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GLP1R Polymorphisms and Response to GLP1

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: NCT00588380
Recruitment Status : Completed
First Posted : January 8, 2008
Results First Posted : December 6, 2011
Last Update Posted : December 19, 2011
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Adrian Vella, Mayo Clinic

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Basic Science
Condition: Diabetes
Intervention: Drug: GLP-1

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Healthy volunteers recruited from Olmsted County, MN.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Overall Study All participants recieved glucose for 2 hours then Glucagon Like Peptide-1 (GLP-1) intravenously at a rate of 0.75 pmol/kg/min for 1 hour followed by 1.5 pmol/kg/min for the subsequent hour. The study lasted for 240 minutes.

Participant Flow:   Overall Study
    Overall Study
STARTED   88 
COMPLETED   88 
NOT COMPLETED   0 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Overall Study All participants recieved glucose for 2 hours then Glucagon Like Peptide-1 (GLP-1) intravenously at a rate of 0.75 pmol/kg/min for 1 hour followed by 1.5 pmol/kg/min for the subsequent hour. The study lasted for 240 minutes.

Baseline Measures
   Overall Study 
Overall Participants Analyzed 
[Units: Participants]
 		 88 
Age 
[Units: Years]
Mean (Standard Deviation) 		 26.3  (5.6) 
Gender 
[Units: Participants]
 		 
Female   52 
Male   36 
Region of Enrollment 
[Units: Participants]
 		 
United States   88 


  Outcome Measures

1.  Primary:   Insulin Secretion at 150-180 Minutes.   [ Time Frame: 150 - 180 minutes after GLP-1 infusion ]
  Show Outcome Measure 1

2.  Secondary:   Insulin Secretion at 210-240 Minutes   [ Time Frame: 210 - 240 minutes after GLP-1 infusion ]
  Show Outcome Measure 2


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
This is a pilot study with limited power to detect / replicate effects. It will require independent replication of study results.


  More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Adrian Vella
Organization: Mayo Clinic
phone: 507-284-3754
e-mail: vella.adrian@mayo.edu


Publications of Results:


Responsible Party: Adrian Vella, Mayo Clinic
ClinicalTrials.gov Identifier: NCT00588380     History of Changes
Other Study ID Numbers: 07-004153
First Submitted: December 22, 2007
First Posted: January 8, 2008
Results First Submitted: April 4, 2011
Results First Posted: December 6, 2011
Last Update Posted: December 19, 2011