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

University Hospital, Gentofte, Copenhagen18 enrolled

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

DOUBLE

Enrollment

Conditions

Obesity & Overweight

Interventions

Eligibility

Sex: MALEMin age: 18 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Food intake

Difference in food intake during an ad libitum meal. Food intake is examined as kalories (kcal) of food eaten during the ad libitum meal.

Time frame: 300 to 330 minutes

Secondary Outcomes

Composite appetite score

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

Time frame: -30 min to 330

Sensations of hunger, satiety, fullness, prospective food intake, nausea, thirst, comfort

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.

Time frame: -30 to 330 minutes