A Study of the Functional Magnetic Resonance Imaging Response to Leptin and Pramlintide

What Was Tested

In this not phased trial, researchers set out to test Amylin (Islet Amyloid Polypeptide).

The purpose of this study is to identify how certain parts of the brain that help control body weight respond to an infusion of hormones called leptin and amylin.

It had four arms (groups): 1- Normal Saline (placebo comparator), 2 Metreleptin (active comparator), 3 Pramlintide (active comparator) and 4 Leptin plus Pramlintide (active comparator).

4.7 mls normal saline IV bolus.

IV Leptin bolus.

IV Pramlintide bolus at Timpoint +0 and +30 minutes.

The registry classes the interventions as drug.

More on the Plan

Following an overnight fast, subjects will undergo fMRI measurements of the hypothalamus, brainstem and whole brain during an infusion of either normal saline, pramlintide, leptin, or the combination leptin and pramlintide.

Who Took Part

The registry lists 10 planned participants were the target.

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: Age 18 year to 45 years of age. MI 18 to 25 kg/m2 or ≥ 30 kg/m2. At maximal lifetime weight. Weight stable for at least 3 months.

The full record lists 4 inclusion and 19 exclusion criteria; among the exclusions: those with a major medical illness or who require prescription medication, including: cancer, coronary artery disease, hypertension, and diabetes; subjects taking psychiatric or centrally-acting (cns) medications or who are diagnosed with a psychiatric or neurological illness, including:; seizure disorder.

How the Study Was Run

The set-up was randomized, crossover and triple-blind.

The participants were allocated by chance, so the Amylin (Islet Amyloid Polypeptide) group and the comparison group should start out alike.

In the crossover set-up each of the participants took both Amylin (Islet Amyloid Polypeptide) and the comparison in turn, acting as their own control.

Blinding on both sides kept the participants and researchers unaware of who received Amylin (Islet Amyloid Polypeptide).

Those kept unaware of assignments: participant, investigator and outcomes assessor.

It started in 2006-01 with completion listed for 2024-07.

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: To measure the fMRI response in the hypothalamus and brainstem, and whole brain, to intravenous leptin, pramlintide, combination leptin and pramlintide, and saline control (time frame: over 90 minutes).

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Amylin (Islet Amyloid Polypeptide) in 10 people.

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 Amylin (Islet Amyloid Polypeptide) compound page, all human trials.