The Effect of VTC-G15 (a Pentapeptide Cleavage Product og GLP-1) on Whole Body Glucose Metabolism in Man (LVKGR)

August 7, 2015 updated by: Elahi, Dariush, PhD
To asses the modulating properties of the cleaved pentapeptide product of GLP-1 amide.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

The investigators have previously demonstrated that infusion of the pentapeptide during hyperglycemic clamps in dogs significantly increases the glucose infusion rate necessary to maintain stable hyperglycemia without any significant differences in insulin or glucagon secretion. The present study's aim is to examine whether this also occurs in humans. It may be necessary to examine a dose response curve. Specifically, in twenty healthy volunteers glucose infusion rate during the peptide infusion will be compared to the glucose infusion rate during saline administration during a 4 hour hyperglycemic clamp, in a cross over design(mg/kg/min).

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • BMI 18.5-25;
  • 33-38

Exclusion Criteria:

  • T2D
  • T1D
  • Hypoglycemic agents

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Drug GLP-1 (32-36) Amide
To examine insulinomemtic of the last 5 amino acids of GLP-1 from 60-180 min during a 4 hour hyperglycemic clamp
Drug: Last 5 amino acids of GLP-1
To examine insulinomimetic properties of LVKGR
Other Names:
  • VTC-G15; LVKGR
Placebo Comparator: Placebo
To examine the effect of saline on glucose uptake
Drug: placebo saline

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The effect of VTC-G15 on whole body glucose metabolism in man will be assessed by comparison of amont of glucose infusion during the peptide infusion compared to amount of infusion during placebo infusion (saline) mg/kg/min.
Time Frame: one year
one year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
THe effect of VTC-G15(A pentapeptide cleavage product of GLP-1) on whole body glucose metabolism in man.
Time Frame: one year
changes in insulin or glucagon release.
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Elahi, Dariush, PhD

Collaborators

Massachusetts General Hospital
National Institute on Aging (NIA)
ICON plc

Investigators

  • Principal Investigator: Dariush Elahi, PhD, ICON plc, 8307 Gault Lane, San Antonio TX 78209

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2015

Primary Completion (Anticipated)

March 1, 2016

Study Completion (Anticipated)

March 1, 2016

Study Registration Dates

First Submitted

June 25, 2015

First Submitted That Met QC Criteria

August 7, 2015

First Posted (Estimate)

August 10, 2015

Study Record Updates

Last Update Posted (Estimate)

August 10, 2015

Last Update Submitted That Met QC Criteria

August 7, 2015

Last Verified

August 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VTC-G15

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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