Clinical trial

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

Recruiting now · Not applicable · 1 countries · Registry ID NCT07506369

Recruiting nowNot applicableInterventional

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to 65 Years

SexMale

Healthy volunteersAccepted

ConditionObesity & Overweight

Full registry 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

Treatments and study arms

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

Pancreatic Polypeptide (PP)

Drug

This a one of the pancreatic hormones investigated in this study.

Placebo (NaCl 0.9 % solution)

Drug

This the placebo

Primary outcomes

Food intake300 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.

Study locations

1 locations were listed when this page was built. The first 40 are shown.

Center for Clinical Metabolic Research, Gentofte Hospital🇩🇰 Hellerup, Capital Region, Denmark

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Andreas H LangeContact

Email · Call +4553807019