NCT05553405

Neuroimmune Mechanisms in Obesity

• Status: Withdrawn
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Yale University · Academic / Other
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Conditions

• Obesity

Interventions

Type	Name	Description
DRUG	Intralipid Infusion	Intralipid 20% (a 20% IV fat emulsion) is a sterile, non-pyrogenic fat emulsion prepared for IV administration as a source of calories and essential fatty acids. It is made up of 20% soybean oil, 1.2% egg yolk phospholipids, 2.25% glycerin and water for injection. In addition, sodium hydroxide has been added to adjust the pH so that the final product pH is 8.

Timeline

• Start date: 2024-01-01
• Primary completion: 2033-01-01
• Completion: 2033-01-01
• First posted: 2022-09-23
• Last updated: 2023-06-18

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study