NCT01218633

Brief Summary

Multiple studies have examined the effect of endogenous GLP-1 secretions by using a competitive antagonist of GLP-1 - Exendin-9,39 - infused at rates of 300pmol/kg/min. However, the presence of an effect does not necessarily imply that this effect is due to the blockade of the endogenous GLP-1 actions at the receptor. It is possible that the supraphysiologic concentrations of Exendin may have effects of its own. To examine the effect of Exendin on glucose metabolism the investigators propose a dose-response study to determine whether the compound has effects in a dose-dependent fashion.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
11

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started May 2011

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

First Submitted

Initial submission to the registry

October 8, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 11, 2010

Completed
7 months until next milestone

Study Start

First participant enrolled

May 1, 2011

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2012

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

January 23, 2013

Status Verified

January 1, 2013

Enrollment Period

1.2 years

First QC Date

October 8, 2010

Last Update Submit

January 18, 2013

Conditions

Pancreatic Effects of 9,39-Exendin and 9,36-GLP-1

Outcome Measures

Primary Outcomes (1)

  • Insulin Secretion

    over 360 minutes of study

Secondary Outcomes (1)

  • glucagon secretion

    over 360 minutes of study

Study Arms (4)

Saline

PLACEBO COMPARATOR
Drug: saline infusion

GLP-1-(9,36)-amide

ACTIVE COMPARATOR
Drug: GLP-1-9,36 infusion

Exendin-9,39 @30pmol/kg/min

ACTIVE COMPARATOR
Drug: Exendin-9,39 at low dose

Exendin-9,39 @300pmol/kg/min

ACTIVE COMPARATOR
Drug: Exendin-9,39 at high dose

Interventions

saline infusionDRUG

saline infused at 30ml/hour

Saline
GLP-1-9,36 infusionDRUG

infused @ 1.2pmol/kg/min

GLP-1-(9,36)-amide
Exendin-9,39 at low doseDRUG

infused at 30pmol/kg/min

Exendin-9,39 @30pmol/kg/min
Exendin-9,39 at high doseDRUG

infused @ 300pmol/kg/min

Exendin-9,39 @300pmol/kg/min

Eligibility Criteria

Age20 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Healthy Not on any medication other than thyroid hormone replacement or OCP No history of diabetes No prior upper GI surgery

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Related Publications (1)

  • Sathananthan M, Farrugia LP, Miles JM, Piccinini F, Dalla Man C, Zinsmeister AR, Cobelli C, Rizza RA, Vella A. Direct effects of exendin-(9,39) and GLP-1-(9,36)amide on insulin action, beta-cell function, and glucose metabolism in nondiabetic subjects. Diabetes. 2013 Aug;62(8):2752-6. doi: 10.2337/db13-0140. Epub 2013 Apr 1.

    PMID: 23545708DERIVED

Study Officials

  • Adrian Vella, MD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor of Medicine

Study Record Dates

First Submitted

October 8, 2010

First Posted

October 11, 2010

Study Start

May 1, 2011

Primary Completion

July 1, 2012

Study Completion

December 1, 2012

Last Updated

January 23, 2013

Record last verified: 2013-01

Locations

US(1)