proceed with the study. On the day of the study,we will place two intravenous cannulae. The cannulae in the hand vein will be placed in a warm chamber, in order to make it more more reflective of sampling at the blood brain barrier. The subject will either have the investigational medicinal product (diazoxide) or placebo. Blood pressure and heart rate will be monitored throughout the clamp study. After 2 hours, with the use of insulin and dextrose, the subject's blood sugar will be brought to near normal and kept there for 40 minutes. After this, the blood sugar will be dropped in stages, until a blood sugar of 2.5mmol/L is reached. The blood sugar will be monitored very closely, with 5 minute sampling taken through one of the cannulue in situ, to avoid repeated stabbing. Also at regular intervals, blood samples will be taken for measurement of hormones, including adrenaline. At each stage, subjects will be asked about symptoms they are experiencing and a series of verbal working memory tests will also be performed.
Protocolo
Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.Se reclutarán 12 pacientes
Número total de participantes que el ensayo clínico espera reclutar.Estudio de Prevención
Elegibilidad
Los investigadores buscan pacientes que cumplan ciertos criterios, conocidos como criterios de elegibilidad: estado general de salud o tratamientos previos.Cualquier sexo
Sexo biológico de los participantes elegibles para inscribirse.De 18 a 55 años
Rango de edades de los participantes que pueden unirse al estudio.Voluntarios sanos no permitidos
Indica si personas sanas, sin la condición que se estudia, pueden participar.Condiciones
Patología
Criterios
Plan de Estudio
Conoce todos los tratamientos administrados en este estudio, su descripción detallada y en qué consisten.2 grupos de intervención están designados en este estudio
50% de probabilidad de ser asignado al grupo placebo
Grupos de Tratamiento
Grupo I
Comparador ActivoGrupo II
PlaceboObjetivos del Estudio
Objetivos Primarios
Objetivos Secundarios
Centros del Estudio
Estos son los hospitales, clínicas o centros de investigación donde se lleva a cabo el estudio. Puedes encontrar la ubicación más cercana a ti y su estado de reclutamiento.Este estudio tiene una ubicación