Plasma Triglyceride Extraction by The Muscle

What Was Tested

The trial (phase 1) is built around Insulin (regular human) for insulin resistance, prediabetes & type 2 diabetes.

The purpose of this research is to find out how fat circulating in the blood following fat consumption is taken up by the muscles in healthy people as well as people that are insulin-resistant.

The investigators are specifically interested in how a hormone called insulin is involved in this process.

It had two arms (groups): Insulin-Sensitive (experimental) and Insulin-Resistant (experimental).

One group consists of insulin sensitive volunteers.

One group consists of insulin resistant volunteers.

The registry classes the interventions as drug.

Who Took Part

Enrollment: 33 actual participants took part.

It was open to people of any sex aged from 18 years up to 50 years.

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

Examples of who could join: Body mass index (BMI): \< 25 kg/m2 or \> 30 kg/m2;. Insulin sensitivity index (ISI): insulin-sensitive ISI ≥ 7, insulin-resistant ISI ≤ 5.

The full record lists 2 inclusion and 13 exclusion criteria; among the exclusions: medication or supplements known to affect either endothelial function or lipid metabolism (i.e. arginine, protein, fish oil); acute illness; uncontrolled metabolic disease, including liver or renal disease.

How the Study Was Run

The set-up was non-randomized, parallel-group and single-blind.

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

Only one side, usually the insulin resistance, prediabetes & type 2 diabetes participants, was kept unaware of whether Insulin (regular human) was given.

Those kept unaware of assignments: participant.

It started in 2013-04 with completion listed for 2016-08-31.

It ran at 1 site in United States.

Its stated primary purpose is basic science.

What Was Measured

Primary outcome: Triglyceride extraction across the forearm (time frame: Measured during a 7-hour infusion study).

It also tracked 1 secondary outcome, for example Muscle microvascular blood volume.

What This Means in Plain Language

Put simply, this is a phase 1, non-randomized trial of Insulin (regular human) in 33 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.