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Pancreatic Polypeptide as a Modulator of Amylin- Induced Satiety in Healthy Humans

RecruitingNAAges 18 Years - 65 YearsMaleUniversity Hospital, Gentofte, Copenhagen
NCT07506369 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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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📋 Eligibility rules (as published)
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
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What it tests

  • Amylin (Pramlintide)
  • Pancreatic Polypeptide (PP)
  • Placebo (NaCl 0.9 % solution)
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Where

1 site
Center for Clinical Metabolic Research, Gentofte Hospital
Hellerup, Denmark
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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