Clinical trial NCT01534442: Atropin and Glucose Stimulated Insulinsecretion and the Cephalic Insulin Response
Official title: The Significances of Atropin Administration for the GLP-1 Potentiation of Glucose Induced Insulin Secretion and the Cephalic Insulin Response
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: 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.
Lead sponsor: University Hospital, Gentofte, Copenhagen
Sponsor class: OTHER
Collaborators: name: University of Copenhagen
First posted: 2012-02-16
Enrollment: 10
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: insulin secretion
timeFrame: tree hours
Secondary outcomes:
measure: Plasma PP
timeFrame: 20 time points within tree hours
measure: Plasma glucose
timeFrame: 30 within tree hours
measure: Plasma GLP-1
timeFrame: 20 time points within tree hours
measure: Plasma GLP-1
timeFrame: 18 time points within tree hours
measure: Plasma GLP-2
timeFrame: 18 time points within tree hours
measure: Plasma GIP
timeFrame: 18 timepoints within tree hours
measure: Plasma glucagon
timeFrame: 18 timepoints within tree hours
measure: Plasma glucose
timeFrame: 33 timepoints within tree hours
Other outcomes:
Locations:
city: Hellerup
country: Denmark
facility: Diabetes research Division, Department of Internal Medicin, Gentofte Hospital
city: Hellerup
country: Denmark
facility: Diabetes Research Division, Department of Internal Medicine, Gentofte Hospital, Copenhagen Denmark
Study officials:
affiliation: Diabetes research Division, Department of Internal Medicine, Gentofte Hospital, Copenhagen, Denamrk
name: Tina Vilsbøll, MD, Dr. med
role: STUDY_DIRECTOR
References:
citation: 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.
citation: Plamboeck 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.