Pancreatic Polypeptide as a Modulator of Amylin- Induced Satiety in Healthy Humans
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Amylin (Pramlintide), Pancreatic Polypeptide (PP), Placebo (NaCl 0.9 % solution).
- Who it may be relevant to
- Registry conditions: Obesity & Overweight. Basic parameters: 18 years — 65 years · Male.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Denmark
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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 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 - Drug Pancreatic Polypeptide (PP)
This a one of the pancreatic hormones investigated in this study. - Drug Placebo (NaCl 0.9 % solution)
This the placebo
Primary outcome measures
- Food intake [Time frame: 300 to 330 minutes]
Secondary outcome measures (2)
- Composite appetite score [Time frame: -30 min to 330]
- Sensations of hunger, satiety, fullness, prospective food intake, nausea, thirst, comfort [Time frame: -30 to 330 minutes]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Crossover
- Masking
- Double blind
- Primary purpose
- Basic science
Study locations
Denmark · 1 center
- Center for Clinical Metabolic Research, Gentofte Hospital — Hellerup
Identifiers
NCT: NCT07506369 · H-25083528