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

ConditionObesity & Overweight
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age18-65
SponsorUniversity Hospital, Gentofte, Copenhagen

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Male

Age between 18 and 65 years at the time of inclusion

Body mass index 18-27 kg/m2

Fat percentage < 20%

Disqualifiers

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)

Trial design

Design model

Crossover

Treatments tested in this trial

  • 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

Treatment groups

18 Participants
are divided into 4 treatment groups
Group A: Amylin (Pramlintide) + PlaceboActive comparator 2 interventions
Group B: PP + PlaceboActive comparator 2 interventions
Group C: Amylin (Pramlintide) + PPActive comparator 2 interventions
Group D: Placebo + PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

1

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
2

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University Hospital, Gentofte, Copenhagen

Lead sponsor

Source ClinicalTrials.gov
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