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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
  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

Resource links provided by NLM:


Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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
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/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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Merck Sharp & Dohme Corp.
Investigators
Principal Investigator: Adrian Vella, MD Mayo Clinic
  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
Glucagon-Like Peptide 1
Gastrointestinal Agents
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Incretins
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014