- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT05010356
Insulin Sensitivity After Breast Cancer
Study of Molecular Causes of Metabolic Disorders in Obese Premenopausal Women After Breast Cancer
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Up to 80% of women with breast cancer (BC) develop metabolic disorders, such as insulin resistance, obesity, hyperinsulinemia, and glucose intolerance, during or after their treatment. Such disorders increase BC mortality and the likelihood of relapse 2- and 3-fold, respectively. However, it is not known why BC and/or the treatment hereof causes metabolic disorders and very few studies have investigated the underlying biological causes.
Aims:
- determine the involvement of insulin resistance in skeletal muscle in the metabolic disorders prevalent in BC survivors
- identify BC-and/or treatment-induced molecular changes in skeletal muscle
BC is a common cancer with 2.1 million new cases each year, and BC also causes the largest number of cancer-related deaths among women worldwide. Fortunately, more people are now surviving their cancer. In Denmark, the majority of the 300.000 cancer survivors, constitute a group of ~ 70,000 women who have survived BC. However, there is a severe lack of research into the physiological sequelae of cancer and/or treatment, including the metabolic health consequences of BC. Recent epidemiological studies have revealed that 60-80% of women with BC develop metabolic disorders that are similar to those observed in conditions such as type 2 diabetes (T2D) during or following their treatment. However, unlike T2D, the underlying biological causes for the development of metabolic disorders with BC and/or the treatment are poorly investigated. It is important to address this knowledge gap, as metabolic disorders increase mortality among women with BC 2-fold and increase the likelihood of BC recurrence up to 3-fold.
The investigators hypothesize that metabolic disorders in BC survivors are due to cancer and/or treatment-mediated molecular rewiring of skeletal muscle, which causes insulin resistance.
Scientific breakthroughs in obesity and diabetes research have shown that hyperinsulinemia and hyperglycemia are most often caused by insulin resistance in skeletal muscle, fat, and liver. In particular, skeletal muscle is essential for maintaining a normal metabolism as it is responsible for up to 75% of the uptake of glucose from the blood in response to insulin. It is thus likely that skeletal muscle insulin resistance causes metabolic perturbations in BC survivors but this has not been investigated directly. Insulin-resistant skeletal muscle does not respond normally to insulin, causing severe metabolic disorders. These include hyperglycemia, hyperinsulinemia, dyslipidemia and hypertension; all conditions that are increasingly being documented in women with BC and BC survivors It is likely that insulin resistance in skeletal muscle is causing the metabolic disorders often present in BC survivors. Since muscle plays key roles in metabolic regulation by keeping blood glucose and insulin levels normal, it is extremely relevant to clarify the precise involvement of skeletal muscle in BC-related metabolic disorders.
12 premenopausal women (Body Mass Index = 25-30) who were operated for BC (stage I-III) will be included. Especially overweight premenopausal women develop markedly metabolic dysfunction as determined by an oral glucose tolerance test. The subjects will be studied 3-10 weeks after completing adjuvant chemotherapy. Twelve healthy weight-, activity- and age-matched subjects will be recruited as controls (matched by bicycle exercise test, grip strength, dual x-ray absorptiometry, and using the international physical activity questionnaire). Exclusion criteria are as follows: Post-menopause at the time of BC diagnosis, metastatic cancer, < 4 or > 5 series of paclitaxel treatment, alcohol intake of > 7 items/week, smoking, known T2D or metabolic syndrome, known cardiovascular disease and medical treatment thereof, or impaired mobility. Insulin sensitivity will be measured via the hyperinsulinemic-euglycemic clamp method. In short, basal muscle (from the vastus lateralus muscle) biopsies are taken after 1 hour rest after which insulin (1.4 mU/kg/min) is administered while maintaining euglycemia by continuous glucose infusion. Insulin-stimulated biopsies are taken after 1.5 hours.
Tipo de estudio
Inscripción (Anticipado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Lykke Sylow, PhD
- Número de teléfono: 20955250
- Correo electrónico: Lykkesylow@sund.ku.dk
Ubicaciones de estudio
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DK
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Copenhagen, DK, Dinamarca, 2100
- Reclutamiento
- University of Copenhagen
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Contacto:
- Lykke Sylow, PhD
- Número de teléfono: 0045 20955250
- Correo electrónico: Lykkesylow@sund.ku.dk
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Premenopausal women operated for breast cancer and after completing adjuvant chemotherapy and no earlier than 3 weeks after its termination
- BMI: 25-30
- Healthy controls will be included matched by gender, weight, age, and level of physical activity to the patient group included as subjects
Exclusion Criteria:
- Known postmenopause occurred at the time of diagnosis of breast cancer
- Alcohol intake of> 7 items / week
- Smoker
- Already known Type 2 diabetes mellitus or metabolic syndrome and medical treatment thereof.
- Cardiovascular disease and its medical treatment
- Impaired mobility
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Ciencia básica
- Asignación: No aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: Healthy control subjects
Healthy control subjects undergoing a hyperinsulinemic euglycemic clamp
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Hyperinsulinemic euglycemic clamp
Otros nombres:
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Experimental: Breast cancer survivors
Breast cancer survivors undergoing a hyperinsulinemic euglycemic clamp
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Hyperinsulinemic euglycemic clamp
Otros nombres:
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Insulin sensitivity status
Periodo de tiempo: 2 years
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Glucose infusion rate during the hyperinsulinemic euglycemic clamp to ascertain the insulin sensitivity
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2 years
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Hepatic glucose production
Periodo de tiempo: 2 years
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Measurements from the Hyperinsulinemic Euglycemic Clamp will be used to assess insulin effects on hepatic glucose production
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2 years
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Proteomic changes in skeletal muscle
Periodo de tiempo: 4 years
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Skeletal muscle biopsies from the vastus lateralis muscle will be analysez using mass spectometry to determine proteomic chances in response to breast cancer in skeletal muscle
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4 years
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Insulin signaling
Periodo de tiempo: 4 years
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Intracellular insulin signaling will be determined using western blotting technique
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4 years
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Lykke Sylow, PhD, University of Copenhagen
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Anticipado)
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
- Trastornos del metabolismo de la glucosa
- Enfermedades metabólicas
- Enfermedades de la piel
- Enfermedades del sistema inmunológico
- Neoplasias
- Neoplasias por sitio
- Enfermedades de los senos
- Hiperinsulinismo
- Hipersensibilidad
- Neoplasias de mama
- Resistencia a la insulina
- Agentes hipoglucemiantes
- Efectos fisiológicos de las drogas
- Insulina
Otros números de identificación del estudio
- 514-0213/21-5000
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (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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