drugset / Trial / NCT05553405

Neuroimmune Mechanisms in Obesity

NCT05553405

Phase 1 Withdrawn Yale University
Non-randomizedParallel-groupOpen-labelBasic science

Summary

Aim 1: To measure levels of microglia using the radiotracer \[11C\]PBR28 and PET brain imaging in obese (n=50) vs. lean individuals (n=50). The investigators will recruit 100 subjects who will participate in a single \[11C\]PBR28 scan to measure levels of TSPO, a marker of microglia. Aim 2: To determine differences in brain functional connectivity at rest and in response to a decision- making task in obese (n=50) vs. lean individuals (n=50) using fMRI imaging. The same subjects from Aim 1 will participate in a resting state functional magnetic resonance imaging (fMRI) followed by a decision making task during fMRI acquisition. Aim 3: To assess whether acute elevation of lipid levels through intralipid infusion in lean, healthy individuals (n=20) will induce microglial activation. 20 lean individuals will be recruited to participate in a paradigm that includes a baseline \[11C\]PBR28 scan, an infusion of intralipid, and a second \[11C\]PBR28 scan approximately 4 hours post intralipid infusion. The investigators will attempt to utilize subjects from aim 1 in order to use their baseline scans for this paradigm. Aim 4: To determine whether there are differences in levels of microglia between individuals with and without type 1 diabetes (n=20). 20 patients with diabetes (type 1 diabetes or type 2 diabetes)will be recruited to participate in a single \[11C\]PBR28 scan to compare to Aim 1 participants.

Timeline

Start
2024-01-01
Primary completion
2033-01-01
Completion
2033-01-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Intralipid Other / unclassified 20 % Intravenous

Indications