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CompletedNCT03854708

Effect of Pancreatic Polypeptide on Gastric Motor Function and Food Intake in Humans

Effect of Pancreatic Polypeptide on Intragastric Pressure and Satiety During Nutrient Drink Infusion

Status
Completed
Phase
Phase 4
Study type
Interventional
Enrollment
12 (actual)
Sponsor
Universitaire Ziekenhuizen KU Leuven · Academic / Other
Sex
All
Age
18 Years – 65 Years
Healthy volunteers
Accepted

Summary

The investigators want to observe whether different doses of pancreatic polypeptide infusions influence gastric accommodation (measured as intragastric pressure changes during a liquid meal infusion), gastric emptying and food intake.

Detailed description

As pancreatic polypeptide (PP) influences food behavior in humans, our research group suggests a role via the the gastric accommodation or gastric emptying. Twelve healthy volunteers participated in this single blind, placebo-controlled, crossover trial. An infusion catheter and a manometry probe were positioned in the stomach. After a 15 min stabilization period, saline (placebo), PP 3 pmol/kg\*min or PP 10 pmol/kg\*min were intravenously infused. Thirty min after the condition, an intragastric nutrient drink (ND) infusion (60 ml/min) started until the volunteer felt maximal satiated. GE was evaluated using the 13C breath test during the 6 hours following the ND infusion. Satiation and hunger were scored on a visual analog scale every 5 minutes.

Conditions

Interventions

TypeNameDescription
DRUG3 pmol/kg*min pancreatic polypeptidePP 3 pmol/kg\*min was intravenously infused 30 minutes before the meal until the end of the meal. For this purpose, a cannula was inserted into the subjects' forearm vein. Human PP (CS Bio, Menlo Park, USA) was dissolved in a 0.9 % saline solution containing 5 % albumin to reduce absorption of PP to the syringe and tubing.
DRUG10 pmol/kg*min pancreatic polypeptidePP 10 pmol/kg\*min was intravenously infused 30 minutes before the meal until the end of the meal. For this purpose, a cannula was inserted into the subjects' forearm vein. Human PP (CS Bio, Menlo Park, USA) was dissolved in a 0.9 % saline solution containing 5 % albumin to reduce absorption of PP to the syringe and tubing.
DRUGPlaceboPlacebo (saline solution) was intravenously infused 30 minutes before the meal until the end of the meal. For this purpose, a cannula was inserted into the subjects' forearm vein. The placebo consists of a 0.9 % saline solution containing 5 % albumin.

Timeline

Start date
2010-08-31
Primary completion
2011-03-08
Completion
2011-03-08
First posted
2019-02-26
Last updated
2019-02-26

Locations

1 site across 1 country: Belgium

Source: ClinicalTrials.gov record NCT03854708. Inclusion in this directory is not an endorsement.