Insulin Sensitivity After Breast Cancer

NCT05010356 | Recruiting

• 1 other identifier: 514-0213/21-5000
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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 .

Conditions

Insulin Sensitivity/Resistance; Breast Cancer; Survivorship; Metabolic Disturbance

Outcome Measures

Primary Outcomes (2)

• Insulin sensitivity status

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

  2 years

• Hepatic glucose production

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

  2 years

Secondary Outcomes (2)

• Proteomic changes in skeletal muscle

  4 years

• Insulin signaling

  4 years

Study Arms (2)

Healthy control subjects

EXPERIMENTAL

Healthy control subjects undergoing a hyperinsulinemic euglycemic clamp

Drug: Insulin

Breast cancer survivors

EXPERIMENTAL

Breast cancer survivors undergoing a hyperinsulinemic euglycemic clamp

Drug: Insulin

Interventions

Insulin DRUG

Hyperinsulinemic euglycemic clamp

Also known as: Hyperinsulinemic euglycemic clamp

Breast cancer survivors; Healthy control subjects

Eligibility Criteria

• Age: 20 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Copenhagen: lead

Study Sites (1)

University of Copenhagen

Copenhagen, DK, 2100, Denmark

RECRUITING

MeSH Terms

Conditions

Insulin Resistance; Breast Neoplasms

Interventions

Insulin

Condition Hierarchy (Ancestors)

Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Proinsulin; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Lykke Sylow, PhD

  University of Copenhagen

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lykke Sylow, PhD

CONTACT

20955250; Lykkesylow@sund.ku.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: June 23, 2021
• First Posted: August 18, 2021
• Study Start: August 1, 2021
• Primary Completion: December 1, 2022
• Study Completion (Estimated): September 1, 2026
• Last Updated: August 18, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)