Dose-response Study of Exendin-9,39 on Glucose Metabolism

NCT ID: NCT01218633

Last Updated: 2013-01-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

11 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-05-31

Study Completion Date

2012-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Saline

Group Type PLACEBO_COMPARATOR

saline infusion

Intervention Type DRUG

saline infused at 30ml/hour

GLP-1-(9,36)-amide

Group Type ACTIVE_COMPARATOR

GLP-1-9,36 infusion

Intervention Type DRUG

infused @ 1.2pmol/kg/min

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

Group Type ACTIVE_COMPARATOR

Exendin-9,39 at low dose

Intervention Type DRUG

infused at 30pmol/kg/min

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

Group Type ACTIVE_COMPARATOR

Exendin-9,39 at high dose

Intervention Type DRUG

infused @ 300pmol/kg/min

Interventions

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saline infusion

saline infused at 30ml/hour

Intervention Type DRUG

GLP-1-9,36 infusion

infused @ 1.2pmol/kg/min

Intervention Type DRUG

Exendin-9,39 at low dose

infused at 30pmol/kg/min

Intervention Type DRUG

Exendin-9,39 at high dose

infused @ 300pmol/kg/min

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

Healthy Not on any medication other than thyroid hormone replacement or OCP No history of diabetes No prior upper GI surgery
Minimum Eligible Age

20 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Adrian Vella

OTHER

Sponsor Role lead

Responsible Party

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Adrian Vella

Professor of Medicine

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Adrian Vella, MD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

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Mayo Clinic

Rochester, Minnesota, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 23545708 (View on PubMed)

Other Identifiers

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10-003435

Identifier Type: -

Identifier Source: org_study_id

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