NCT02104037

Brief Summary

The purpose of this study is to investigate transfer of liraglutide from blood to cerebrospinal fluid.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
8

participants targeted

Target at below P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

January 1, 2012

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

April 1, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 4, 2014

Completed
Last Updated

April 4, 2014

Status Verified

April 1, 2014

Enrollment Period

1.9 years

First QC Date

April 1, 2014

Last Update Submit

April 3, 2014

Conditions

Liraglutide Blood-brain Transfer

Outcome Measures

Primary Outcomes (1)

  • cerebrospinal fluid concentration of liraglutide

    time 60 minutes

Study Arms (1)

Liraglutide treated patients

EXPERIMENTAL
Procedure: Lumbar puncture

Interventions

Lumbar puncturePROCEDURE
Liraglutide treated patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Type 2 diabetes treated with liraglutide 1.8 mg for 1 month and 5% weight loss

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Diabetes Research Division, Department of Medicine

Hellerup, 2900, Denmark

Location

MeSH Terms

Interventions

Spinal Puncture

Intervention Hierarchy (Ancestors)

BiopsySpecimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisDiagnostic Techniques, NeurologicalPuncturesTherapeuticsSurgical Procedures, OperativeInvestigative Techniques

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Dr.

Study Record Dates

First Submitted

April 1, 2014

First Posted

April 4, 2014

Study Start

January 1, 2012

Primary Completion

December 1, 2013

Last Updated

April 4, 2014

Record last verified: 2014-04

Locations

DK(1)