Vagotomy, TruncalNCT01176760
Intact Vagal Innervation for and Glucagon-like Peptide-1 (GLP-1) Effects
A study testing Dipeptidyl peptidase 4 (DPP 4) inhibitor and oral glucose 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 glucose and Glucagon-like peptide-1 (GLP-1) in respect to insulin secretion. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Vagotomy, Truncal
- What is being tested?
- Dipeptidyl peptidase 4 (DPP 4) inhibitor and oral glucose
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteDenmark
- Study dates
- Aug 2009to 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 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- normal fasting plasma glucose
- normal hemoglobin
- informed consent
Who cannot join
- type 1 diabetes mellitus or type 2 diabetes mellitus
- body mass index > 30
- inflammatory bowel disease
- intestinal surgery
- serum creatinine > 250 µM and/or albuminuria
- ALAT > 2 x normal value
- Severe cardiac insufficiency
- in 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, Gentofte Hospital
Hellerup, Copenhagen, 2900
About this study
Official title: The Significances of Intact Vagal Innervation for the Glucose and GLP1 Induced Insulin Secretion
The aim of this study is to investigate the role of transmission via the vagal nerve for the effect of glucose and Glucagon-like peptide-1 (GLP-1) in respect to insulin secretion.
The hypothesis is that a great deal of the effects of GLP-1 is mediated via the nervous system and for this reason the investigators will research 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 glucose and GLP-1 on the insulin secretion
- Conditions
- Vagotomy, Truncal
- Being tested
- Dipeptidyl peptidase 4 (DPP 4) inhibitor, oral glucose
- Keywords
- vagotomy, vagus, GLP-1, Insulin secretion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dipeptidyl peptidase 4 (DPP 4) inhibitorDrug
Also called Galvus
One tablet (50 mg)of DPP4 inhibitor is to be taken 12 and 1 hours before start of the oral glucose tolerance test (50 g glucose and 1.5 g paracetamol dissolved in 300 ml water)on day 3
oral glucoseOther
Also called panodil
50 g glucose dissolved in 300 ml water with 1,5 g paracetamol is to be ingested orally within the first 15 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Vago | Experimental | Truncally vagotomized subjects (due to duodenal ulcer operation) Receives: Drug: Dipeptidyl peptidase 4 (DPP 4) inhibitor; Other: oral glucose |
| Cardia | Experimental | Truncally vagotomized subjects (due to cardia resection) Receives: Drug: Dipeptidyl peptidase 4 (DPP 4) inhibitor; Other: oral glucose |
| Ctrl | Experimental | Healthy matched control subjects Receives: Drug: Dipeptidyl peptidase 4 (DPP 4) inhibitor; Other: oral glucose |
What is being measured
The primary outcome is the main question the study is designed to answer.
insulin secretion
The insulin secretion during a four-hour oral glucose tolerance test (OGTT) and an intravenous isoglycaemic clamp is evaluated
Measured: four hours
Secondary outcomes (5)
plasma GLP-1
12 blood samples will be drawn during the four hours OGTT and intravenous isoglycaemic clamp, most frequently during the first hour
Measured: 12 time points within four hours
plasma GIP
12 blood samples will be drawn during the four hours OGTT and intravenous isoglycaemic clamp, most frequently during the first hour
Measured: 12 time points within four hours
plasma glucagon
12 blood samples will be drawn during the four hours OGTT and intravenous isoglycaemic clamp, most frequently during the first hour
Measured: 12 time points within four hours
plasma GLP-2
12 blood samples will be drawn during the four hours OGTT and intravenous isoglycaemic clamp, most frequently during the first hour
Measured: 12 time points within four hours
plasma PYY
12 blood samples will be drawn during the four hours OGTT and intravenous isoglycaemic clamp, most frequently during the first hour
Measured: 12 time points within 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 startAug 2009
- Primary completionOct 2011
- Study completionDec 2012 (estimated)
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 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, MD, Principal investigator, University Hospital, Gentofte, CopenhagenTina Vilsbøll, MD, dr.med, Study director, University Hospital, Gentofte, Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01176760
- Sponsor's protocol ID
- Truncated isoglycemia
- Status last verified
- Dec 2012
- First submitted
- 5 Aug 2010
- Last updated
- 7 Dec 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Plamboeck A, Veedfald S, Deacon CF, Hartmann B, Wettergren A, Svendsen LB, Meisner S, Hovendal C, Knop FK, Vilsboll T, Holst JJ. Characterisation of oral and i.v. glucose handling in truncally vagotomised subjects with pyloroplasty. Eur J Endocrinol. 2013 Jul 6;169(2):187-201. doi: 10.1530/EJE-13-0264. Print 2013 Aug.
