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Insulin Sensitivity After Breast Cancer

10 de agosto de 2021 atualizado por: Lykke Sylow, University of Copenhagen

Study of Molecular Causes of Metabolic Disorders in Obese Premenopausal Women After Breast Cancer

Epidemiological studies have revealed that 60-80% of women with breast cancer (BC) develop metabolic disorders that are similar to those observed in conditions like type 2 diabetes. These metabolic disorders, including insulin resistance, obesity, hyperinsulinemia, and glucose intolerance, are associated with increased BC recurrence and mortality. Skeletal muscle is the major site of glucose uptake in humans. The aims of the present project are to 1) determine the involvement of insulin resistance in skeletal muscle in the metabolic disorders prevalent in BC survivors, 2) identify BC-and/or treatment-induced molecular changes in skeletal muscle from BC survivors .

Visão geral do estudo

Descrição detalhada

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:

  1. determine the involvement of insulin resistance in skeletal muscle in the metabolic disorders prevalent in BC survivors
  2. 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 estudo

Intervencional

Inscrição (Antecipado)

24

Estágio

  • Não aplicável

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

Locais de estudo

    • DK
      • Copenhagen, DK, Dinamarca, 2100
        • Recrutamento
        • University of Copenhagen
        • Contato:

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

20 anos a 45 anos (Adulto)

Aceita Voluntários Saudáveis

Sim

Gêneros Elegíveis para o Estudo

Fêmea

Descrição

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

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Ciência básica
  • Alocação: Não randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Nenhum (rótulo aberto)

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: Healthy control subjects
Healthy control subjects undergoing a hyperinsulinemic euglycemic clamp
Hyperinsulinemic euglycemic clamp
Outros nomes:
  • Hyperinsulinemic euglycemic clamp
Experimental: Breast cancer survivors
Breast cancer survivors undergoing a hyperinsulinemic euglycemic clamp
Hyperinsulinemic euglycemic clamp
Outros nomes:
  • Hyperinsulinemic euglycemic clamp

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Insulin sensitivity status
Prazo: 2 years
Glucose infusion rate during the hyperinsulinemic euglycemic clamp to ascertain the insulin sensitivity
2 years
Hepatic glucose production
Prazo: 2 years
Measurements from the Hyperinsulinemic Euglycemic Clamp will be used to assess insulin effects on hepatic glucose production
2 years

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Proteomic changes in skeletal muscle
Prazo: 4 years
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
4 years
Insulin signaling
Prazo: 4 years
Intracellular insulin signaling will be determined using western blotting technique
4 years

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Investigadores

  • Investigador principal: Lykke Sylow, PhD, University of Copenhagen

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Antecipado)

1 de agosto de 2021

Conclusão Primária (Antecipado)

1 de dezembro de 2022

Conclusão do estudo (Antecipado)

1 de setembro de 2026

Datas de inscrição no estudo

Enviado pela primeira vez

23 de junho de 2021

Enviado pela primeira vez que atendeu aos critérios de CQ

10 de agosto de 2021

Primeira postagem (Real)

18 de agosto de 2021

Atualizações de registro de estudo

Última Atualização Postada (Real)

18 de agosto de 2021

Última atualização enviada que atendeu aos critérios de controle de qualidade

10 de agosto de 2021

Última verificação

1 de agosto de 2021

Mais Informações

Termos relacionados a este estudo

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

NÃO

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

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