A Novel Positron Emission Tomography (PET) Approach to Measuring Myocardial Metabolism

What Was Tested

This registered not phased trial tested Insulin (regular human).

Studies of myocardial fuel selection using a novel palmitate-based PET probe.

It had two arms (groups): Saline (experimental) and Insulin Clamp (experimental).

Studies will be performed on one day under fasting conditions, using a saline infusion. All subjects will receive infusions of radiolabeled acetate and radiolabeled thiapalmitate tracer (16-18-F-fluoro-4-thiapalmitate).

Studies will be performed on a separate day under fasting conditions, using an insulin infusion to achieve steady state insulin/glucose clamp conditions. Studies will be performed on one day under fasting conditions, using a saline infusion. All subjects will receive infusions of radiolabeled acetate and radiolabeled thiapalmitate tracer (16-18-F-fluoro-4-thiapalmitate).

The registry classes the interventions as drug.

More on the Plan

A novel Positron Emission Tomography (PET) probe, 16- 18-F-fluoro-4-thiapalmitate, will be used to evaluate myocardial atty acid uptake.

Studies will take place on 2 separate days, under fasting conditions and under insulin clamp conditions.

Who Took Part

18 actual participants took part.

It was open to people of any sex aged from 18 years up to 45 years.

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

Examples of who could join: BMI \>25 kg/m2. On oral and/or injected insulin treatment.

The full record lists 7 inclusion and 5 exclusion criteria; among the exclusions: known microvascular disease; known coronary or other macro vascular disease; use of ppargamma class antidiabetic agents within 6 months.

How the Study Was Run

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

In the crossover set-up each of the participants took both Insulin (regular human) and the comparison in turn, acting as their own control.

Nothing was hidden in this open-label Insulin (regular human) study: the participants and staff both knew the treatment.

It started in 2007-01 with completion listed for 2009-06.

It ran at 1 site in United States.

Its stated primary purpose is basic science.

What Was Measured

The main thing measured (primary outcome): Myocardial Fatty Acid Uptake Rate (time frame: 4 Hours).

It also tracked 2 secondary outcomes, for example Myocardial Oxidation Rate and Myocardial Perfusion Rate.

What This Means in Plain Language

Put simply, this is a not phased, non-randomized trial of Insulin (regular human) in 18 people.

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

The trial is marked completed; results are posted on the registry, and this page does not restate them.

More context: the Insulin (regular human) compound page, all human trials.