Insulin Sensitivity After Breast Cancer

What Was Tested

The trial (not phased) is built around Insulin (regular human) for insulin resistance, prediabetes & type 2 diabetes.

Skeletal muscle is the major site of glucose uptake in humans.

It had two arms (groups): Healthy control subjects (experimental) and Breast cancer survivors (experimental).

Healthy control subjects undergoing a hyperinsulinemic euglycemic clamp.

Breast cancer survivors undergoing a hyperinsulinemic euglycemic clamp.

The registry classes the interventions as drug.

More on the Plan

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.

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.

Who Took Part

Enrollment: 24 planned participants were the target.

It was open to women only aged from 20 years up to 45 years.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: Premenopausal women operated for breast cancer and after completing adjuvant chemotherapy and no earlier than 3 weeks after its termination. Healthy controls will be included matched by gender, weight, age, and level of physical activity to the patient group included as subjects.

The full record lists 3 inclusion and 6 exclusion criteria; among the exclusions: known postmenopause occurred at the time of diagnosis of breast cancer; alcohol intake of\> 7 items / week; already known type 2 diabetes mellitus or metabolic syndrome and medical treatment thereof.

How the Study Was Run

It was run as a non-randomized, parallel-group and open-label study.

Groups ran in parallel: each of the insulin resistance, prediabetes & type 2 diabetes participants stayed in one arm throughout.

Being open-label, the Insulin (regular human) study did not mask who received what.

It started in 2021-08 with completion listed for 2022-12.

It ran at 1 site in Denmark.

Its stated primary purpose is basic science.

What Was Measured

Researchers chose this as the main measure: Insulin sensitivity status (time frame: 2 years). Hepatic glucose production (time frame: 2 years).

It also tracked 2 secondary outcomes, for example Proteomic changes in skeletal muscle and Insulin signaling.

What This Means in Plain Language

Put simply, this is a not phased, non-randomized trial of Insulin (regular human) in 24 people with insulin resistance, prediabetes & type 2 diabetes.

Its size is small, so on its own it can only give an early look.

Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Insulin (regular human) compound page, Insulin resistance, prediabetes & type 2 diabetes research.