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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT01534442
Other study ID # Atropin clamp
Secondary ID
Status Recruiting
Phase N/A
First received February 13, 2012
Last updated December 6, 2012
Start date September 2011
Est. completion date December 2012

Study information

Verified date December 2012
Source University Hospital, Gentofte, Copenhagen
Contact Astrid Plamboeck, MD
Phone + 45 26208174
Email astridp@sund.ku.dk
Is FDA regulated No
Health authority Denmark: The Danish Dataprotection Agency
Study type Interventional

Clinical 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.

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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 10
Est. completion date December 2012
Est. primary completion date December 2012
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years to 45 Years
Eligibility Inclusion Criteria:

- age between 18 and 45 years

- normal fasting plasma glucose

- normal hemoglobin

- informed consent

Exclusion Criteria:

- 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

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Subject), Primary Purpose: Basic Science


Related Conditions & MeSH terms

  • 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.

Intervention

Drug:
Atropine
1 mg as a bolus and the and infusion of 80 ng/kg/min for either 105 or 145 minuts.
Placebo


Locations

Country Name City State
Denmark Diabetes research Division, Department of Internal Medicin, Gentofte Hospital Hellerup
Denmark Diabetes Research Division, Department of Internal Medicine, Gentofte Hospital, Copenhagen Denmark Hellerup

Sponsors (2)

Lead Sponsor Collaborator
University Hospital, Gentofte, Copenhagen University of Copenhagen

Country where clinical trial is conducted

Denmark, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. tree hours No
Secondary Plasma PP 20 blood samlpes will be drawn during lightly elevated blood glucose during a sham-feeding with and without atropin administration. 20 time points within tree hours No
Secondary Plasma glucose 30 blood samlpes will be drawn during lightly elevated blood glucose during a sham-feeding with and without atropin administration. 30 within tree hours No
Secondary Plasma GLP-1 20 blood samlpes will be drawn during lightly elevated blood glucose during a sham-feeding with and without atropin administration. 20 time points within tree hours No
Secondary Plasma GLP-1 18 blood samples will be drawn during lightly elevated blood glucose during GLP-1 infusions with and without atropin administration. 18 time points within tree hours No
Secondary Plasma GLP-2 18 blood samples will be drawn during lightly elevated blood glucose during GLP-1 infusions with and without atropin administration. 18 time points within tree hours No
Secondary Plasma GIP 18 blood samples will be drawn during lightly elevated blood glucose during GLP-1 infusions with and without atropin administration. 18 timepoints within tree hours No
Secondary Plasma glucagon 18 blood samples will be drawn during lightly elevated blood glucose during GLP-1 infusions with and without atropin administration. 18 timepoints within tree hours No
Secondary Plasma glucose 33 blood samples will be drawn during lightly elevated blood glucose during GLP-1 infusions with and without atropin administration. 33 timepoints within tree hours No