Status:
COMPLETED
Effect of Pancreatic Polypeptide on Gastric Motor Function and Food Intake in Humans
Lead Sponsor:
Universitaire Ziekenhuizen KU Leuven
Conditions:
Hunger
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
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),...
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 t...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 31 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 8 2011
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT03854708
Start Date
August 31 2010
End Date
March 8 2011
Last Update
February 26 2019
Active Locations (1)
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1
Jan Tack
Leuven, Belgium, 3000