Insulin Receptor Substrate 1 (IRS-1) Regulation in Insulin Resistance

What Was Tested

This registered phase 1 trial tested Insulin (regular human) for insulin resistance, prediabetes & type 2 diabetes.

The study is being conducted to find out why too much fat in your blood stream may cause insulin resistance in your muscles.

Insulin is the hormone, produced normally by your body, which causes your blood sugar to return to normal after you eat.

It had three arms (groups): one (experimental), Overweight or Obese Subjects with Normal Glucose Tolerance (experimental) and Non-Obese Control Subjects (placebo comparator).

Two hours after the start of deuterated glucose, subjects will receive human insulin (U100 Humulin) at a rate of 80 mU/m\^2 surface area per minute one time over 4 hours.

Two hours after the start of deuterated glucose, subjects will receive human insulin (U100 Humulin) at a rate of 80 mU/m\^2 surface area per minute one time over 4 hours.

Two hours after the start of deuterated glucose, subjects will receive human insulin (U100 Humulin) at a rate of 80 mU/m\^2 surface area per minute one time over 4 hours.

The registry classes the interventions as drug.

More on the Plan

The aim of this study is to determine the extent to which the inflammatory response to lipids is present in naturally occurring insulin resistance.

The researchers will test the hypothesis that skeletal muscle from insulin resistant volunteers is characterized by: 1.

Changes in expression of proteasome genes.

The third group will consist of 15 age and gender matched nonobese control subjects (BMI \< 27).

Who Took Part

14 actual participants took part.

It was open to people of any sex aged from 30 years up to 65 years.

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

Examples of who could join: Age 30-65 y. Healthy lean, obese, or known type 2 diabetic. Body Mass Index (BMI) less than 36. All nondiabetic subjects must have normal oral glucose tolerance. Subjects must have the following laboratory values:.

The full record lists 13 inclusion and 4 exclusion criteria.

How the Study Was Run

The set-up was non-randomized, parallel-group and open-label.

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

Everyone knew when Insulin (regular human) was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

It started in 2012-03 with completion listed for 2012-07.

It ran at 1 site in United States.

Its stated primary purpose is basic science.

What Was Measured

Researchers chose this as the main measure: Proportion of insulin resistant patients with elevated serine/threonine phosphorylation of IRS-1 in muscle (time frame: one month from date of volunteer study).

It also tracked 1 secondary outcome, for example Quantitative assay of the ability of insulin to clear glucose from the blood in insulin resistant patients.

What This Means in Plain Language

Put simply, this is a phase 1, non-randomized trial of Insulin (regular human) in 14 people with insulin resistance, prediabetes & type 2 diabetes.

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

The trial is marked completed; 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.