Trials / Completed
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
| Type | Name | Description |
|---|---|---|
| DRUG | 3 pmol/kg*min pancreatic polypeptide | PP 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. |
| DRUG | 10 pmol/kg*min pancreatic polypeptide | PP 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. |
| DRUG | Placebo | Placebo (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.