Insulin Modulation of fMRI Connectivity in Healthy Adults

What Was Tested

In this early phase 1 trial, researchers set out to test Insulin (regular human).

This study evaluates the effects of changing insulin levels on brain activity.

Participants will complete functional magnetic resonance imaging (fMRI) scans during fasting conditions, then during an insulin infusion.

It had 1 arm (groups): Hyperinsulinemic Clamp (experimental).

The registry classes the interventions as drug and other.

More on the Plan

In addition to stimulating glucose uptake in the periphery, insulin signals the central nervous system to induce satiety and inhibit feeding behavior.

To begin to identify the specific effects of circulating insulin on brain networks, the current study will recruit healthy participants who will undergo two functional magnetic resonance imaging scans.

One scan will be performed in the fasted state, and the alternate scan will be conducted during an isoglycemic hyperinsulinemic clamp.

This project will allow them to identify the specific effects of circulating insulin on brain reactivity to palatable food.

Who Took Part

It was open to people of any sex aged from 21 years up to 30 years.

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

Examples of who could join: Body mass index between 18 and 24. HOMA-IR \< 1.55 (homeostatic model assessment of insulin resistance - ((glucose x insulin) / 405)).

The full record lists 2 inclusion and 28 exclusion criteria; among the exclusions: current or lifetime history of cancer, a chronic kidney or liver condition, type i or ii diabetes, or any pulmonary or respiratory disease; current or lifetime diagnoses of any substance abuse; positive urine drug screen.

How the Study Was Run

It was run as a single-group and open-label study.

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

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2016-01-01 with completion listed for 2017-12.

It ran at 1 site in United States.

Its stated primary purpose is basic science.

What Was Measured

The main thing measured (primary outcome): fMRI BOLD Response in Brain (time frame: During Taste Task in fMRI Scanner. Task Duration is approximately 14 minutes).

What This Means in Plain Language

Put simply, this is a early phase 1 trial of Insulin (regular human) in people.

It was withdrawn before enrolling anyone; no results are posted to the registry yet, so nothing here describes outcomes.

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