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Dietary Intervention Trial Targeting Metabolic Syndrome After Kidney Transplantation (DIETTX)

5 de enero de 2021 actualizado por: Stephan J.L. Bakker, University Medical Center Groningen

Dietary Intervention Trial Targeting Metabolic Syndrome After Renal Transplantation

Kidney transplant recipients (KTR) have a considerably lower life expectancy as compared with the general population, primarily due to a high prevalence of cardiovascular diseases. KTR often develop an unfavourable cardio-metabolic risk profile characterized by weight gain, metabolic syndrome and post-transplantation diabetes mellitus (PTDM). In general, nutrition plays a key role in both the prevention and treatment of these cardio-metabolic derangements.

However, in KTR most RCT's with a dietary intervention, failed to show significant improvement in cardio-metabolic health. This at least questions the efficacy of the diets of these intervention, which relied on general or diabetes guidelines, after kidney transplantation. KTR not only face a high cardio-metabolic risk, but also have a high risk for malnutrition and muscle mass depletion. More knowledge is required to determine the optimal diet and macronutrient composition for improvement of the cardio-metabolic risk factors in the context of the high malnutrition risk. In this regard, observational studies point towards the needs for a higher protein intake for better patient outcomes. Therefore, in this study, the investigators will examine if a high-protein, carbohydrate-reduced diet is more effective than a diet in line with the Dutch Dietary Guidelines for improvement of cardio-metabolic risk factors and for improvement of the body composition in KTR.

Descripción general del estudio

Estado

Aún no reclutando

Condiciones

Intervención / Tratamiento

Tipo de estudio

Intervencionista

Inscripción (Anticipado)

30

Fase

  • No aplica

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 y mayores (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria:

  • Age 18 years or older.
  • Given informed consent.
  • At least 6 months after kidney transplantation.
  • Stable renal function with an estimated glomerular filtration rate (eGFR) > 30 mL/min.
  • Raised systolic blood pressure (≥130 mmHg) and at least two more features of metabolic syndrome: central obesity (waist circumference ≥102 for men and ≥88cm for women), elevated triglycerides (≥ 1.7 mmol/L), reduced HDL-C (< 1.0 mmol/L for men and < 1.3 mmol/L for women) or on drug treatment for reduced HDL, elevated plasma glucose (≥ 5.6 mmol/L) or on drug treatment for elevated glucose9.
  • Approval by nephrologist for participation in the study.

Exclusion Criteria:

  • Active medical illness, including rejection of the graft.
  • Psychopathology or serious cognitive impairment.
  • Necessity to follow specific dietary measures for health purposes that conflict with the study diets.
  • Use of insulin or sulfonylurea (SU)-derivates.
  • Language barrier.
  • Pregnancy or lactating.
  • Serum potassium > 5.0 mmol/L that requires dietary measures.
  • Moderate or severe malnutrition (Patient-Generated Subjective Global Assessment (PG-SGA) stage B or C). In this case, patient will be referred to a renal dietician.
  • Participation in other intervention trials.

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 cruzada
  • Enmascaramiento: Único

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: high-protein, carbohydrate-reduced diet
Otro: high-protein, carbohydrate-reduced diet
the high-protein, carbohydrate-reduced diet will consist of 1.2-1.4 g/kg/d protein, 26-20en% carbohydrates and +/- 50en% fatty acids, with mainly unsaturated fatty acids. This diet consist of mainly unprocessed, fresh nutrient-dense food-products. Ultra-processed foods and alcoholic beverages will be totally avoided. Salt consumption will not exceed 5-6 g/d. The diet is ad libitum and caloric restriction will not be applied. The diet will be followed for 6 weeks.
Comparador activo: Dutch Nutritional Guidelines
Otro: Dutch Nutritional Guidelines
the diet according to the Dutch Nutritional Guidelines will consist of a protein intake of 0.8-1.0 g/kg/d and 50-60en% carbohydrates, and +/-30en% fatty acids, with restriction of saturated fatty acids <10en%. This diet consist of mainly unprocessed, fresh nutrient-dense food-products. Ultra-processed foods and alcoholic beverages will be totally avoided. Salt consumption will not exceed 5-6 g/d. The diet is ad libitum and caloric restriction will not be applied. The diet will be followed for 6 weeks.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Systolic blood pressure
Periodo de tiempo: before and after experimental diet (high-protein, carbohydrate-reduced diet - 6 weeks) / before and after active comparator (Dutch Nutritional Guidelines - 6 weeks) / wash-out period in between (6 weeks)
Change in systolic blood pressure (in mmHg)
before and after experimental diet (high-protein, carbohydrate-reduced diet - 6 weeks) / before and after active comparator (Dutch Nutritional Guidelines - 6 weeks) / wash-out period in between (6 weeks)

