Moderate or Extensive Carbohydrate Reduction in Risk Patients (LOWinCHIP)
To Lower Glucose Levels and Reduce Weight by Exclusion of Carbohydrates and Inclusion of Psychological Behavioral Support
Risk-patients for diabetes or patients that are diagnosed with this condition but who are not treated with insulin are randomized two times, according to diet and according to the type of support:
Randomization with regard to carbohydrate restriction (25-30 E% or < 10E%). Randomization with regard to type of psychological support. Either according to Acceptance and Commitment Therapy or to traditional cognitive behavioral therapy. Both kinds of psychological support is given as group therapy.
Two-hundred patients are recruited and each patient is followed for two years.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
The organizers will recruit 200 patients in the study "To lower glucose levels and reduce weight by exclusion of carbohydrates and inclusion of psychological behavioral support" (LOWinCHIP) at the primary care health center "Cithyhälsan Centrum" in Norrköping. Each patient will be followed for 2 years. Patients are eligible if they have are above 18 years of age and have a BMI above 28 kg/m2 and also belong to one or more of the following groups: 1) type 2 diabetes that is not treated with insulin. 2) Patients that have had gestational diabetes or who have 3) first grade relative with type 2 diabetes. Finally 4) pre-diabetic individuals with impaired fasting glucose (6.1-6.9 mmol) or impaired glucose tolerance (capillary plasma glucose 8.9-12-1 after glucose challenge) are also potential participants. Patients must not have insulin therapy or severe kidney failure (GFR< 30). They can also not have severe physical restrictions for activity and they must not have difficulties with understanding written Swedish texts.
The participants are randomized two times (two by two factorial):
Randomization with regard to carbohydrate restriction (25-30 E% or < 10E%). Randomization with regard to type of psychological support. Either according to Acceptance and Commitment Therapy (ACT) or to traditional cognitive behavioral therapy. Each group will have three group sessions with approximately 8 participants followed by a telephone call by the therapist. Each session will be held by the psychologists that are part of the Cityhälsan Centrum staff.
The study has > 95% power to demonstrate 5% HbA1c (mmol/mol) difference between groups with a drop out of 25%.
Tipo de estudio
Inscripción (Anticipado)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
-
Linkoping, Suecia, 58185
- Reclutamiento
- University Hospital of Linkoping
-
Contacto:
- Fredrik H Nystrom, MD, prof.
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Investigador principal:
- Fredrik H Nystrom, MD PhD prof
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Diabetes without insulin. Patients at high risk for developing diabetes.
Exclusion Criteria:
- Severe kidney failure. Insulin therapy. Inability to understand instructions.
Plan de estudios
¿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 |
|---|---|
|
Comparador activo: Moderate carbohydrate restriction and traditional support
Moderate carbohydrate restriction and traditional support with group meetings
|
Randomization to moderate or extreme low-carbohydrate Mediterranean diet advice.
Randomization to group-based psychological support according to ACT or to traditional cognitive behavioral therapy
|
|
Comparador activo: Extreme low carbohydrate diet and traditional support
Extreme carbohydrate restriction and traditional support with group meetings
|
Randomization to moderate or extreme low-carbohydrate Mediterranean diet advice.
Randomization to group-based psychological support according to ACT or to traditional cognitive behavioral therapy
|
|
Comparador activo: Moderate carbohydrate restriction and ACT support
Moderate carbohydrate restriction and psychological support based on acceptance and commitment therapy
|
Randomization to moderate or extreme low-carbohydrate Mediterranean diet advice.
Randomization to group-based psychological support according to ACT or to traditional cognitive behavioral therapy
|
|
Comparador activo: Extreme carbohydrate restriction and ACT support
Extreme carbohydrate restriction and psychological support based on acceptance and commitment therapy
|
Randomization to moderate or extreme low-carbohydrate Mediterranean diet advice.
Randomization to group-based psychological support according to ACT or to traditional cognitive behavioral therapy
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Long-term glucose levels
Periodo de tiempo: 2 years
|
HbA1c levels
|
2 years
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Quality of Life
Periodo de tiempo: 2 years
|
Quality of Life by questionnaires
|
2 years
|
|
Cardiovascular risk factors
Periodo de tiempo: 2 years
|
Lipids, body weight, glucose, ketones
|
2 years
|
Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Anticipado)
Finalización del estudio (Anticipado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- LOWinCHIP
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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