HungerPhase 4NCT03854708
Effect of Pancreatic Polypeptide on Gastric Motor Function and Food Intake in Humans
A Phase 4 study testing 3 pmol/kg*min pancreatic polypeptide and 10 pmol/kg*min pancreatic polypeptide in people with Hunger, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Hunger
- What is being tested?
- 3 pmol/kg*min pancreatic polypeptide and 10 pmol/kg*min pancreatic polypeptide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 1 siteBelgium
- Study dates
- 31 Aug 2010to 8 Mar 2011
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Show all 12Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Pancreatic Polypeptide on Intragastric Pressure and Satiety During Nutrient Drink Infusion
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.
Read the 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
- Being tested
- 3 pmol/kg*min pancreatic polypeptide, 10 pmol/kg*min pancreatic polypeptide, Placebo
- Keywords
- gastric accommodation, gastric emptying, hunger, satiety, nutrient tolerance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3 pmol/kg*min pancreatic polypeptideDrug
Also called 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.
10 pmol/kg*min pancreatic polypeptideDrug
Also called 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.
PlaceboDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 3 pmol/kg*min pancreatic polypeptide | Experimental | 3 pmol/kg*min of pancreatic polypeptide was intravenously infused. Receives: Drug: 3 pmol/kg*min pancreatic polypeptide |
| 10 pmol/kg*min pancreatic polypeptide | Experimental | 10 pmol/kg*min of pancreatic polypeptide was intravenously infused. Receives: Drug: 10 pmol/kg*min pancreatic polypeptide |
| Placebo | Placebo comparator | 0.9 % saline solution was intravenously infused. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The effect of different doses of pancreatic polypeptide infusion on the gastric accommodation (intragastric pressure drop) after nutrient drink infusion.
Intragastric pressure measurements were assessed using a 36-channel high-resolution solid-state manometry probe. After nutrient drink infusion, the intragastric pressure drops to a minimum value (Nadir), which is a measurement for gastric accommodation, and the pressure restores after. The time point of reaching the Nadir is different between subjects, but pressure is measured until 2 hours after nutrient drink to assess the drop.
Measured: 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 (3)
The effect of different doses of pancreatic polypeptide infusion on nutrient tolerance.
Liquid nutrient drink was infused at a constant speed of 60 ml/min. At 1-min intervals subjects were asked to score their satiation using a graphic rating scale that combines verbal descriptors on a scale graded from 0 to 5 (0 is threshold, 5 is maximal satiation. Infusion stopped when the subject reached maximal satiation. The time of infusion is a measurement of their nutrient tolerance.
Measured: Infusion of the liquid meal ends after 20 minutes or earlier if max satiation is reached by the subjects.
The effect of different doses of pancreatic polypeptide infusion on gastric emptying rate.
Gastric emptying rate after placebo and PP 10 pmol/kg*min administration was quantified using the breath test. 13C-labeled sodium octanoate were added to the ND (200 mg/L) and emptying of the stomach was assessed by analysis of the exhaled 13CO2.
Measured: Breath samples were collected in exetainers, twice before and every 15 min after the meal until 6 hours thereafter.
The effect of different doses of pancreatic polypeptide infusion on satiety and return of hunger.
The subjects rate their feeling of satiety (in fasted state)/satiation (in fed state) and hunger using a 100 mm line ranging from 0 to 100, as a response on the questions: 'How hungry do you feel? ' and 'How satisfied do you feel?'. 0 means 'not at all', and 100 means 'extremely much'.
These feelings cannot be considered to have a better or worse outcome. One expect to have higher hunger and lower satiety scores in fasted state and lower hunger and higher satiation scores in the fed state.
Measured: Satiety and hunger were scored twice before and every 15 min after the meal until 6 hours thereafter.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2019
- Study start31 Aug 2010
- Primary completion8 Mar 2011
- Study completion8 Mar 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HungerStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jan Tack, Principal investigator, UZ Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03854708
- Sponsor's protocol ID
- PP and gastric motility
- Status last verified
- Jan 2019
- First submitted
- 1 Feb 2019
- Last updated
- 26 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 34435472
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Pancreatic Polypeptide on Intragastric Pressure and Satiety During Nutrient Drink Infusion
- ClinicalTrials.gov ID
- NCT03854708
- Acronym / sponsor ID
- PP and gastric motility
- Conditions
- Hunger
- Keywords
- gastric accommodation, gastric emptying, hunger, satiety, nutrient tolerance
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- 31 Aug 2010 (actual)
- Primary completion
- 8 Mar 2011 (actual)
- Study completion
- 8 Mar 2011 (actual)
- First posted
- 26 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 3 pmol/kg*min pancreatic polypeptide | Experimental | Drug: 3 pmol/kg*min pancreatic polypeptide3 pmol/kg*min of pancreatic polypeptide was intravenously infused. |
| 10 pmol/kg*min pancreatic polypeptide | Experimental | Drug: 10 pmol/kg*min pancreatic polypeptide10 pmol/kg*min of pancreatic polypeptide was intravenously infused. |
| Placebo | Placebo comparator | Drug: Placebo0.9 % saline solution was intravenously infused. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 3 pmol/kg*min pancreatic polypeptideAlso: 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. | Drug | 3 pmol/kg*min pancreatic polypeptide |
| 10 pmol/kg*min pancreatic polypeptideAlso: 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. | Drug | 10 pmol/kg*min pancreatic polypeptide |
| PlaceboPlacebo (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. | Drug | Placebo |
Primary outcome
The effect of different doses of pancreatic polypeptide infusion on the gastric accommodation (intragastric pressure drop) after nutrient drink infusion.
Time frame: Until 2 hours after the start of the liquid meal. Liquid meal started 30 minutes after pancreatic peptide dose or placebo iv infusion.
Intragastric pressure measurements were assessed using a 36-channel high-resolution solid-state manometry probe. After nutrient drink infusion, the intragastric pressure drops to a minimum value (Nadir), which is a measurement for gastric accommodation, and the pressure restores after. The time point of reaching the Nadir is different between subjects, but pressure is measured until 2 hours after nutrient drink to assess the drop.
3 secondary outcomes
The effect of different doses of pancreatic polypeptide infusion on nutrient tolerance.
Time frame: Infusion of the liquid meal ends after 20 minutes or earlier if max satiation is reached by the subjects.
The effect of different doses of pancreatic polypeptide infusion on gastric emptying rate.
Time frame: Breath samples were collected in exetainers, twice before and every 15 min after the meal until 6 hours thereafter.
The effect of different doses of pancreatic polypeptide infusion on satiety and return of hunger.
Time frame: Satiety and hunger were scored twice before and every 15 min after the meal until 6 hours thereafter.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2019.
- Derived from this study: PubMed 34435472Verbeure 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jan Tack principal investigator
UZ Leuven
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing 3 pmol/kg*min pancreatic polypeptide and 10 pmol/kg*min pancreatic polypeptide in people with Hunger, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The effect of different doses of pancreatic polypeptide infusion on the gastric accommodation (intragastric pressure drop) after nutrient drink infusion. (time frame: Until 2 hours after the start of the liquid meal. Liquid meal started 30 minutes after pancreatic peptide dose or placebo iv infusion.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03854708, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Feb 2019.