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Completed

NCT Number: NCT00588380

GLP1R Polymorphisms and Response to GLP1

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.

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Key information

Conditions

Diabetes Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

GLP-1

Drug

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,

Primary outcomes

  1. Insulin Secretion at 150-180 Minutes.

    Time frame: 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 outcomes

  1. Insulin Secretion at 210-240 Minutes

    Time frame: 210 - 240 minutes after GLP-1 infusion

    The 240 minute value represents the mean of values obtained at 210, 220, 230, and 240 minutes.

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Collaborators

  • Merck Sharp & Dohme LLC

Registry information

Official study title

A Pilot Study Examining How Common Genetic Variation in GLP1R Alters Response to GLP1 Infusion

Important dates

Study start
2007
Primary completion
2010
Study completion
2010
First posted
Jan 8, 2008
Registry last updated
Dec 19, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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