GLP1R Polymorphisms and Response to GLP1
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Diabetes |
Drug: GLP-1 |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Basic Science |
| Official Title: | A Pilot Study Examining How Common Genetic Variation in GLP1R Alters Response to GLP1 Infusion |
- Insulin Secretion at 150-180 Minutes. [ Time Frame: 150 - 180 minutes after GLP-1 infusion ] [ Designated as safety issue: No ]The 180 minute value represents the mean of the values obtained at 150, 160, 170, and 180 minutes.
- Insulin Secretion at 210-240 Minutes [ Time Frame: 210 - 240 minutes after GLP-1 infusion ] [ Designated as safety issue: No ]The 240 minute value represents the mean of values obtained at 210, 220, 230, and 240 minutes.
| Enrollment: | 88 |
| Study Start Date: | November 2007 |
| Study Completion Date: | September 2010 |
| Primary Completion Date: | September 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 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
|
Drug: GLP-1
GLP-1 infused at 0.75 pmol/kg/min from 121-180 minutes, GLP-1 infused at 1.55 pmol/kg/min from 181-240 minutes,
|
Eligibility| Ages Eligible for Study: | 18 Years to 40 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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).
Contacts and Locations More Information
Additional Information:
Publications:
| Responsible Party: | Adrian Vella, Professor of Medicine, 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 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Mayo Clinic:
|
GLP-1 Insulin Secretion |
Additional relevant MeSH terms:
|
Glucagon-Like Peptide 1 Incretins Hormones |
Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 23, 2013