GLP1R Polymorphisms and Response to GLP1 - Full Text View

Sponsors and Collaborators:	Mayo Clinic Merck
Information provided by:	Mayo Clinic
ClinicalTrials.gov Identifier:	NCT00588380

Purpose

GLP-1 is an important incretin hormone which acts as a powerful insulin secretagogue. Defects in GLP-1 synthesis and secretion are thought to be part of the pathogenesis of type 2 diabetes. Furthermore GLP-1 based therapy is an important part of the therapeutic armamentarium for the treatment of type 2 diabetes. The GLP-1 receptor is the principal site of action of GLP-1 and GLP-1 receptor agonists like exenatide and liraglutide. The gene coding for this receptor, GLP1R, is highly polymorphic and contains numerous non-synonymous SNPs (nsSNPs) which could potentially alter response to endogenous or exogenous GLP-1 or GLP-1R agonists. Indeed there is some in vitro data to support this concept. We propose to utilize a hyperglycemic clamp to test the insulin secretory response to infused GLP-1 in healthy volunteers to determine the effect of genetic variation in GLP1R on response to GLP-1

Condition	Intervention
Diabetes	Drug: GLP-1

MedlinePlus related topics: Diabetes

Drug Information available for: Glucagon-like peptide 1

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Basic Science, Open Label, Single Group Assignment
Official Title:	A Pilot Study Examining How Common Genetic Variation in GLP1R Alters Response to GLP1 Infusion

Further study details as provided by Mayo Clinic:

Primary Outcome Measures:

The focus of the analysis during the hyperglycemic clamp is the mean C-peptide concentrations at 150-180 minutes. [ Time Frame: during the study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

The secondary focus of the analysis during the hyperglycemic clamp is the mean C-peptide concentrations at 210-240 minutes. [ Time Frame: during the study ] [ Designated as safety issue: No ]

Estimated Enrollment:	100
Study Start Date:	November 2007
Estimated Study Completion Date:	November 2008
Estimated Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental All participants recieving GLP1	Drug: GLP-1 GLP-1 infused @ 0.75pmol/kg/min from 120-180 minutes, GLP-1 infused @ 1.55pmol/kg/min from 120-180 minutes,

Eligibility

Ages Eligible for Study:	18 Years to 40 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Aged 18-40
fasting glucose concentration of less than 95 mg/dl.

Exclusion Criteria:

Individuals with a BMI < 19 or > 40 kg/m2
active systemic illness
medication that can alter gastric emptying, insulin secretion & action
history of abdominal surgery (other than appendectomy or tubal ligation).

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00588380

Contacts

Contact: Paula D Giesler, RN

507-255-8345

giesler.paula@mayo.edu

Locations

United States, Minnesota
Mayo Clinic	Recruiting
Rochester, Minnesota, United States, 55905
Contact: Paula D Giesler, RN 507-255-8345 giesler.paula@mayo.edu

Sponsors and Collaborators

Mayo Clinic

Merck

Investigators

Principal Investigator:

Adrian Vella, MD

Mayo Clinic

More Information

Additional Information:

Mayo Clinic Clinical Trials This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Mayo Clinic ( Adrian Vella MD )
Study ID Numbers:	07-004153
Study First Received:	December 22, 2007
Last Updated:	December 22, 2007
ClinicalTrials.gov Identifier:	NCT00588380 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Mayo Clinic:

GLP-1
Insulin Secretion

Study placed in the following topic categories:

Diabetes Mellitus
Insulin
Glucagon-Like Peptide 1

ClinicalTrials.gov processed this record on May 07, 2009