Clinical trial

Effects of Antagonizing the Ghrelin Receptor on Brain Food Cue Reactivity in Obesity

Active, not recruiting · Not applicable · 1 countries · Registry ID NCT06845033

Active, not recruitingNot applicableInterventional

What this study is about

The naturally occurring peptide hormone liver-expressed antimicrobial peptide 2 (LEAP2) in an antagonist/inverse agonist towards the ghrelin receptor. Ghrelin administration has previously been shown to increase food cue reactivity in brain regions related to appetite and reward using functional MRI scans. The aim of this clinical study is to investigate the effects of LEAP2 infusion on food cue reactivity in brain regions related to appetite and reward. Since LEAP2 is an antagonist/inverse agonist towards the ghrelin receptor we hypothesize, that LEAP2 infusion will decrease food cue reactivity in the above-mentioned regions compared to placebo infusion. Participants with obesity (BMI 30-50 kg/m2) will be included and complete two experimental days with either LEAP2 or placebo infusion in a randomized crossover manner. On experimental days, participants will undergo a MRI scan with functional and anatomical modalities. The study will attribute to gain a deeper understanding of the ghrelin system and its interaction with appetite regulation.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to 60 Years

SexMale

Healthy volunteersNot accepted

ConditionObesity and Overweight

Full registry criteria

Inclusion Criteria: * Age between 18 and 60 years at the time of inclusion * Body mass index 30-50 kg/m2 * Men * Informed consent Exclusion Criteria: * Anaemia (haemoglobin below normal range) * Alanine aminotransferase (ALAT) and/or aspartate aminotransferase (ASAT) \>2 times normal values) or present hepatobiliary and/or gastrointestinal disorder(s) * Nephropathy (serum creatinine above normal range and/or albuminuria) * Glycated haemoglobin (HbA1c) ≥48 mmol/mol and/or type 2 diabetes requiring medical treatment * Regular tobacco smoking or use of other nicotine-containing products * Claustrophobia * Any ongoing medication that the investigator evaluates would interfere with trial participation. * Any physical or psychological condition that the investigator evaluates would interfere with trial participation including any acute or chronic illnesses

Treatments and study arms

LEAP2 infusion

Other

The LEAP2 infusion is a hormone infusion that is different from the placebo (saline) infusion

Placebo

Other

Placebo infusion (saline) is different from the LEAP2 infusion

Primary outcomes

Difference in food cue reactivity between experimental daystime 75 - 135 minutes

The primary endpoint is the change in BOLD signals when viewing pictures of food vs. non-food. Differences will be compared between the two experimental days with infusion of placebo and LEAP2, respectively.

Study locations

1 locations were listed when this page was built. The first 40 are shown.

Center for Clinical Metabolic Research🇩🇰 Hellerup, Denmark

Open map