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Cardio-metabolic risk factors (lipids)
Periodo de tiempo: before and after experimental diet (high-protein, carbohydrate-reduced diet - 6 weeks) / before and after active comparator (Dutch Nutritional Guidelines - 6 weeks) / wash-out period in between (6 weeks)
change in circulating triglyceride concentrations, low-density lipoprotein cholesterol (LDL-C) and HDL-C (in fasting serum levels) in mmol/L.
before and after experimental diet (high-protein, carbohydrate-reduced diet - 6 weeks) / before and after active comparator (Dutch Nutritional Guidelines - 6 weeks) / wash-out period in between (6 weeks)
Cardio-metabolic risk factors (diastolic blood pressure)
Periodo de tiempo: before and after experimental diet (high-protein, carbohydrate-reduced diet - 6 weeks) / before and after active comparator (Dutch Nutritional Guidelines - 6 weeks) / wash-out period in between (6 weeks)
Change in diastolic blood pressure (in mmHg)
before and after experimental diet (high-protein, carbohydrate-reduced diet - 6 weeks) / before and after active comparator (Dutch Nutritional Guidelines - 6 weeks) / wash-out period in between (6 weeks)
Cardio-metabolic risk factors (waist circumference)
Periodo de tiempo: before and after experimental diet (high-protein, carbohydrate-reduced diet - 6 weeks) / before and after active comparator (Dutch Nutritional Guidelines - 6 weeks) / wash-out period in between (6 weeks)
change in waist circumference (WC) in cm
before and after experimental diet (high-protein, carbohydrate-reduced diet - 6 weeks) / before and after active comparator (Dutch Nutritional Guidelines - 6 weeks) / wash-out period in between (6 weeks)
Cardio-metabolic risk factors (insulin resistance)
Periodo de tiempo: before and after experimental diet (high-protein, carbohydrate-reduced diet - 6 weeks) / before and after active comparator (Dutch Nutritional Guidelines - 6 weeks) / wash-out period in between (6 weeks)
change in insulin resistance measuring by the homeostatic model assessment of insulin resistance (HOMA-IR index, fasting glucose, insulin)
before and after experimental diet (high-protein, carbohydrate-reduced diet - 6 weeks) / before and after active comparator (Dutch Nutritional Guidelines - 6 weeks) / wash-out period in between (6 weeks)
Body composition
Periodo de tiempo: before and after experimental diet (high-protein, carbohydrate-reduced diet - 6 weeks) / before and after active comparator (Dutch Nutritional Guidelines - 6 weeks) / wash-out period in between (6 weeks)
change in fat and muscle mass measured by multi-frequency bio-electrical impedance analysis (BIA) BMI, weight
before and after experimental diet (high-protein, carbohydrate-reduced diet - 6 weeks) / before and after active comparator (Dutch Nutritional Guidelines - 6 weeks) / wash-out period in between (6 weeks)
Anthropometric measures
Periodo de tiempo: before and after experimental diet (high-protein, carbohydrate-reduced diet - 6 weeks) / before and after active comparator (Dutch Nutritional Guidelines - 6 weeks) / wash-out period in between (6 weeks)
Change in weight in kilograms
before and after experimental diet (high-protein, carbohydrate-reduced diet - 6 weeks) / before and after active comparator (Dutch Nutritional Guidelines - 6 weeks) / wash-out period in between (6 weeks)
Anthropometric measures II
Periodo de tiempo: before and after experimental diet (high-protein, carbohydrate-reduced diet - 6 weeks) / before and after active comparator (Dutch Nutritional Guidelines - 6 weeks) / wash-out period in between (6 weeks)
Change in Body Mass Index (BMI) in kilograms per square meter
before and after experimental diet (high-protein, carbohydrate-reduced diet - 6 weeks) / before and after active comparator (Dutch Nutritional Guidelines - 6 weeks) / wash-out period in between (6 weeks)
Body composition II
Periodo de tiempo: before and after experimental diet (high-protein, carbohydrate-reduced diet - 6 weeks) / before and after active comparator (Dutch Nutritional Guidelines - 6 weeks) / wash-out period in between (6 weeks)
change in fat and muscle mass measured by multi-frequency bio-electrical impedance analysis (BIA)
