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

History of Changes

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):

Skov J, Dejgaard A, Frøkiær 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.


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 March 02, 2015

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