Effect of GLP1 Receptor Agonist on Brain Insulin Responsiveness
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorUniversity Hospital Tuebingen
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
BMI between 18.5 and 24.9 kg/m2; and between 27.5 kg/m2 and 40 kg/m2
Written consent to participate in the study
Written consent to be informed about incidental findings
Disqualifiers
Type 1 or type 2 diabetes, LADA, MODY, or cardiovascular diseases such as chronic heart failure, myocardial infarction, status post stroke
BMI < 18.5 or > 40 kg/m2
Persons who cannot legally give consent
Pregnancy or lactation
Trial design
Design model
Crossover
Treatments tested in this trial
Subcutaneous GLP1-RA
Other interventionSubcutaneous administration of semaglutide
Subcutaneous placebo
Other interventionSubcutaneous administration of NaCl
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: GLP-1Experimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Cerebral response after insulin compared to placebo nasal spray
Resting-state cerebral blood flow and BOLD-fMRI response from before to 30 min after nasal spray administration
Time frame
24 hours after semaglutide or placebo administrationSecondary outcomes
1
Neural food-cue reactivity after insulin compared to placebo nasal spray
BOLD-fMRI response to food cues 30 min after nasal spray administration
Time frame
24 hours after semaglutide or placebo administration2
Diffusion-weighted imaging (DWI)
Diffusion weighted parameter based on MRI measurements
Time frame
24 hours after semaglutide or placebo administration3
Heart rate variability (HRV)
HRV based on ECG measurements
Time frame
24 hours after semaglutide or placebo administration4
Change in subjective feeling of hunger and food craving
On a visual analogue scale, subjective feeling of hunger and food craving will be assessed using questionnaires.
Time frame
24 hours after semaglutide or placebo administrationSponsors and contacts
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Source ClinicalTrials.gov