PubMed 23704713
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 Significances of Intact Vagal Innervation for the Glucose and GLP1 Induced Insulin Secretion
- ClinicalTrials.gov ID
- NCT01176760
- Acronym / sponsor ID
- Truncated isoglycemia
- Conditions
- Vagotomy, Truncal
- Keywords
- vagotomy, vagus, GLP-1, Insulin secretion
- 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
- Aug 2009
- Primary completion
- Oct 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 glucose and Glucagon-like peptide-1 (GLP-1) in respect to insulin secretion.
The hypothesis is that a great deal of the effects of GLP-1 is mediated via the nervous system and for this reason the investigators will research 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 glucose and GLP-1 on the insulin secretion
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: Dipeptidyl peptidase 4 (DPP 4) inhibitor, Other: oral glucoseTruncally vagotomized subjects (due to duodenal ulcer operation) |
| Cardia | Experimental | Drug: Dipeptidyl peptidase 4 (DPP 4) inhibitor, Other: oral glucoseTruncally vagotomized subjects (due to cardia resection) |
| Ctrl | Experimental | Drug: Dipeptidyl peptidase 4 (DPP 4) inhibitor, Other: oral glucoseHealthy matched control subjects |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- normal fasting plasma glucose
- normal hemoglobin
- informed consent
Key exclusion criteria (8 listed)
- type 1 diabetes mellitus or type 2 diabetes mellitus
- body mass index > 30
- inflammatory bowel disease
- intestinal surgery
- serum creatinine > 250 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 |
|---|---|---|
| Dipeptidyl peptidase 4 (DPP 4) inhibitorAlso: GalvusOne tablet (50 mg)of DPP4 inhibitor is to be taken 12 and 1 hours before start of the oral glucose tolerance test (50 g glucose and 1.5 g paracetamol dissolved in 300 ml water)on day 3 | Drug | Cardia, Ctrl, Vago |
| oral glucoseAlso: panodil50 g glucose dissolved in 300 ml water with 1,5 g paracetamol is to be ingested orally within the first 15 minutes. | Other | Cardia, Ctrl, Vago |
Primary outcome
insulin secretion
Time frame: four hours
The insulin secretion during a four-hour oral glucose tolerance test (OGTT) and an intravenous isoglycaemic clamp is evaluated
5 secondary outcomes
plasma GLP-1
Time frame: 12 time points within four hours
plasma GIP
Time frame: 12 time points within four hours
plasma glucagon
Time frame: 12 time points within four hours
plasma GLP-2
Time frame: 12 time points within four hours
plasma PYY
Time frame: 12 time points within 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 23704713Plamboeck A, Veedfald S, Deacon CF, Hartmann B, Wettergren A, Svendsen LB, Meisner S, Hovendal C, Knop FK, Vilsboll T, Holst JJ. Characterisation of oral and i.v. glucose handling in truncally vagotomised subjects with pyloroplasty. Eur J Endocrinol. 2013 Jul 6;169(2):187-201. doi: 10.1530/EJE-13-0264. Print 2013 Aug.
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, MD principal investigator
University Hospital, Gentofte, Copenhagen
Tina Vilsbøll, MD, dr.med 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 Dipeptidyl peptidase 4 (DPP 4) inhibitor and oral glucose 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 3 inclusion and 8 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?
insulin secretion (time frame: four hours). 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 NCT01176760, 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 7 Dec 2012.