The Focus of This Study is to Evaluete the Significances of the Vagal Cholinerg Nervuos System for the Effect of GLP-1 by Using Atropin Administration.NCT01534442
Atropin and Glucose Stimulated Insulinsecretion and the Cephalic Insulin Response
A study testing Atropine in people with The Focus of This Study is to Evaluete the Significances of the Vagal Cholinerg Nervuos System for the Effect of GLP-1 by Using Atropin Administration., run by University Hospital, Gentofte, Copenhagen at 2 sites in Denmark.
Trial summary
The aim of this study is to investigate the role of transmission of vagal cholinerg for the GLP-1 potentiation of the glucose stimulated insulin secretion and the cephalic insulin response by using atropin administration. Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- The Focus of This Study is to Evaluete the Significances of the Vagal Cholinerg Nervuos System for the Effect of GLP-1 by Using Atropin Administration.
- What is being tested?
- Atropine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 2 sitesDenmark
- Study dates
- Sep 2011to 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 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- age between 18 and 45 years
- normal fasting plasma glucose
- normal hemoglobin
- informed consent
Who cannot join
- diabetes mellitus
- body mass index above 30
- inflamatoric bowel disease
- intestinal surgery
- serum creatinine above 250 microM
- ALAT above to times normal value
- treatment with medicine wich cannot be paused for 12 hours
- contraindication for treatment with atropin
Trial locations and contacts
2 sites in 1 country.
Denmark2 sites, 2 recruiting
- Recruiting
Diabetes research Division, Department of Internal Medicin, Gentofte Hospital
Hellerup, 2900
Astrid Plamboeck, MD, +45 26208174, astridp@sund.ku.dk
Tina Vilsbøll, MD, Dr. med, +45 40940825, t.vilsboll@dadlnet.dk
- Recruiting
Diabetes Research Division, Department of Internal Medicine, Gentofte Hospital, Copenhagen Denmark
Hellerup, 2900
Astrid Plamboeck, MD, +45 26208174, astridp@sund.ku.dk
Astrid Plamboeck, MD
About this study
Official title: The Significances of Atropin Administration for the GLP-1 Potentiation of Glucose Induced Insulin Secretion and the Cephalic Insulin Response
The aim of this study is to investigate the role of transmission of vagal cholinerg for the GLP-1 potentiation of the glucose stimulated insulin secretion and the cephalic insulin response by using atropin administration.
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 an intact nervous supply with and without atropin administration.
Read the detailed description
GLP-1 is a importent enterogastron and incretin hormone. Rapid degradation of GLP-1 by dipeptidyl peptidase 4 (DPP-4) suggests that GLP-1 may act locally (through vagal afferents) before being degraded. We aimed to clarify the role of vagal innervation on the incretin effect.
- Being tested
- Atropine, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AtropineDrug
1 mg as a bolus and the and infusion of 80 ng/kg/min for either 105 or 145 minuts.
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Atropin | Active comparator | Atropin Receives: Drug: Atropine |
| Placebo | Placebo comparator | Saline Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
insulin secretion
The insulin secretion during lightly elevated blood glucose during GLP-1 infusions with and without atropin administration is evaluated. Also the insulin secretion during lightly elevated blood glucose during a sham-feeding with and without atropin administration is evaluated.
Measured: tree hours
Secondary outcomes (8)
Plasma PP
20 blood samlpes will be drawn during lightly elevated blood glucose during a sham-feeding with and without atropin administration.
Measured: 20 time points within tree hours
Plasma glucose
30 blood samlpes will be drawn during lightly elevated blood glucose during a sham-feeding with and without atropin administration.
Measured: 30 within tree hours
Plasma GLP-1
20 blood samlpes will be drawn during lightly elevated blood glucose during a sham-feeding with and without atropin administration.
Measured: 20 time points within tree hours
Plasma GLP-1
18 blood samples will be drawn during lightly elevated blood glucose during GLP-1 infusions with and without atropin administration.
Measured: 18 time points within tree hours
Plasma GLP-2
18 blood samples will be drawn during lightly elevated blood glucose during GLP-1 infusions with and without atropin administration.
Measured: 18 time points within tree hours
Plasma GIP
18 blood samples will be drawn during lightly elevated blood glucose during GLP-1 infusions with and without atropin administration.
Measured: 18 timepoints within tree hours
Plasma glucagon
18 blood samples will be drawn during lightly elevated blood glucose during GLP-1 infusions with and without atropin administration.
Measured: 18 timepoints within tree hours
Plasma glucose
33 blood samples will be drawn during lightly elevated blood glucose during GLP-1 infusions with and without atropin administration.
