Vagotomy, TruncalNCT01176890
Intact Vagal Innervation and Glucagon-like Peptide-1 (GLP-1) Effects
A study testing GLP-1 and Saline in people with Vagotomy, Truncal, run by University Hospital, Gentofte, Copenhagen at 1 site in Denmark.
Trial summary
The aim of this study is to investigate the role of transmission via the vagal nerve for the effect of Glucagon-like peptide-1 (GLP-1) in respect to gastric emptying, appetite and food intake. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Vagotomy, Truncal
- What is being tested?
- GLP-1 and Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteDenmark
- Study dates
- Jul 2008to Dec 2012
- Phase
- Interventional
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- truncal vagotomy
- normal hemoglobin
- informed consent
- Age, gender and weight matched controls
- normal hemoglobin
- informed consent
Who cannot join
- type 1 diabetes mellitus or type 2 diabetes mellitus
- body mass index > 30 kg/m2
- inflammatory bowel disease
- intestinal resection
- nephropathy (serum creatinine > 150 µM and/or albuminuria)
- liver disease (ALAT and/or ASAT > 2 x normal value)
- treatment with medicine which cannot be paused for 12 hours
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of Internal Medicine F' laboratory
Hellerup, Copenhagen, 2900
About this study
Official title: The Significance of Intact Vagal Innervation for the GLP-1 Induced Inhibition of Gastric Emptying, Appetite and Food Intake
The aim of this study is to investigate the role of transmission via the vagal nerve for the effect of Glucagon-like peptide-1 (GLP-1) in respect to gastric emptying, appetite and food intake.
The hypothesis is that a great deal of the effects of GLP-1 is mediated via the nervous system and for this reason the researchers will investigate individuals with and without intact nervous supply.
Read the detailed description
GLP-1 is a potent enterogastron and incretin hormone. It is rapidly inactivated by dipeptidyl peptidase IV so only 10-15% enters the systemic circulation. This has led to the hypothesis that GLP-1 interact locally with afferent sensory nerve fibers. We investigated the role of intact vagal innervations on the effect of GLP-1 on the food intake, gastric emptying (GE) and appetite.
- Conditions
- Vagotomy, Truncal
- Being tested
- GLP-1, Saline
- Keywords
- truncal vagotomy, GLP-1, gastric emptying, appetite, food intake
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GLP-1Drug
Also called Panodil
1.2 pmol/kg/min GLP-1 will be infused intravenously during the four hour meal test (100 g Ny NAN1 and 1.5 g paracetamol dissolved in 300 ml water) ingested over 10 minutes.
After four hours an ad libitum meal will be supplied
SalineOther
Also called Panodil
Saline (isotonic NaCl) will be infused intravenously during the four hour meal test (100 g Ny NAN1 and 1.5 g paracetamol dissolved in 300 ml water) ingested over 10 minutes.
After four hours an ad libitum meal will be supplied
| Study group | Role | What they receive |
|---|---|---|
| Vago | Experimental | Truncally vagotomized subjects (due to duodenal ulcer operation) Receives: Drug: GLP-1; Other: Saline |
| Cardia | Experimental | truncally vagotomized subjects (due to esophagus resection) Receives: Drug: GLP-1; Other: Saline |
| Healthy controls | Experimental | Healthy control subjects Receives: Drug: GLP-1; Other: Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gastric emptying
Gastric emptying will be assessed using a liquid meal with 1.5 g paracetamol added and continuous blood sampling for measuring paracetamol concentration during four hours
Measured: four hours
Appetite
Hunger, satiation, and fullness will be assessed before, during and after a liquid meal with 1.5 g paracetamol added using a visual analog scale (VAS)
Measured: four hours
Food intake
After the liquid meal test, the volunteers will be offered a meal to assessed their ad libitum food intake
Measured: five hours
Secondary outcomes (7)
plasma glucose
Measured: four hours
serum insulin and c-peptide
Measured: four hours
plasma glucagon
Measured: four hours
plasma GLP-1
Measured: four hours
endogenous GLP-1
endogenous GLP-1 will be assessed as plasma GLP-2 concentration
Measured: four hours
plasma GIP
Measured: four hours
serum paracetamol
Measured: four hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2010 (estimated)
- Study startJul 2008
- Primary completionAug 2011
- Study completionDec 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Vagotomy, TruncalStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Gentofte, Copenhagen
- Sponsor type
- University, hospital or other
- Collaborators
- University of Copenhagen
- Responsible party
- Principal investigator, Jonatan I Bagger, University Hospital, Gentofte, Copenhagen
- Investigators
- Astrid Plamboeck, M.D., Principal investigator, University Hospital, Gentofte, CopenhagenTina Vilsbøll, M.D., Study director, University Hospital, Gentofte, Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01176890
- Sponsor's protocol ID
- Truncated mealtest (AP)
- Status last verified
- Dec 2012
- First submitted
- 5 Aug 2010
- Last updated
- 7 Dec 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Wewer Albrechtsen NJ, Hartmann B, Veedfald S, Windelov JA, Plamboeck A, Bojsen-Moller KN, Idorn T, Feldt-Rasmussen B, Knop FK, Vilsboll T, Madsbad S, Deacon CF, Holst JJ. Hyperglucagonaemia analysed by glucagon sandwich ELISA: nonspecific interference or truly elevated levels? Diabetologia. 2014 Sep;57(9):1919-26. doi: 10.1007/s00125-014-3283-z. Epub 2014 Jun 3.
