Obesity and Overweight
Conditions
Brief summary
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.
Interventions
OTHERLEAP2 infusion
The LEAP2 infusion is a hormone infusion that is different from the placebo (saline) infusion
OTHERPlacebo
Placebo infusion (saline) is different from the LEAP2 infusion
Sponsors
University Hospital, Gentofte, Copenhagen
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
18 Years to 60 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Difference in food cue reactivity between experimental days | time 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Difference in appetite ratings | From baseline to end of infusion | Difference in visual Analogue Scales (VASs) assessing appetite, satiety, and hunger sensations. |
| Changes in peptide hormone concentrations | From baseline to end of infusion | Plasma/serum concentrations of LEAP2, growth hormone as well as other glucose- and appetite-regulating gut hormones |
Countries
Denmark
Outcome results
None listed