How pancreatic polypeptide affects amylin-driven fullness in healthy adults
Pancreatic Polypeptide as a Modulator of Amylin- Induced Satiety in Healthy Humans
NA · University Hospital, Gentofte, Copenhagen · NCT07506369
This test will see if giving pancreatic polypeptide together with amylin changes feelings of fullness and how much healthy adults eat.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 18 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | Male |
| Sponsor | University Hospital, Gentofte, Copenhagen (other) |
| Locations | 1 site (Hellerup, Capital Region) |
| Trial ID | NCT07506369 on ClinicalTrials.gov |
What this trial studies
Healthy male volunteers receive four different five-hour infusions on separate randomized study days: amylin plus pancreatic polypeptide, amylin plus placebo, pancreatic polypeptide plus placebo, and placebo plus placebo. Throughout each study day investigators collect blood samples, measure gallbladder motility, record heart rate and blood pressure, and perform indirect calorimetry to track metabolic effects. The crossover design allows within-person comparison of the separate and combined hormone effects on food intake and related metabolic endpoints. Results will help clarify how these pancreatic hormones interact to control satiety and energy metabolism.
Who should consider this trial
Good fit: Healthy men aged 18–65 years with BMI 18–27 kg/m2, body fat under 20%, no major gastrointestinal, hepatic, renal, or pancreatic disease, non-smokers, and able to give informed consent are ideal candidates.
Not a fit: People outside the trial profile—including women, those with higher BMI or obesity, diabetes requiring treatment, prior GI/pancreatic surgery or disease, recent major weight loss, smokers, or those on interfering medications—are unlikely to match the study population and may not gain direct benefit.
Why it matters
Potential benefit: If successful, the findings could reveal hormone interactions that inform new strategies to reduce appetite and guide obesity treatments.
How similar studies have performed: Amylin (pramlintide) has been shown in prior studies to reduce food intake, but combining amylin with pancreatic polypeptide in humans is relatively novel and not well studied.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Hellerup, Capital Region
- Center for Clinical Metabolic Research, Gentofte Hospital — Hellerup, Capital Region, Denmark (RECRUITING)
Study contacts
- Study coordinator: Andreas H Lange
- Email: andreas.holst.lange@rehionh.dk
- Phone: +4553807019
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Obesity & Overweight, Amylin, Pramlintide, Food Intake