before and after experimental diet (high-protein, carbohydrate-reduced diet - 6 weeks) / before and after active comparator (Dutch Nutritional Guidelines - 6 weeks) / wash-out period in between (6 weeks)
Quality of life (QoL)
Periodo de tiempo: before and after experimental diet (high-protein, carbohydrate-reduced diet - 6 weeks) / before and after active comparator (Dutch Nutritional Guidelines - 6 weeks) / wash-out period in between (6 weeks)
change in QoL, 12-item short form health survey (SF-12)
before and after experimental diet (high-protein, carbohydrate-reduced diet - 6 weeks) / before and after active comparator (Dutch Nutritional Guidelines - 6 weeks) / wash-out period in between (6 weeks)
Fatigue
Periodo de tiempo: before and after experimental diet (high-protein, carbohydrate-reduced diet - 6 weeks) / before and after active comparator (Dutch Nutritional Guidelines - 6 weeks) / wash-out period in between (6 weeks)
change in fatigue (measured by Dutch Checklist Individual Strength (CIS-20) questionnaire)
before and after experimental diet (high-protein, carbohydrate-reduced diet - 6 weeks) / before and after active comparator (Dutch Nutritional Guidelines - 6 weeks) / wash-out period in between (6 weeks)
Physical functioning
Periodo de tiempo: before and after experimental diet (high-protein, carbohydrate-reduced diet - 6 weeks) / before and after active comparator (Dutch Nutritional Guidelines - 6 weeks) / wash-out period in between (6 weeks)
change in Hand Grip Strength (HSG)
before and after experimental diet (high-protein, carbohydrate-reduced diet - 6 weeks) / before and after active comparator (Dutch Nutritional Guidelines - 6 weeks) / wash-out period in between (6 weeks)
Physical functioning II
Periodo de tiempo: before and after experimental diet (high-protein, carbohydrate-reduced diet - 6 weeks) / before and after active comparator (Dutch Nutritional Guidelines - 6 weeks) / wash-out period in between (6 weeks)
change in the five time sit to stand (FTSTS) test
before and after experimental diet (high-protein, carbohydrate-reduced diet - 6 weeks) / before and after active comparator (Dutch Nutritional Guidelines - 6 weeks) / wash-out period in between (6 weeks)
Nutritional intake
Periodo de tiempo: before and after experimental diet (high-protein, carbohydrate-reduced diet - 6 weeks) / before and after active comparator (Dutch Nutritional Guidelines - 6 weeks) / wash-out period in between (6 weeks)
change in nutritional intake measured by a 3-day food diary
before and after experimental diet (high-protein, carbohydrate-reduced diet - 6 weeks) / before and after active comparator (Dutch Nutritional Guidelines - 6 weeks) / wash-out period in between (6 weeks)
Nutritional intake II
Periodo de tiempo: before and after experimental diet (high-protein, carbohydrate-reduced diet - 6 weeks) / before and after active comparator (Dutch Nutritional Guidelines - 6 weeks) / wash-out period in between (6 weeks)
change in nutritional intake measured by nutritional intake biomarkers from 24-hour urine measurements (sodium, potassium, and urea excretion for calculating the protein intake by use of the Maroni equation)
before and after experimental diet (high-protein, carbohydrate-reduced diet - 6 weeks) / before and after active comparator (Dutch Nutritional Guidelines - 6 weeks) / wash-out period in between (6 weeks)

Colaboradores e Investigadores

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

Patrocinador

University Medical Center Groningen

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 (Anticipado)

1 de enero de 2021

Finalización primaria (Anticipado)

1 de junio de 2022

Finalización del estudio (Anticipado)

1 de octubre de 2022

Fechas de registro del estudio

Enviado por primera vez

23 de diciembre de 2020

Primero enviado que cumplió con los criterios de control de calidad

5 de enero de 2021

Publicado por primera vez (Actual)

6 de enero de 2021

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

6 de enero de 2021

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

5 de enero de 2021

Última verificación

1 de enero de 2021

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • METc2020/050

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

Indeciso

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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