Obesity & Overweight
Conditions
Keywords
Amylin, Pramlintide, Food Intake
Brief summary
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
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
This a one of the pancreatic hormones investigated in this study.
This the placebo
Sponsors
University Hospital, Gentofte, Copenhagen
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
MALE
Age
18 Years to 65 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Food intake | 300 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Composite appetite score | -30 min to 330 | 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 |
| Sensations of hunger, satiety, fullness, prospective food intake, nausea, thirst, comfort | -30 to 330 minutes | 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. |
Countries
Denmark
Contacts
CONTACTAndreas H Lange
Outcome results
None listed