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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 October 21, 2014