NCT01333163

Brief Summary

The purpose of this study is to investigate how Glucagon-Like Peptide 1 (GLP-1) affects kidney function in healthy young men. The hypothesis is that GLP-1 induces a positive effect on kidney hemodynamics.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2011

Shorter than 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

First Submitted

Initial submission to the registry

April 8, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 11, 2011

Completed
20 days until next milestone

Study Start

First participant enrolled

May 1, 2011

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

December 15, 2011

Status Verified

December 1, 2011

Enrollment Period

7 months

First QC Date

April 8, 2011

Last Update Submit

December 14, 2011

Conditions

Kidney Functional

Outcome Measures

Primary Outcomes (1)

  • Glomerular Filtration Rate

    Every 20 minutes for 6 hours

Study Arms (2)

GLP-1

ACTIVE COMPARATOR
Biological: Human GLP-1 (7-36) amide

Placebo

PLACEBO COMPARATOR
Biological: Isotone NaCl

Interventions

Human GLP-1 (7-36) amideBIOLOGICAL

2 hour IV infusion, 1,5pmol/min/kg.

GLP-1
Isotone NaClBIOLOGICAL

2 hours IV infusion.

Placebo

Eligibility Criteria

Age18 Years - 30 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy young men

You may not qualify if:

  • Any chronic diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Klinisk Institut, Afd. MEA, Aarhus Sygehus, NBG

Aarhus C, 8000, Denmark

Location

Related Publications (1)

  • Skov J, Dejgaard A, Frokiaer J, Holst JJ, Jonassen T, Rittig S, Christiansen JS. Glucagon-like peptide-1 (GLP-1): effect on kidney hemodynamics and renin-angiotensin-aldosterone system in healthy men. J Clin Endocrinol Metab. 2013 Apr;98(4):E664-71. doi: 10.1210/jc.2012-3855. Epub 2013 Mar 5.

    PMID: 23463656DERIVED

MeSH Terms

Interventions

Amides

Intervention Hierarchy (Ancestors)

Organic Chemicals

Study Officials

  • Jeppe Skov, MD

    University of Aarhus

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

April 8, 2011

First Posted

April 11, 2011

Study Start

May 1, 2011

Primary Completion

December 1, 2011

Study Completion

December 1, 2011

Last Updated

December 15, 2011

Record last verified: 2011-12

Locations

DK(1)