Investigation of the Relationship Between Peripheral and Central Metabolic Changes Induced by GLP-1 Agonists

Sponsor
Nils Opel
Study ID
NCT06818292
Status
Completed

Conditions

  • Healthy

Eligibility Criteria

Sex
ALL
Age
18 Years - 43 Years
Healthy Volunteers
Accepted

Interventions

  • Liraglutide — BIOLOGICAL
    0.6 mg of the pre-filled solutions from pen-injector Liraglutide (GLP-1 Agonist)
  • Placebo — BIOLOGICAL
    0.1 mL NaCl

Study Details

This study aims to investigate the acute effects of Liraglutide, a GLP-1 receptor agonist established in the treatment of type 2 diabetes and obesity, on brain metabolism, brain network function, and executive functioning as well as mood in healthy, normal-weight individuals. Given the emerging evidence of GLP-1's impact on brain function, including the modulation of reward processing and cognitive functions, this study will focus on the physiological changes induced by Liraglutide and their potential implications for brain health. The overall goal of this study is to assess how acute GLP-1 administration influences systemic and brain metabolism to modulate brain signalling and behaviour.

Key Dates

Start date
Oct 21, 2024
Status verified
Feb 2025
Primary completion
Dec 6, 2024
Completion
Dec 6, 2024

Study Design

Enrollment
10 participants (actual)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: GLP-1 then Placebo
    Participants will be randomly assigned to receive equivalent volumes of either Placebo (NaCl) or 0.6 mg of the pre-filled solutions from pen-injector Liraglutide (GLP-1 Agonist) in a randomized, counterbalanced order. The administration will occur at two time points: T1 and T3 with a washout period of at least 1 day between the two interventions to minimize carryover effects.
  • Experimental: Placebo then GLP-1
    Participants will be randomly assigned to receive equivalent volumes of either Placebo (NaCl) or 0.6 mg of the pre-filled solutions from pen-injector Liraglutide (GLP-1 Agonist) in a randomized, counterbalanced order. The administration will occur at two time points: T1 and T3 with a washout period of at least 1 day between the two interventions to minimize carryover effects.

Primary Outcome Measure

Neuropsychology: Processing speed [ Time Frame: Outcome measures are assessed during a one-week on-site visit per participant (placebo vs. liraglutide days) within an overall study period of 2 months ]

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