Back to resultsThe Effect of VTC-G15 (a Pentapeptide Cleavage Product og GLP-1) on Whole Body Glucose Metabolism in Man (LVKGR)
Primary Purpose
Insulin Resistance
Status
Unknown status
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Last 5 amino acids of GLP-1
placebo saline
Sponsored by
About this trial
This is an interventional supportive care trial for Insulin Resistance
Eligibility Criteria
Inclusion Criteria:
- BMI 18.5-25;
- 33-38
Exclusion Criteria:
- T2D
- T1D
- Hypoglycemic agents
Sites / Locations
- ICON PLCRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Drug GLP-1 (32-36) Amide
Placebo
Arm Description
To examine insulinomemtic of the last 5 amino acids of GLP-1 from 60-180 min during a 4 hour hyperglycemic clamp
To examine the effect of saline on glucose uptake
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
THe effect of VTC-G15(A pentapeptide cleavage product of GLP-1) on whole body glucose metabolism in man.
changes in insulin or glucagon release.
Full Information
NCT ID
NCT02518932
First Posted
June 25, 2015
Last Updated
August 7, 2015
Sponsor
Elahi, Dariush, PhD
Collaborators
ICON plc, Massachusetts General Hospital, National Institute on Aging (NIA)
1. Study Identification
Unique Protocol Identification Number
NCT02518932
Brief Title
The Effect of VTC-G15 (a Pentapeptide Cleavage Product og GLP-1) on Whole Body Glucose Metabolism in Man
Acronym
LVKGR
Official Title
The Effect of VTC-G15 (a Pentapeptide Cleavage Product og GLP-1) on Whole Body Glucose Metabolism in Man
Study Type
Interventional
2. Study Status
Record Verification Date
August 2015
Overall Recruitment Status
Unknown status
Study Start Date
March 2015 (undefined)
Primary Completion Date
March 2016 (Anticipated)
Study Completion Date
March 2016 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Elahi, Dariush, PhD
Collaborators
ICON plc, Massachusetts General Hospital, National Institute on Aging (NIA)
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
To asses the modulating properties of the cleaved pentapeptide product of GLP-1 amide.
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Insulin Resistance
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Drug GLP-1 (32-36) Amide
Arm Type
Experimental
Arm Description
To examine insulinomemtic of the last 5 amino acids of GLP-1 from 60-180 min during a 4 hour hyperglycemic clamp
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
To examine the effect of saline on glucose uptake
Intervention Type
Drug
Intervention Name(s)
Last 5 amino acids of GLP-1
Other Intervention Name(s)
VTC-G15; LVKGR
Intervention Description
To examine insulinomimetic properties of LVKGR
Intervention Type
Drug
Intervention Name(s)
placebo saline
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
THe effect of VTC-G15(A pentapeptide cleavage product of GLP-1) on whole body glucose metabolism in man.
Description
changes in insulin or glucagon release.
Time Frame
one year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
BMI 18.5-25;
33-38
Exclusion Criteria:
T2D
T1D
Hypoglycemic agents
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dariush E;ahi, PhD
Phone
210-283-4520
Email
dariush.elahi@iconplc.com
First Name & Middle Initial & Last Name or Official Title & Degree
Dennis A Ruff, MD
Phone
210-283-4572
Email
dennis.ruff@iconplc.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dariush Elahi, PhD
Organizational Affiliation
ICON plc, 8307 Gault Lane, San Antonio TX 78209
Official's Role
Principal Investigator
Facility Information:
Facility Name
ICON PLC
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78209
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rita Flusche
Phone
210-283-4123
Email
Rita.flusche@iconplc.com
12. IPD Sharing Statement
Learn more about this trial
The Effect of VTC-G15 (a Pentapeptide Cleavage Product og GLP-1) on Whole Body Glucose Metabolism in Man
We'll reach out to this number within 24 hrs