PubMed 24891019Plamboeck A, Veedfald S, Deacon CF, Hartmann B, Wettergren A, Svendsen LB, Meisner S, Hovendal C, Vilsboll T, Knop FK, Holst JJ. The effect of exogenous GLP-1 on food intake is lost in male truncally vagotomized subjects with pyloroplasty. Am J Physiol Gastrointest Liver Physiol. 2013 Jun 15;304(12):G1117-27. doi: 10.1152/ajpgi.00035.2013. Epub 2013 Apr 18.
PubMed 23599045
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Significance of Intact Vagal Innervation for the GLP-1 Induced Inhibition of Gastric Emptying, Appetite and Food Intake
- ClinicalTrials.gov ID
- NCT01176890
- Acronym / sponsor ID
- Truncated mealtest (AP)
- Conditions
- Vagotomy, Truncal
- Keywords
- truncal vagotomy, GLP-1, gastric emptying, appetite, food intake
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University Hospital, Gentofte, CopenhagenUniversity, hospital or other
- Collaborators
- University of Copenhagen
- Study start
- Jul 2008
- Primary completion
- Aug 2011 (actual)
- Study completion
- Dec 2012 (estimated)
- First posted
- 6 Aug 2010 (estimated)
- 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 aim of this study is to investigate the role of transmission via the vagal nerve for the effect of Glucagon-like peptide-1 (GLP-1) in respect to gastric emptying, appetite and food intake.
The hypothesis is that a great deal of the effects of GLP-1 is mediated via the nervous system and for this reason the researchers will investigate individuals with and without intact nervous supply.
Detailed description
GLP-1 is a potent enterogastron and incretin hormone. It is rapidly inactivated by dipeptidyl peptidase IV so only 10-15% enters the systemic circulation. This has led to the hypothesis that GLP-1 interact locally with afferent sensory nerve fibers. We investigated the role of intact vagal innervations on the effect of GLP-1 on the food intake, gastric emptying (GE) and appetite.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Vago | Experimental | Drug: GLP-1, Other: SalineTruncally vagotomized subjects (due to duodenal ulcer operation) |
| Cardia | Experimental | Drug: GLP-1, Other: Salinetruncally vagotomized subjects (due to esophagus resection) |
| Healthy controls | Experimental | Drug: GLP-1, Other: SalineHealthy control subjects |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- truncal vagotomy
- normal hemoglobin
- informed consent
- Age, gender and weight matched controls
- normal hemoglobin
Key exclusion criteria (7 listed)
- type 1 diabetes mellitus or type 2 diabetes mellitus
- body mass index > 30 kg/m2
- inflammatory bowel disease
- intestinal resection
- nephropathy (serum creatinine > 150 µM and/or albuminuria)
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 |
|---|---|---|
| GLP-1Also: Panodil1.2 pmol/kg/min GLP-1 will be infused intravenously during the four hour meal test (100 g Ny NAN1 and 1.5 g paracetamol dissolved in 300 ml water) ingested over 10 minutes. After four hours an ad libitum meal will be supplied | Drug | Cardia, Healthy controls, Vago |
| SalineAlso: PanodilSaline (isotonic NaCl) will be infused intravenously during the four hour meal test (100 g Ny NAN1 and 1.5 g paracetamol dissolved in 300 ml water) ingested over 10 minutes. After four hours an ad libitum meal will be supplied | Other | Cardia, Healthy controls, Vago |
Primary outcome
Gastric emptying
Time frame: four hours
Gastric emptying will be assessed using a liquid meal with 1.5 g paracetamol added and continuous blood sampling for measuring paracetamol concentration during four hours
Appetite
Time frame: four hours
Hunger, satiation, and fullness will be assessed before, during and after a liquid meal with 1.5 g paracetamol added using a visual analog scale (VAS)
Food intake
Time frame: five hours
After the liquid meal test, the volunteers will be offered a meal to assessed their ad libitum food intake
7 secondary outcomes
plasma glucose
Time frame: four hours
serum insulin and c-peptide
Time frame: four hours
plasma glucagon
Time frame: four hours
plasma GLP-1
Time frame: four hours
endogenous GLP-1
Time frame: four hours
plasma GIP
Time frame: four hours
serum paracetamol
Time frame: four hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2012.
- Derived from this study: PubMed 24891019Wewer Albrechtsen NJ, Hartmann B, Veedfald S, Windelov JA, Plamboeck A, Bojsen-Moller KN, Idorn T, Feldt-Rasmussen B, Knop FK, Vilsboll T, Madsbad S, Deacon CF, Holst JJ. Hyperglucagonaemia analysed by glucagon sandwich ELISA: nonspecific interference or truly elevated levels? Diabetologia. 2014 Sep;57(9):1919-26. doi: 10.1007/s00125-014-3283-z. Epub 2014 Jun 3.
- Derived from this study: PubMed 23599045Plamboeck A, Veedfald S, Deacon CF, Hartmann B, Wettergren A, Svendsen LB, Meisner S, Hovendal C, Vilsboll T, Knop FK, Holst JJ. The effect of exogenous GLP-1 on food intake is lost in male truncally vagotomized subjects with pyloroplasty. Am J Physiol Gastrointest Liver Physiol. 2013 Jun 15;304(12):G1117-27. doi: 10.1152/ajpgi.00035.2013. Epub 2013 Apr 18.
Related trials for Vagotomy, Truncal
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.
Astrid Plamboeck, M.D. principal investigator
University Hospital, Gentofte, Copenhagen
Tina Vilsbøll, M.D. study director
University Hospital, Gentofte, Copenhagen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing GLP-1 and Saline in people with Vagotomy, Truncal, run by University Hospital, Gentofte, Copenhagen at 1 site in Denmark.
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 6 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 7 Dec 2012. 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 Denmark. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
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?
Gastric emptying (time frame: four hours). The study lists 3 primary outcomes in all. 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 NCT01176890, which also lists 2 linked publications.
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 7 Dec 2012.