NCT01534442

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2011

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2011

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

February 13, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 16, 2012

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

December 7, 2012

Status Verified

December 1, 2012

Enrollment Period

1.3 years

First QC Date

February 13, 2012

Last Update Submit

December 6, 2012

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.

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (8)

  • Plasma PP

    20 time points within tree hours

  • Plasma glucose

    30 within tree hours

  • Plasma GLP-1

    20 time points within tree hours

  • Plasma GLP-1

    18 time points within tree hours

  • Plasma GLP-2

    18 time points within tree hours

  • +3 more secondary outcomes

Study Arms (2)

Atropin

ACTIVE COMPARATOR

Atropin

Drug: Atropine

Placebo

PLACEBO COMPARATOR

Saline

Drug: Placebo

Interventions

AtropineDRUG

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

Atropin
PlaceboDRUG
Placebo

Eligibility Criteria

Age18 Years - 45 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • age between 18 and 45 years
  • normal fasting plasma glucose
  • normal hemoglobin
  • informed consent

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Diabetes research Division, Department of Internal Medicin, Gentofte Hospital

Hellerup, 2900, Denmark

RECRUITING

Diabetes Research Division, Department of Internal Medicine, Gentofte Hospital, Copenhagen Denmark

Hellerup, 2900, Denmark

RECRUITING

Related Publications (2)

  • 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.

    PMID: 26492921DERIVED

  • 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.

    PMID: 26136531DERIVED

MeSH Terms

Interventions

Atropine

Intervention Hierarchy (Ancestors)

Atropine DerivativesTropanesAzabicyclo CompoundsAza CompoundsOrganic ChemicalsBelladonna AlkaloidsSolanaceous AlkaloidsAlkaloidsHeterocyclic CompoundsBridged Bicyclo Compounds, HeterocyclicHeterocyclic Compounds, Bridged-Ring

Study Officials

  • Tina Vilsbøll, MD, Dr. med

    Diabetes research Division, Department of Internal Medicine, Gentofte Hospital, Copenhagen, Denamrk

    STUDY DIRECTOR

Central Study Contacts

Astrid Plamboeck, MD

CONTACT

+ 45 26208174astridp@sund.ku.dk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

February 13, 2012

First Posted

February 16, 2012

Study Start

September 1, 2011

Primary Completion

December 1, 2012

Study Completion

December 1, 2012

Last Updated

December 7, 2012

Record last verified: 2012-12

Locations

DK(2)