NCT06487832

Effect of GLP1 Receptor Agonist on Brain Insulin Responsiveness

Impact of the Incretin System on Brain Insulin Sensitivity in Humans with Normal Weight, Overweight and Obesity

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: University Hospital Tuebingen · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

Summary

The overarching goal of the current study is to investigate the effect of GLP-1 on brain insulin responsiveness in a randomized, single-blinded, within subject cross-over study design. To this end, investigators will compare the effect of the administration of semaglutide versus placebo, followed by an fMRI with administration of intranasal insulin or placebo.

Detailed description

Investigate the effect of the GLP1 receptor agonist (i.e. 0.25 mg semaglutide) vs. placebo on the brain using functional magnetic resonance imaging (fMRI) in combination with 160IU intranasal insulin vs. placebo administration in healthy male and female participants of normal-weight and overweight/obesity. Participants will furthermore undergo tasks that assess cognitive functions and eating behavior. Brain insulin responsiveness (primary outcome) is defined as the cerebral response to intranasal insulin compared to placebo by means of cerebral blood flow and resting-state BOLD measurements. Secondary outcomes include diffusion weighted imaging, neural food cue reactivity, cognitive functions and metabolic predictors.

Conditions

• Normal Weight
• Overweight and Obesity
• Insulin Sensitivity
• Insulin Resistance

Interventions

Type	Name	Description
OTHER	Subcutaneous GLP1-RA	Subcutaneous administration of semaglutide
OTHER	Subcutaneous placebo	Subcutaneous administration of NaCl

Timeline

• Start date: 2024-07-01
• Primary completion: 2027-07-31
• Completion: 2027-12-31
• First posted: 2024-07-05
• Last updated: 2025-03-30

Locations

1 site across 1 country: Germany