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Crononutrición y resistencia a la insulina en la diabetes (Chrono)

Efecto de una intervención de crononutrición sobre la resistencia a la insulina en adultos con diabetes tipo 2

The goal of this randomized clinical trial is to determine the effect of a chrono nutrition intervention compared with a usual dietary intervention on insulin resistance in individuals with type 2 diabetes with overweight or obesity over a 6-month period.

The main question it aims to answer is: What is the effect of a chrono nutrition intervention compared to a standard intervention on insulin resistance in individuals with T2D (type 2 diabetes) with overweight or obesity over a 6-month period?

Participants:

  • Will be asked to fast for 12 hours each day. During the fasting period, they may consume non-caloric beverages such as plain water, coffee, or unsweetened tea.
  • They will be asked to follow a dietary plan in which the total daily calorie intake will be calculated using indirect calorimetry, subtracting 500 calories from the total calorie amount.
  • The dietary plan will have the following macronutrient distribution: 40% carbohydrates (<10% simple carbohydrates), 20% protein, and 40% fats (6-11% polyunsaturated, 15-20% monounsaturated, and <10% saturated).
  • The plan will consist of 3 meals: breakfast will account for 40% of the total calories. Dinner will include only 10% of the total grams of carbohydrates.
  • The order of food consumption should be: 1) vegetables, 2) proteins, 3) complex carbohydrates, and 4) simple carbohydrates (fruits).

Researchers will compare the chrono nutrition strategy with a standard dietary intervention to see the effect in insulin resistance.

Descripción general del estudio

Estado

Activo, no reclutando

Intervención / Tratamiento

Descripción detallada

Type 2 diabetes (T2D) is considered one of the main public health problems. During the last decade the incidence of T2D has increased exponentially leading to an increased incidence in cardiovascular disease, premature death, blindness and non-traumatic limb amputation. Novel therapeutic interventions have become imperative.

Dietary interventions are the cornerstone in managing and preventing T2D, however there is heterogeneity in the interventions and approaches currently available. The main objective of a dietary intervention is modest weight reduction achieved through calorie deficit and reduction in the consumption of carbohydrates and fats. Dietary interventions with a chrono nutrition focus establish an eating regime with calorie and macronutrient distribution taking into account sleeping and fasting hours, which are associated with metabolic alterations. This approach looks beyond calorie deficit and weight loss as primary outcomes.

Nutrition, physical activity, and education are fundamental pillars for achieving metabolic control in T2D. It is well-described that a nutritional treatment alone can improve glycemic control and the quality of life of patients. It is interesting to note that the timing of meals throughout the 24-hour period seems to play an important role, similar to the number of meals per day or the total calorie intake. Furthermore, the daily pattern of fasting-feeding is influenced by the sleep-wake cycle pattern, which is one of the most evident adaptations to circadian rhythms and plays a significant role in maintaining optimal health.

Interventions targeting aspects such as food type, meal timing, quality, and quantity can be a simple and promising strategy that can positively or negatively impact metabolic health, regardless of body weight modification. This evidence supports chrono nutrition as a novel strategy in the field of nutrition, primarily focusing on studying the interaction between nutrition, feeding, and the circadian rhythm. The implementation of new nutritional strategies based on circadian rhythms contributes to improving adherence to dietary treatment and preventing potential complications.

Tipo de estudio

Intervencionista

Inscripción (Estimado)

40

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

    • Mexico City
      • Mexico City, Mexico City, México, 14080
        • Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

18 años a 60 años (Adulto)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria:

  • Patients diagnosed with type 2 diabetes (T2D)
  • HbA1c < 8.5%
  • BMI ≥ 25 kg/m2 and < 35 kg/m2
  • Stable pharmacological treatment for the last 3 months
  • Willingness to participate in the protocol.

Exclusion Criteria:

  • Insulin treatment
  • Hospitalization in the previous three months
  • Disease with adverse prognosis (SIDA, cancer)
  • Rheumatologic diseases under immunosuppressive treatment (SLE, RA)
  • Acute infection or febrile syndrome
  • Hepatic cirrhosis
  • Glomerular filtration rate <60 ml/min
  • Other diabetes types (LADA, T1, MODY)
  • Fasting triglycerides >500 mg/dl
  • Pregnancy
  • Lactation
  • Steroid treatment
  • High performance athletes
  • Estrogen treatment
  • Weight reduction >5% in the last three months

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Chrono nutrition
  1. During the 6-month period, participants will be asked to fast for 12 hours each day. During the fasting period, they may consume non-caloric beverages such as plain water, coffee, or unsweetened tea.
  2. The total daily calorie intake will be calculated using indirect calorimetry, considering the participant's current weight, age, sex, and physical activity level. 500 calories will be subtracted from the total calorie amount.
  3. The dietary plan will have the following macronutrient distribution: 40% carbohydrates (<10% simple carbohydrates), 20% protein, and 40% fats (6-11% polyunsaturated, 15-20% monounsaturated, and <10% saturated).
  4. The plan will consist of 3 meals and breakfast will account for 40% of the total calories.
  5. During dinner, only 10% of the total grams of carbohydrates will be included.
  6. The order of food consumption should be as follows: 1) vegetables, 2) proteins, 3) complex carbohydrates, and 4) simple carbohydrates (fruits).

An integral nutritional strategy involving timing, order and distribution of macronutrients

Comparador activo: Standard
  1. The total daily calorie intake will be calculated using indirect calorimetry, considering the participant's current weight, age, sex, and physical activity level. 500 calories will be subtracted from the total calorie amount.
  2. The dietary plan will have the following macronutrient distribution: 40% carbohydrates (<10% simple carbohydrates), 20% protein, and 40% fats (6-11% polyunsaturated, 15-20% monounsaturated, and <10% saturated).
  3. The plan will consist of 3 meals with an isocaloric distribution, with each meal containing 33% of the total calories.

Conventional nutritional strategy involving isocaloric distribution with no specific timing

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Change in insulin resistance (M value)
Periodo de tiempo: Six months

Change in insulin resistance (M value) assessed with an euglycemic-hyperinsulinemic clamp.

Six months

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Change in visceral adipose (liters)
Periodo de tiempo: Six months

Change in visceral adipose tissue amount

Six months
Change in glycated hemoglobin (%)
Periodo de tiempo: Six months

Change in glycated hemoglobin

Six months
Change in lipid profile (mg/dl)
Periodo de tiempo: Six months

Change in lipid profile

Six months

Otras medidas de resultado

Medida de resultado
Medida Descripción
Periodo de tiempo
Change in hepatic steatosis and fibrosis (decibels and kilopascals)
Periodo de tiempo: Six months

Change in hepatic steatosis and fibrosis assessed with elastography

Six months
Hunger and satiety (score)
Periodo de tiempo: Six months

Change in hunger and satiety assessed with visual analog scale for hunger and satiety

Six months

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

1 de enero de 2024

Finalización primaria (Estimado)

1 de abril de 2027

Finalización del estudio (Estimado)

1 de agosto de 2027

Fechas de registro del estudio

Enviado por primera vez

5 de octubre de 2023

Primero enviado que cumplió con los criterios de control de calidad

30 de noviembre de 2023

Publicado por primera vez (Actual)

8 de diciembre de 2023

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

3 de noviembre de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

30 de octubre de 2026

Última verificación

1 de octubre de 2026

Más información

Términos relacionados con este estudio

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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