GLP1R Polymorphisms and Response to GLP1

Not Applicable

Completed

• Conditions: Diabetes
• Interventions: Drug: GLP-1

• Registration Number: NCT00588380
• Lead Sponsor: Mayo Clinic

Brief Summary

Glucagon-like Peptide-1 (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 (GLP1R) 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 Single Nucleotide Polymorphisms (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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-11
• Study First Submitted: 2007-12-22
• Study First Submitted QC: 2007-12-22
• Study First Posted: 2008-01-08
• Primary Completion: 2010-09
• Study Completion: 2010-09
• Results First Submitted: 2011-04-04
• Results First Submitted QC: 2011-11-01
• Status Verified: 2011-12
• Results First Posted: 2011-12-06
• Last Update Submitted: 2011-12-14
• Last Update Posted: 2011-12-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 88

Inclusion Criteria

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

Exclusion Criteria

• Individuals with a BMI < 19 or > 40 kg/m^2
• active systemic illness
• medication that can alter gastric emptying, insulin secretion & action
• history of abdominal surgery (other than appendectomy or tubal ligation).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
GLP-1	GLP-1	All participants recieved GLP-1 intravenously at 0.75 pmol/kg/min for the first hour and then at 1.5 pmol/kg/min for the next hour

Primary Outcome Measures

Name	Time	Method
Insulin Secretion at 150-180 Minutes.	150 - 180 minutes after GLP-1 infusion	The 180 minute value represents the mean of the values obtained at 150, 160, 170, and 180 minutes.

Secondary Outcome Measures

Name	Time	Method
Insulin Secretion at 210-240 Minutes	210 - 240 minutes after GLP-1 infusion	The 240 minute value represents the mean of values obtained at 210, 220, 230, and 240 minutes.

Trial Locations

Locations (1)

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States