Clinical trial NCT03854708: Effect of Pancreatic Polypeptide on Gastric Motor Function and Food Intake in Humans
Official title: Effect of Pancreatic Polypeptide on Intragastric Pressure and Satiety During Nutrient Drink Infusion
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hunger
Keywords: gastric accommodation
gastric emptying
hunger
satiety
nutrient tolerance
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
First posted: 2019-02-26
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief 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.

Eligibility criteria: Inclusion Criteria:

* Subject is between 18 and 65 years of age.
* Women of child-bearing potential agree to apply during the entire duration of the trial a highly effective method of birth control, which is defined as those which result in a low failure rate (i.e., less than 1% per year) when used constantly and correctly such as implants, injectables, combined oral contraceptive method, or some intrauterine devices (IUDs), sexual abstinence, or vasectomized partner. Women of non-childbearing potential may be included if surgically sterile (tubal ligation or hysterectomy) or postmenopausal with at least 2 year without spontaneous menses.
* Subject understands the study procedures and agrees to participate in the study by giving written informed consent.

Exclusion Criteria:

* Subject is under age of legal consent, pregnant or breastfeeding.
* Subject has current symptoms or a history of gastrointestinal or other significant somatic or psychiatric diseases or drug allergies.
* Subject has a significant heart, lung, liver or kidney disease.
* Subject has any history of a neurological disorder. Subject has a history of abdominal surgery. Those having undergone a simple appendectomy more than 1 year prior to the screening visit may participate.
* History or current use of drugs that can affect glycaemia, gastrointestinal function, motility or sensitivity or gastric acidity.
* History or current use of centrally acting medication, including antidepressants, antipsychotics and/or benzodiazepines (in the last year before screening visit).
* Subject consumes excessive amounts of alcohol, defined as \>14 units per week for females and \> 21 units per week for males.
* Subject is currently (defined as within approximately 1 year of the screening visit) a regular or irregular user (including "recreational use") of any illicit drugs (including marijuana) or has a history of drug (including alcohol) abuse. Further, patient is unwilling to refrain from the use of drugs during this study.
* High caffeine intake (\> 500 ml coffee daily or equivalent).
* Inability or unwillingness to perform all of the study procedures, or the subject is considered unsuitable in any way by the principal investigator.
* Recent participation (\<30 days) or simultaneous participation in another clinical study.
* Subjects with lactose intolerance.

Primary outcomes:
measure: The effect of different doses of pancreatic polypeptide infusion on the gastric accommodation (intragastric pressure drop) after nutrient drink infusion.
timeFrame: Until 2 hours after the start of the liquid meal. Liquid meal started 30 minutes after pancreatic peptide dose or placebo iv infusion.
Secondary outcomes:
measure: The effect of different doses of pancreatic polypeptide infusion on nutrient tolerance.
timeFrame: Infusion of the liquid meal ends after 20 minutes or earlier if max satiation is reached by the subjects.
measure: The effect of different doses of pancreatic polypeptide infusion on gastric emptying rate.
timeFrame: Breath samples were collected in exetainers, twice before and every 15 min after the meal until 6 hours thereafter.
measure: The effect of different doses of pancreatic polypeptide infusion on satiety and return of hunger.
timeFrame: Satiety and hunger were scored twice before and every 15 min after the meal until 6 hours thereafter.
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: Jan Tack
Study officials:
affiliation: UZ Leuven
name: Jan Tack
role: PRINCIPAL_INVESTIGATOR
References:
citation: Verbeure W, Rotondo A, Janssen P, Carbone F, Tack J. Supraphysiological effects of pancreatic polypeptide on gastric motor function and nutrient tolerance in humans. Physiol Rep. 2021 Sep;9(17):e15002. doi: 10.14814/phy2.15002.