GLP-1: Acute Effects on Kidney Function in Healthy Men

This study has been completed.
Sponsor:
Collaborator:
Novo Nordisk A/S
Information provided by (Responsible Party):
Jeppe Skov, University of Aarhus
ClinicalTrials.gov Identifier:
NCT01333163
First received: April 8, 2011
Last updated: December 14, 2011
Last verified: December 2011
  Purpose

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.


Condition Intervention
Kidney Functional
Biological: Human GLP-1 (7-36) amide
Biological: Isotone NaCl

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Basic Science
Official Title: GLP-1: Acute Effects on Kidney Function in Healthy Men

Further study details as provided by University of Aarhus:

Primary Outcome Measures:
  • Glomerular Filtration Rate [ Time Frame: Every 20 minutes for 6 hours ] [ Designated as safety issue: No ]

Enrollment: 12
Study Start Date: May 2011
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: GLP-1 Biological: Human GLP-1 (7-36) amide
2 hour IV infusion, 1,5pmol/min/kg.
Placebo Comparator: Placebo Biological: Isotone NaCl
2 hours IV infusion.

  Eligibility

Ages Eligible for Study:   18 Years to 30 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy young men

Exclusion Criteria:

  • Any chronic diseases
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01333163

Locations
Denmark
Klinisk Institut, Afd. MEA, Aarhus Sygehus, NBG
Aarhus C, Denmark, 8000
Sponsors and Collaborators
Jeppe Skov
Novo Nordisk A/S
Investigators
Principal Investigator: Jeppe Skov, MD University of Aarhus
  More Information

No publications provided by University of Aarhus

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Jeppe Skov, MD, University of Aarhus
ClinicalTrials.gov Identifier: NCT01333163     History of Changes
Other Study ID Numbers: VEKRM 29414
Study First Received: April 8, 2011
Last Updated: December 14, 2011
Health Authority: Denmark: The Regional Committee on Biomedical Research Ethics
Denmark: Danish Dataprotection Agency

ClinicalTrials.gov processed this record on April 17, 2014