Effects of Liraglutide on Hippocampal Structure and Function in Aging Adults With Prediabetes

What Was Tested

In this phase 1 trial, researchers set out to test Liraglutide for insulin resistance, prediabetes & type 2 diabetes.

The purpose of this study is to evaluate the effects of liraglutide on the memory and attention of people with insulin resistance.

It had two arms (groups): Liraglutide (active comparator) and Placebo (placebo comparator).

The registry classes the interventions as drug.

More on the Plan

Data from this study will be used to measure changes in hippocampal morphology, functional alterations in the hippocampus during a paired associative memory task, functional connectivity during rest, and neuropsychological performance on hippocampally-mediated cognitive tasks, following double-blind treatment with liraglutide and placebo.

Study Procedures The study will be explained to the participant and informed consent obtained.

Participant will also be asked whether or not they consent to being videotaped during the study, and if they do, parts of their study participation may be videotaped for staff training purposes.

Participants will continue any current psychiatric medication(s) or psychotherapy during the duration of the study (eg. no changes will be made to currently received treatments).

Who Took Part

Enrollment: 41 actual participants took part.

It was open to people of any sex aged from 50 years up to 70 years.

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

Examples of who could join: Also, half of all subjects will have a family history of dementia.

The full record lists 4 inclusion and 8 exclusion criteria; among the exclusions: presence of medications known to affect insulin action or insulin secretion; participants with history of mood disorder must be in remission for at least 6 months prior to study entry.

How the Study Was Run

Design: randomized, parallel-group and triple-blind.

Because people in this Liraglutide study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

The Liraglutide group and the comparison group ran side by side rather than switching.

As a double-blind Liraglutide study, the assignments were hidden from both participants and investigators until the end.

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

It started in 2013-08 with completion listed for 2017-02.

It ran at 1 site in United States.

Its stated primary purpose is other.

What Was Measured

Primary outcome: Cognitive Outcomes (time frame: Change from Baseline to 3 months). OGTT (time frame: Change from Baseline to 3 months).

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Liraglutide in 41 people with insulin resistance, prediabetes & type 2 diabetes.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Liraglutide compound page, Insulin resistance, prediabetes & type 2 diabetes research.