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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

Tracking Information
First Submitted Date  ICMJE April 8, 2011
First Posted Date  ICMJE April 11, 2011
Last Update Posted Date December 15, 2011
Study Start Date  ICMJE May 2011
Actual Primary Completion Date December 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 8, 2011)
Glomerular Filtration Rate [ Time Frame: Every 20 minutes for 6 hours ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE GLP-1: Acute Effects on Kidney Function in Healthy Men
Official Title  ICMJE GLP-1: Acute Effects on Kidney Function in Healthy Men
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Condition  ICMJE Kidney Functional
Intervention  ICMJE
  • Biological: Human GLP-1 (7-36) amide
    2 hour IV infusion, 1,5pmol/min/kg.
  • Biological: Isotone NaCl
    2 hours IV infusion.
Study Arms  ICMJE
  • Active Comparator: GLP-1
    Intervention: Biological: Human GLP-1 (7-36) amide
  • Placebo Comparator: Placebo
    Intervention: Biological: Isotone NaCl
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 8, 2011)
12
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2011
Actual Primary Completion Date December 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Healthy young men

Exclusion Criteria:

  • Any chronic diseases
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years to 30 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Denmark
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01333163
Other Study ID Numbers  ICMJE VEKRM 29414
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Jeppe Skov, University of Aarhus
Study Sponsor  ICMJE Jeppe Skov
Collaborators  ICMJE Novo Nordisk A/S
Investigators  ICMJE
Principal Investigator: Jeppe Skov, MD University of Aarhus
PRS Account University of Aarhus
Verification Date December 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP