ClinicalTrials.gov
ClinicalTrials.gov Menu

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
Enrollment 88
Recruitment Details Healthy volunteers recruited from Olmsted County, MN.
Pre-assignment Details  
Arm/Group Title Overall Study
Hide Arm/Group Description 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.
Period Title: Overall Study
Started 88
Completed 88
Not Completed 0
Arm/Group Title Overall Study
Hide Arm/Group Description 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.
Overall Number of Baseline Participants 88
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 88 participants
26.3  (5.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 88 participants
Female
52
  59.1%
Male
36
  40.9%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 88 participants
88
1.Primary Outcome
Title Insulin Secretion at 150-180 Minutes.
Hide Description The 180 minute value represents the mean of the values obtained at 150, 160, 170, and 180 minutes.
Time Frame 150 - 180 minutes after GLP-1 infusion
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
all participants completed the study
Arm/Group Title All Participants
Hide Arm/Group Description:
C-peptide as a marker of insulin secretion
Overall Number of Participants Analyzed 88
Mean (Standard Error)
Unit of Measure: 10^-9 min^-1
rs6923761 (1,1) genotype 104  (9)
rs6923761 (1, 2) genotype 94  (11)
rs6923761 (2, 2) genotype 81  (8)
rs3765467 (1,2) genotype 92  (6)
rs3765467 (2,2) genotype 219  (35)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection All Participants
Comments Using the Kruskal-Wallis test (general allelic model), we assessed univariate associations of rs6923761 genotype with Phi Total in the presence of either glucose alone, glucose and 0.75 pmol/kg/min GLP-1 or glucose and 1.5 pmol/kg/min GLP-1 If the p-value for the overall univariate test of association was <0.1, then the associations for specific genotype pairs (e.g.: 1,1 vs. 1,2 or 2,2 vs. 1,1) were also examined using a Mann-Whitney Rank Sum test.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.11
Comments [Not Specified]
Method Kruskal-Wallis
Comments [Not Specified]
2.Secondary Outcome
Title Insulin Secretion at 210-240 Minutes
Hide Description The 240 minute value represents the mean of values obtained at 210, 220, 230, and 240 minutes.
Time Frame 210 - 240 minutes after GLP-1 infusion
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants completing the study.
Arm/Group Title Overall Study
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 88
Mean (Standard Error)
Unit of Measure: 10^-9 min^-1
rs6923761 (1,1) genotype 152  (12)
rs6923761 (1,2) genotype 133  (15)
rs6923761 (2,2) genotype 112  (10)
rs3765467 (1,2) genotype 132  (7)
rs3765467 (2,2) genotype 325  (44)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Overall Study
Comments All data are presented as means ± SEM. Using the Kruskal-Wallis test (general allelic model), we assessed univariate associations of genotype with ΦTotal
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.09
Comments [Not Specified]
Method Kruskal-Wallis
Comments [Not Specified]
Time Frame Duration of the study (4 hours)
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Overall Study
Hide Arm/Group Description 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.
All-Cause Mortality
Overall Study
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Overall Study
Affected / at Risk (%)
Total   0/88 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Overall Study
Affected / at Risk (%)
Total   0/88 (0.00%) 
This is a pilot study with limited power to detect / replicate effects. It will require independent replication of study results.
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
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