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| ID | Type | Description | Link |
|---|---|---|---|
| NNF23OC0084114 | Other Grant/Funding Number | Novo Nordisk Foundation |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LEAP2 infusion | Active Comparator |
| |
| Placebo infusion | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LEAP2 infusion | Other | The LEAP2 infusion is a hormone infusion that is different from the placebo (saline) infusion |
|
| Measure | Description | Time Frame |
|---|---|---|
| Difference in food cue reactivity between experimental days | 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. | time 75 - 135 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Difference in appetite ratings | Difference in visual Analogue Scales (VASs) assessing appetite, satiety, and hunger sensations. | From baseline to end of infusion |
| Changes in peptide hormone concentrations |
| Measure | Description | Time Frame |
|---|---|---|
| Reactivity from Negative Emoition Reactivity Test (NERT) | Change in BOLD signals when viewing pictures of that could cause stress (Negative Emoition Reactivity Test (NERT)). Differences will be compared between the two experimental days with infusion of placebo and LEAP2, respectively. | time 75 - 135 minutes |
| Plasma glucose |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Center for Clinical Metabolic Research | Hellerup | 2900 | Denmark |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D050177 | Overweight |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
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| Placebo | Other | Placebo infusion (saline) is different from the LEAP2 infusion |
|
Plasma/serum concentrations of LEAP2, growth hormone as well as other glucose- and appetite-regulating gut hormones
| From baseline to end of infusion |
Change in plasma glucose concentration during the experimental days |
| Through experimental day. From timepoints -15 to 135 min |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |