NCT01988545

Brief Summary

to investigate the effect of the human incretin hormone GLP-1 on mesenteric blood flow and cardiac parameters

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
8

participants targeted

Target at below P25 for not_applicable healthy

Timeline
Completed

Started Nov 2013

Typical duration for not_applicable healthy

Geographic Reach
1 country

1 active site

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

November 1, 2013

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

November 13, 2013

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 20, 2013

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

November 20, 2013

Status Verified

November 1, 2013

Enrollment Period

7 months

First QC Date

November 13, 2013

Last Update Submit

November 19, 2013

Conditions

Healthy

Keywords

GLP-1blood flowcardiac out putstroke volumebeat to beateffect of GLP-1 on cardiac parameters and blood flow

Outcome Measures

Primary Outcomes (1)

  • blood flow

    blood flow change measured by ultra sound

    with in 120 minutes

Other Outcomes (1)

  • cardiac parameters

    with in 120 minutes

Study Arms (4)

GLP-1

ACTIVE COMPARATOR

1,5 nmol/kg,GLP-1 sc injection

Other: 1,5 nmol/kg GLP-1 9-36amide, sc injectionOther: Exendin-4 ;10 ug,sc injection

GLP-1 9-36amide

ACTIVE COMPARATOR

1,5 nmol/kg GLP-1 9-36amide, sc injection

Other: 1,5 nmol/kg,GLP-1 sc injectionOther: Exendin-4 ;10 ug,sc injection

Exendin-4

ACTIVE COMPARATOR

Exendin-4 ;10 ug,sc injection

Other: 1,5 nmol/kg,GLP-1 sc injectionOther: 1,5 nmol/kg GLP-1 9-36amide, sc injection

isotonic saline

PLACEBO COMPARATOR

2 ml of isotonic saline, sc injection

Other: 1,5 nmol/kg,GLP-1 sc injectionOther: 1,5 nmol/kg GLP-1 9-36amide, sc injectionOther: saline

Interventions

1,5 nmol/kg,GLP-1 sc injectionOTHER
Also known as: native GLP-1
Exendin-4GLP-1 9-36amideisotonic saline
1,5 nmol/kg GLP-1 9-36amide, sc injectionOTHER
Exendin-4GLP-1isotonic saline
Exendin-4 ;10 ug,sc injectionOTHER
GLP-1GLP-1 9-36amide
salineOTHER
isotonic saline

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • healthy subjects

You may not qualify if:

  • medical conditions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Køge Hospital

Køge, State..., 4600, Denmark

RECRUITING

MeSH Terms

Interventions

Sodium Chloride

Intervention Hierarchy (Ancestors)

ChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Study Officials

  • Lasse Bremholm, MD, ph.d.

    Køge Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Lasse Bremholm, MD, ph.d.

CONTACT

0004560927874lassebremholm@dadlnet.dk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, ass. professor, ph.d

Study Record Dates

First Submitted

November 13, 2013

First Posted

November 20, 2013

Study Start

November 1, 2013

Primary Completion

June 1, 2014

Study Completion

December 1, 2014

Last Updated

November 20, 2013

Record last verified: 2013-11

Locations

DK(1)