Health TrialsbyHealthPanel

Insulin Sensitivity After Breast Cancer

ConditionsInsulin Sensitivity/ResistanceBreast CancerSurvivorshipMetabolic Disturbance
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age20-45
SponsorUniversity of Copenhagen

About this trial

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 .

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Insulin

    Drug

    Hyperinsulinemic euglycemic clamp

Treatment groups

24 Participants
are divided into 2 treatment groups
Group A: Healthy control subjectsExperimental treatment 1 intervention
Group B: Breast cancer survivorsExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Insulin sensitivity status

Glucose infusion rate during the hyperinsulinemic euglycemic clamp to ascertain the insulin sensitivity

Time frame
2 years
2

Hepatic glucose production

Measurements from the Hyperinsulinemic Euglycemic Clamp will be used to assess insulin effects on hepatic glucose production

Time frame
2 years

Secondary outcomes

1

Proteomic changes in skeletal muscle

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

Time frame
4 years
2

Insulin signaling

Intracellular insulin signaling will be determined using western blotting technique

Time frame
4 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Copenhagen

Lead sponsor

Source ClinicalTrials.gov
Apply now