Dieta Baja en Grasas y Basada en Plantas vs. Dieta Controlada en Porciones para la Reducción de Lípidos Intracelulares en Diabetes Tipo 2
Este estudio compara los efectos de una dieta baja en grasas y basada en plantas con una dieta controlada en porciones sobre la reducción de lípidos intracelulares en individuos con diabetes tipo 2, mediante la medición de la concentración de péptido C, niveles de glucosa, contenido lipídico hepatocelular e intramiocelular, sensibilidad a la insulina y tasa de control glucémico.
Dietary intervention
Diabetes Mellitus Tipo 2+4
+ Enfermedades del Sistema Endocrino
+ Diabetes Mellitus
Estudio de Tratamiento
Resumen
Fecha de inicio: 1 de julio de 2025
Fecha en la que se inscribió al primer participante.This study focuses on Type 2 diabetes, a condition where the body's insulin production doesn't meet its needs, often linked to excess fat in liver and muscle cells. The research aims to compare the effects of two dietary interventions: a low-fat, plant-based diet and a portion-controlled diet that aligns with current American Diabetes Association guidelines. The goal is to see how these diets impact fat content in liver and muscle cells in adults with Type 2 diabetes. This study is important as it could provide insights into dietary strategies for improving insulin sensitivity and managing Type 2 diabetes. Participants with Type 2 diabetes will be randomly assigned to start with either the plant-based or the portion-controlled diet for 22 weeks, then switch to the other diet for another 22 weeks. Before and after each diet period, researchers will measure fat content in muscle and liver cells. They will also evaluate insulin sensitivity and blood sugar control. The study anticipates that both diets will reduce fat content in these cells, leading to improved insulin sensitivity and blood sugar control. However, it is hypothesized that the low-fat, plant-based diet will result in greater changes in cellular fat content compared to the portion-controlled diet.
Protocolo
Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.Estudio de Tratamiento
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 are as follows: 1. Men and women with type 2 diabetes treated by diet and/or oral hypoglycemic agents other that sulfonylureas 2. Age ≥18 years 3. Body mass index 26-40 kg/m2 4. Medications (antidiabetic, antihypertensive, and lipid-lowering) have been stable for the past 3 months 5. HbA1c between 6-10.5% (42-88 mmol/mol) Exclusion criteria are as follows: 1. Diabetes mellitus, type 1 and/or treatment with insulin or sulfonylureas 2. Metal implants, such as a cardiac pacemaker or an aneurysm clip 3. History of any endocrine condition that would affect body weight, such as thyroid disease, pituitary abnormality, or Cushing's syndrome 4. Smoking during the past six months 5. Alcohol consumption of more than 2 drinks per day or the equivalent, episodic increased drinking (e.g., more than 2 drinks per day on weekends), or a history of alcohol abuse or dependency followed by any current use 6. Use of recreational drugs in the past 6 months 7. Use within the preceding six months of medications that affect appetite or body weight, such as estrogens or other hormones, thyroid medications, systemic steroids, antidepressants (tricyclics, MAOIs, SSRIs), antipsychotics, lithium, anticonvulsants, appetite suppressants or other weight-loss drugs, herbs for weight loss or mood, St. John's wort, ephedra, beta blockers 8. Pregnancy or intention to become pregnant during the study period 9. Unstable medical or psychiatric illness 10. Evidence of an eating disorder 11. Likely to be disruptive in group sessions 12. Already following a low-fat, vegan diet 13. Lack of English fluency 14. Inability to maintain current medication regimen 15. Inability or unwillingness to participate in all components of the study 16. Intention to follow another weight-loss method during the trial Participants will also review and complete the Yale MRI Safety Questionnaire to determine eligibility for the study.
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
0% de probabilidad de ser asignado al grupo placebo
Grupos de Tratamiento
Grupo I
Comparador ActivoGrupo II
Comparador ActivoObjetivos 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
Physicians Committee for Responsible Medicine
Washington D.C., United StatesAbrir Physicians Committee for Responsible Medicine en Google Maps