Measured: 33 timepoints within tree hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2012 (estimated)
- Study startSep 2011
- Primary completionDec 2012 (estimated)
- 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 The Focus of This Study is to Evaluete the Significances of the Vagal Cholinerg Nervuos System for the Effect of GLP-1 by Using Atropin Administration.Studies 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
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 10 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
- Tina Vilsbøll, MD, Dr. med, Study director, Diabetes research Division, Department of Internal Medicine, Gentofte Hospital, Copenhagen, Denamrk
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01534442
- Sponsor's protocol ID
- Atropin clamp
- Status last verified
- Dec 2012
- First submitted
- 13 Feb 2012
- Last updated
- 7 Dec 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Veedfald S, Plamboeck A, Deacon CF, Hartmann B, Knop FK, Vilsboll T, Holst JJ. Cephalic phase secretion of insulin and other enteropancreatic hormones in humans. Am J Physiol Gastrointest Liver Physiol. 2016 Jan 1;310(1):G43-51. doi: 10.1152/ajpgi.00222.2015. Epub 2015 Oct 22.
PubMed 26492921Plamboeck A, Veedfald S, Deacon CF, Hartmann B, Vilsboll T, Knop FK, Holst JJ. The role of efferent cholinergic transmission for the insulinotropic and glucagonostatic effects of GLP-1. Am J Physiol Regul Integr Comp Physiol. 2015 Sep;309(5):R544-51. doi: 10.1152/ajpregu.00123.2015. Epub 2015 Jul 1.
PubMed 26136531
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 Atropin Administration for the GLP-1 Potentiation of Glucose Induced Insulin Secretion and the Cephalic Insulin Response
- ClinicalTrials.gov ID
- NCT01534442
- Acronym / sponsor ID
- Atropin clamp
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- University Hospital, Gentofte, CopenhagenUniversity, hospital or other
- Collaborators
- University of Copenhagen
- Study start
- Sep 2011
- Primary completion
- Dec 2012 (estimated)
- Study completion
- Dec 2012 (estimated)
- First posted
- 16 Feb 2012 (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 of vagal cholinerg for the GLP-1 potentiation of the glucose stimulated insulin secretion and the cephalic insulin response by using atropin administration.
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 an intact nervous supply with and without atropin administration.
Detailed description
GLP-1 is a importent enterogastron and incretin hormone. Rapid degradation of GLP-1 by dipeptidyl peptidase 4 (DPP-4) suggests that GLP-1 may act locally (through vagal afferents) before being degraded. We aimed to clarify the role of vagal innervation on the incretin effect.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Atropin | Active comparator | Drug: AtropineAtropin |
| Placebo | Placebo comparator | Drug: PlaceboSaline |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- age between 18 and 45 years
- normal fasting plasma glucose
- normal hemoglobin
- informed consent
Key exclusion criteria (8 listed)
- diabetes mellitus
- body mass index above 30
- inflamatoric bowel disease
- intestinal surgery
- serum creatinine above 250 microM
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 |
|---|---|---|
| Atropine1 mg as a bolus and the and infusion of 80 ng/kg/min for either 105 or 145 minuts. | Drug | Atropin |
| Placebo | Drug | Placebo |
Primary outcome
insulin secretion
Time frame: tree hours
The insulin secretion during lightly elevated blood glucose during GLP-1 infusions with and without atropin administration is evaluated. Also the insulin secretion during lightly elevated blood glucose during a sham-feeding with and without atropin administration is evaluated.
8 secondary outcomes
Plasma PP
Time frame: 20 time points within tree hours
Plasma glucose
Time frame: 30 within tree hours
Plasma GLP-1
Time frame: 20 time points within tree hours
Plasma GLP-1
Time frame: 18 time points within tree hours
Plasma GLP-2
Time frame: 18 time points within tree hours
Plasma GIP
Time frame: 18 timepoints within tree hours
Plasma glucagon
Time frame: 18 timepoints within tree hours
Plasma glucose
Time frame: 33 timepoints within tree 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 26492921Veedfald S, Plamboeck A, Deacon CF, Hartmann B, Knop FK, Vilsboll T, Holst JJ. Cephalic phase secretion of insulin and other enteropancreatic hormones in humans. Am J Physiol Gastrointest Liver Physiol. 2016 Jan 1;310(1):G43-51. doi: 10.1152/ajpgi.00222.2015. Epub 2015 Oct 22.
- Derived from this study: PubMed 26136531Plamboeck A, Veedfald S, Deacon CF, Hartmann B, Vilsboll T, Knop FK, Holst JJ. The role of efferent cholinergic transmission for the insulinotropic and glucagonostatic effects of GLP-1. Am J Physiol Regul Integr Comp Physiol. 2015 Sep;309(5):R544-51. doi: 10.1152/ajpregu.00123.2015. Epub 2015 Jul 1.
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.
Tina Vilsbøll, MD, Dr. med study director
Diabetes research Division, Department of Internal Medicine, Gentofte Hospital, Copenhagen, Denamrk
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Atropine in people with The Focus of This Study is to Evaluete the Significances of the Vagal Cholinerg Nervuos System for the Effect of GLP-1 by Using Atropin Administration., run by University Hospital, Gentofte, Copenhagen at 2 sites 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 4 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 2 sites 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. 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.
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, MD (+ 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: tree 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 NCT01534442, 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.