DRUG
Amylin (Pramlintide)
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
Status
Recruiting
Phase
Not applicable
Enrollment
18
Locations
1
Results
Not posted
Publications
0
Study summary
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.
Interventions
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
DRUG
This a one of the pancreatic hormones investigated in this study.
DRUG
This the placebo
Timeline
First posted
Apr 1, 2026
Study start
Apr 2026
Primary completion
Oct 2026
Study completion
Oct 2028
Results posted
Not reported
Registry updated
Apr 1, 2026
Outcomes
Food intake
Time frame · 300 to 330 minutes
Difference in food intake during an ad libitum meal. Food intake is examined as kalories (kcal) of food eaten during the ad libitum meal.
Composite appetite score
Time frame · -30 min to 330
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
Sensations of hunger, satiety, fullness, prospective food intake, nausea, thirst, comfort
Time frame · -30 to 330 minutes
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.
Eligibility
Inclusion Criteria: * Male * Age between 18 and 65 years at the time of inclusion * Body mass index 18-27 kg/m2 * Fat percentage \< 20% * Informed oral and written consent Exclusion Criteria: * Anaemia (haemoglobin below normal range) * History of hepatobiliary and/or gastrointestinal disorder(s) * Kidney disease * Previous gastric or intestinal resection, cholecystectomy and/or any major intra- abdominal surgery (including bariatric surgery) * Previous pancreatic disease and/or neoplasia * Regular tobacco smoking and/or use of other nicotine products * Glycated haemoglobin (HbA1c) ≥48 and/or type 1 diabetes or type 2 diabetes requiring medical treatment * Initiation of special diets, lifestyle changes and/or weight loss \>5% of total body weight within three months prior to or during study period * Any physical or psychological condition or ongoing medication the investigator group suspects would interfere with trial participation
Study locations
Denmark. Showing up to 24 locations stored in the fast local snapshot.
Center for Clinical Metabolic Research, Gentofte Hospital
Hellerup, Capital Region, Denmark
Publications
No PMID-linked publications were present in this registry snapshot.
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