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The two pancreatic hormones amylin and pancreatic polypeptide (PP) has been linked to satiety and energy metabolism. The goal of this this study is to determine the separate and combined effects of the two hormones on food intake and other exploratory endpoints related to metabolism in healthy humans. The aim of this study is to investigate the interaction between the hormones and obtain insight into the physiology of the hormones.
The healthy participants will undergo 4 study days in a randomised order receiving the following infusions for 5 hours:
A) Amylin + PP B) Amylin + Placebo C) Placebo + PP D) Placebo + Placebo Throughout the day blood samples will be collected and gallbladder motility will be evaluated. Further, indirect calorimetry and heart rate/blood pressure measurement will be performed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Amylin (Pramlintide) + Placebo | Active Comparator |
| |
| PP + Placebo | Active Comparator |
| |
| Amylin (Pramlintide) + PP | Active Comparator |
| |
| Placebo + Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Amylin (Pramlintide) | Drug | This a one of the pancreatic hormones investigated in this study. Pramlintide is used a surrogate for amylin due to the fibrillating properties of amylin |
| Measure | Description | Time Frame |
|---|---|---|
| Food intake | Difference in food intake during an ad libitum meal. Food intake is examined as kalories (kcal) of food eaten during the ad libitum meal. | 300 to 330 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Composite appetite score | A score calculated from visual analog scales of hunger, fullness, and prospective food intake. The visual analog scale goes from 0 to 10 cm = from mimimum to maximum sensation | -30 min to 330 |
| Sensations of hunger, satiety, fullness, prospective food intake, nausea, thirst, comfort |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Andreas H Lange | Contact | +4553807019 | andreas.holst.lange@rehionh.dk |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Center for Clinical Metabolic Research, Gentofte Hospital | Recruiting | Hellerup | Capital Region | 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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| ID | Term |
|---|---|
| D058228 | Islet Amyloid Polypeptide |
| C105254 | pramlintide |
| D010191 | Pancreatic Polypeptide |
| D012996 | Solutions |
| ID | Term |
|---|---|
| D010187 | Pancreatic Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
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| Pancreatic Polypeptide (PP) | Drug | This a one of the pancreatic hormones investigated in this study. |
|
| Placebo (NaCl 0.9 % solution) | Drug | This the placebo |
|
The visual analog scale goes from 0 to 10 cm = from mimimum to maximum sensation. One questionnaire includes all the scales and assess all the mentioned sensations. |
| -30 to 330 minutes |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D058227 | Amyloidogenic Proteins |
| D000682 | Amyloid |
| D011506 | Proteins |
| D009479 | Neuropeptides |
| D009419 | Nerve Tissue Proteins |
| D004364 | Pharmaceutical Preparations |