Liver TransplantationNCT01176708
Intact Liver Innervation and Glucose and Glucagon-like Peptide-1 (GLP-1) Induced Insulin Secretion
A study testing dipeptidyl peptidase 4 (DPP4) inhibitor, oral glucose and intravenous glucose in people with Liver Transplantation, run by University Hospital, Gentofte, Copenhagen at 1 site in Denmark.
Trial summary
The aim of the study is to investigate the significance of intact nerve supply to the liver for the glucagon-like peptide-1 (GLP-1) induced insulin secretion. The hypothesis is that the effects of GLP-1 is transmitted through the GLP-1 receptor and that these effects involve sensory afferent neurons, probably… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Liver Transplantation
- What is being tested?
- dipeptidyl peptidase 4 (DPP4) inhibitor, oral glucose and intravenous glucose
- Type of treatment
- Pill or oral medicine, 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 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 years and older
- 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, 1 recruiting
- Recruiting
Department of Internal Medicine F' laboratory
Hellerup, Copenhagen, 2900
Astrid Plamboeck, M.D., +45 26208174, astridp@sund.ku.dk
Tina Vilsbøll, M.D., +45 39772461, tivi@geh.regionh.dk
About this study
Official title: The Significance of Intact Liver Innervation for the Glucose and GLP-1 Induced Insulin Secretion
The aim of the study is to investigate the significance of intact nerve supply to the liver for the glucagon-like peptide-1 (GLP-1) induced insulin secretion.
The hypothesis is that the effects of GLP-1 is transmitted through the GLP-1 receptor and that these effects involve sensory afferent neurons, probably primarily parasympathetic.
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.
The aim of this study is to investigate the significance of intact liver innervation for the GLP-1 induced insulin secretion in liver transplanted patients; kidney transplanted control patients matched for immunosuppressive treatment, age, gender and body weight; and ten control persons matched for age, gender and body weight.
The insulin secretion will be evaluated from blood samples that will be analyzed for insulin and c-peptide.
- Conditions
- Liver Transplantation
- Being tested
- dipeptidyl peptidase 4 (DPP4) inhibitor, oral glucose, intravenous glucose
- Keywords
- liver transplantation, kidney transplanted, glucagon-like peptide-1, insulin secretion, vagotomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dipeptidyl peptidase 4 (DPP4) 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 grams glucose dissolved in 300 ml water with 1.5 grams paracetamol
intravenous glucoseOther
Also called Panodil
1.5 g paracetamol dissolved in 50 ml water is to be ingested orally within the first 2 minutes. Intravenous glucose is supplied in an amount to match the plasma glucose during the oral glucose tolerance test
| Study group | Role | What they receive |
|---|---|---|
| Liver transplanted | Experimental | 10 Liver transplanted patients Receives: Drug: dipeptidyl peptidase 4 (DPP4) inhibitor; Other: oral glucose; Other: intravenous glucose |
| Kidney transplanted | Experimental | 10 kidney transplanted individuals Receives: Drug: dipeptidyl peptidase 4 (DPP4) inhibitor; Other: oral glucose; Other: intravenous glucose |
| Healthy controls | Experimental | 10 healthy controls Receives: Drug: dipeptidyl peptidase 4 (DPP4) inhibitor; Other: oral glucose; Other: intravenous 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 (6)
plasma glucose
20 blood samples will be drawn during the four hours OGTT and intravenous isoglycaemic clamp, most frequently during the first hour
Measured: 20 time points within four hours
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 startJul 2009
- Primary completionAug 2012 (estimated)
- Study completionDec 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver TransplantationStudies 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01176708
- Sponsor's protocol ID
- Transplant isoglycemia (AP)
- Status last verified
- Jan 2012
- First submitted
- 5 Aug 2010
- Last updated
- 6 Jan 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Significance of Intact Liver Innervation for the Glucose and GLP-1 Induced Insulin Secretion
- ClinicalTrials.gov ID
- NCT01176708
- Acronym / sponsor ID
- Transplant isoglycemia (AP)
- Conditions
- Liver Transplantation
- Keywords
- liver transplantation, kidney transplanted, glucagon-like peptide-1, insulin secretion, vagotomy
- 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 2009
- Primary completion
- Aug 2012 (estimated)
- 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 the study is to investigate the significance of intact nerve supply to the liver for the glucagon-like peptide-1 (GLP-1) induced insulin secretion.
The hypothesis is that the effects of GLP-1 is transmitted through the GLP-1 receptor and that these effects involve sensory afferent neurons, probably primarily parasympathetic.
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.
The aim of this study is to investigate the significance of intact liver innervation for the GLP-1 induced insulin secretion in liver transplanted patients; kidney transplanted control patients matched for immunosuppressive treatment, age, gender and body weight; and ten control persons matched for age, gender and body weight.
The insulin secretion will be evaluated from blood samples that will be analyzed for insulin and c-peptide.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Liver transplanted | Experimental | Drug: dipeptidyl peptidase 4 (DPP4) inhibitor, Other: oral glucose, Other: intravenous glucose10 Liver transplanted patients |
| Kidney transplanted | Experimental | Drug: dipeptidyl peptidase 4 (DPP4) inhibitor, Other: oral glucose, Other: intravenous glucose10 kidney transplanted individuals |
| Healthy controls | Experimental | Drug: dipeptidyl peptidase 4 (DPP4) inhibitor, Other: oral glucose, Other: intravenous glucose10 healthy controls |
Who may qualify
- Ages
- 18 years and older
- 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 (DPP4) 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 | Healthy controls, Kidney transplanted, Liver transplanted |
| oral glucoseAlso: Panodil50 grams glucose dissolved in 300 ml water with 1.5 grams paracetamol | Other | Healthy controls, Kidney transplanted, Liver transplanted |
| intravenous glucoseAlso: Panodil1.5 g paracetamol dissolved in 50 ml water is to be ingested orally within the first 2 minutes. Intravenous glucose is supplied in an amount to match the plasma glucose during the oral glucose tolerance test | Other | Healthy controls, Kidney transplanted, Liver transplanted |
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
6 secondary outcomes
plasma glucose
Time frame: 20 time points within four hours
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 6 Jan 2012.
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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.
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 (DPP4) inhibitor, oral glucose and intravenous glucose in people with Liver Transplantation, 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 6 Jan 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?
Contact Astrid Plamboeck, M.D. (+45 26208174, astridp@sund.ku.dk), or a site near the patient. 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?
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 6 Jan 2012.