CardioMETProducción de Energía Cardíaca en Diabetes Tipo 2: Moléculas de Grasa vs. Moléculas de Azúcar
Este estudio observacional tiene como objetivo comparar la eficiencia con la que el corazón utiliza moléculas de grasa para la producción de energía en individuos con diabetes tipo 2 frente a individuos no diabéticos, mientras están en reposo.
Colección de datos
Recopilados desde hoy en adelante - ProspectivoDiabetes Mellitus Tipo 2+2
+ Enfermedades del Sistema Endocrino
+ Diabetes Mellitus
Casos y Controles
Examen de las características de personas con una enfermedad para identificar factores genéticos o ambientales que contribuyen a la condición.Resumen
Fecha de inicio: 5 de marzo de 2018
Fecha en la que se inscribió al primer participante.The study focuses on understanding heart health in patients with Type 2 Diabetes. Heart failure is a common complication in diabetes, often linked to how the heart muscle produces energy. Normally, heart muscles use both sugar and fat for energy, but in people with Type 2 Diabetes, the heart might rely too heavily on fat, which is less efficient. This research aims to improve our understanding of diabetic heart disease, potentially leading to new treatment approaches. During the study, participants with Type 2 Diabetes and those without diabetes will undergo tests to measure how their hearts use sugar and fat for energy, both at rest and while the heart is working harder. This will be done by comparing blood sugar and fat levels before and after they pass through the heart. To make the heart work harder, a drug called Dobutamine is used, which mimics the effects of exercise. Heart function and blood supply will also be measured using MRI scanning. The main outcome of interest is the difference in how efficiently the heart uses fat for energy between patients with Type 2 Diabetes and those without diabetes at rest.
Protocolo
Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.Se reclutarán 8 pacientes
Número total de participantes que el ensayo clínico espera reclutar.Casos y Controles
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.A partir de 18 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
Inclusion Criteria: Group 1: Type 2 diabetes cohort: 1. Participant is willing and able to give informed consent for participation in the study. 2. Aged 18 years or above. 3. Confirmed diagnosis of T2D according to World Health Organisation (WHO) criteria 4. Undergoing invasive coronary angiography for exclusion of CAD. 5. Able (in the investigator's opinion) and willing to comply with all study requirements 6. Must understand written and verbal English Group 2: Non-diabetic Controls 1. Participant is willing and able to give informed consent for participation in the study. 2. Aged 18 years or above. 3. Undergoing invasive coronary angiography for exclusion of CAD. 4. Able (in the investigator's opinion) and willing to comply with all study requirements. Exclusion Criteria: Group 1 1. Type 1 diabetes. 2. Significant CAD\> (50% luminal stenosis) 3. Significant renal impairment (eGFR\<30ml/min/m2). 4. Previous coronary artery bypass grafting surgery or myocardial infarction 5. Significant clinical established diagnosis of heart failure and EF \<40% 6. Female participants who are pregnant, lactating or planning pregnancy during the course of the study. 7. Participants who have participated in another research study involving an investigational product in the past 12 weeks 8. Atrial fibrillation. 9. Contra-indications to magnetic resonance imaging (pacemaker, cranial aneurysm clips, metallic ocular foreign bodies, severe claustrophobia). 10. Known hypersensitivity to dobutamine or gadolinium. 11. Participants with a diagnosis of significant (\>moderate,) valve disease. 1\. Patients who are on Insulin therapy, or oral Thiazolidinedione. 2. Involvement in other studies thought to compromise resulting study data or the health of the participant in the opinion of investigator. Group 2 1. As per group 1 plus 2. Diagnosis of diabetes or impaired glucose tolerance Note patients with previous CAD treated by angioplasty/stenting and no residual disease are eligible.
Plan de Estudio
Conoce todos los tratamientos administrados en este estudio, su descripción detallada y en qué consisten.Objetivos del Estudio
Objetivos Primarios
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
Glenfield Hospital, University Hospitals of Leicester NHS Trust
Leicester, United KingdomAbrir Glenfield Hospital, University Hospitals of Leicester NHS Trust en Google Maps