NCT00588380

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
88

participants targeted

Target at P25-P50 for not_applicable diabetes

Timeline
Completed

Started Nov 2007

Typical duration for not_applicable diabetes

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2007

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 22, 2007

Completed
17 days until next milestone

First Posted

Study publicly available on registry

January 8, 2008

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2010

Completed
1.3 years until next milestone

Results Posted

Study results publicly available

December 6, 2011

Completed
Last Updated

December 19, 2011

Status Verified

December 1, 2011

Enrollment Period

2.8 years

First QC Date

December 22, 2007

Results QC Date

April 4, 2011

Last Update Submit

December 14, 2011

Conditions

Diabetes

Keywords

GLP-1Insulin Secretion

Outcome Measures

Primary Outcomes (1)

  • Insulin Secretion at 150-180 Minutes.

    The 180 minute value represents the mean of the values obtained at 150, 160, 170, and 180 minutes.

    150 - 180 minutes after GLP-1 infusion

Secondary Outcomes (1)

  • Insulin Secretion at 210-240 Minutes

    210 - 240 minutes after GLP-1 infusion

Study Arms (1)

GLP-1

EXPERIMENTAL

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

Interventions

GLP-1DRUG

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,

GLP-1

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Related Publications (1)

  • Sathananthan A, Man CD, Micheletto F, Zinsmeister AR, Camilleri M, Giesler PD, Laugen JM, Toffolo G, Rizza RA, Cobelli C, Vella A. Common genetic variation in GLP1R and insulin secretion in response to exogenous GLP-1 in nondiabetic subjects: a pilot study. Diabetes Care. 2010 Sep;33(9):2074-6. doi: 10.2337/dc10-0200.

    PMID: 20805279RESULT

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

Glucagon-Like Peptide 1

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Glucagon-Like PeptidesProglucagonGastrointestinal HormonesHormonesHormones, Hormone Substitutes, and Hormone Antagonists

Limitations and Caveats

This is a pilot study with limited power to detect / replicate effects. It will require independent replication of study results.

Results Point of Contact

Title
Adrian Vella
Organization
Mayo Clinic
vella.adrian@mayo.edu
507-284-3754

Study Officials

  • Adrian Vella, MD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Medicine

Study Record Dates

First Submitted

December 22, 2007

First Posted

January 8, 2008

Study Start

November 1, 2007

Primary Completion

September 1, 2010

Study Completion

September 1, 2010

Last Updated

December 19, 2011

Results First Posted

December 6, 2011

Record last verified: 2011-12

Locations

US(1)