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

NCT ID: NCT03854708

Last Updated: 2019-02-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-08-31
• Study Completion Date: 2011-03-08

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.

Conditions

Hunger

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

3 pmol/kg*min pancreatic polypeptide

3 pmol/kg\*min of pancreatic polypeptide was intravenously infused.

Group Type: EXPERIMENTAL

3 pmol/kg*min pancreatic polypeptide

Intervention Type: DRUG

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.

10 pmol/kg*min pancreatic polypeptide

10 pmol/kg\*min of pancreatic polypeptide was intravenously infused.

Group Type: EXPERIMENTAL

10 pmol/kg*min pancreatic polypeptide

Intervention Type: DRUG

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.

Placebo

0.9 % saline solution was intravenously infused.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: DRUG

Other Intervention Names

Pancreatic polypeptide; Pancreatic polypeptide

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Universitaire Ziekenhuizen KU Leuven

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jan Tack

Role: PRINCIPAL_INVESTIGATOR

UZ Leuven

Locations

Jan Tack

Leuven, , Belgium

Countries

Belgium

References

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.

Reference Type: DERIVED

PMID: 34435472 (View on PubMed)

Other Identifiers

PP and gastric motility

Identifier Type: -

Identifier Source: org_study_id