ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01333163
Recruitment Status : Completed
First Posted : April 11, 2011
Last Update Posted : December 15, 2011
Sponsor:
Collaborator:
Novo Nordisk A/S
Information provided by (Responsible Party):
Jeppe Skov, University of Aarhus

Study Description
Go to 
Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
Kidney Functional Biological: Human GLP-1 (7-36) amide Biological: Isotone NaCl Not Applicable

Study Design
Go to 
Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Official Title: GLP-1: Acute Effects on Kidney Function in Healthy Men
Study Start Date : May 2011
Actual Primary Completion Date : December 2011
Actual Study Completion Date : December 2011
Arms and Interventions
Go to 
Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
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.


Outcome Measures
Go to 
Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Glomerular Filtration Rate [ Time Frame: Every 20 minutes for 6 hours ]

Eligibility Criteria
Go to 
Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 30 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy young men

Exclusion Criteria:

  • Any chronic diseases
Contacts and Locations
Go to 
Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
Go to 
Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
First Posted: April 11, 2011    Key Record Dates
Last Update Posted: December 15, 2011
Last Verified: December 2011

Additional relevant MeSH terms:
Glucagon-Like Peptide 1
Glucagon
Incretins
Hormones
 Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Gastrointestinal Agents