GLP1R Polymorphisms and Response to GLP1

This study has been completed.

Sponsor:

Collaborator:

Merck Sharp & Dohme Corp.

Information provided by (Responsible Party):

Adrian Vella, Mayo Clinic

ClinicalTrials.gov Identifier:

NCT00588380

First received: December 22, 2007

Last updated: December 14, 2011

Last verified: December 2011

History of Changes

Results First Received: April 4, 2011

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

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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
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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

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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.
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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

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1. Primary:

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

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2. Secondary:

Insulin Secretion at 210-240 Minutes [ Time Frame: 210 - 240 minutes after GLP-1 infusion ]

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Serious Adverse Events

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Other Adverse Events

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Limitations and Caveats

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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

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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:

Sathananthan A, Man CD, Micheletto F, Zinsmeister AR, Camilleri M, Giesler PD, Laugen JM, Toffolo G, Rizza RA, Cobelli C, Vella A. Common genetic variation in GLP1R and insulin secretion in response to exogenous GLP-1 in nondiabetic subjects: a pilot study. Diabetes Care. 2010 Sep;33(9):2074-6. doi: 10.2337/dc10-0200.

Responsible Party:	Adrian Vella, Mayo Clinic
ClinicalTrials.gov Identifier:	NCT00588380 History of Changes
Other Study ID Numbers:	07-004153
Study First Received:	December 22, 2007
Results First Received:	April 4, 2011
Last Updated:	December 14, 2011

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