search
Back to results

Effect of Continuous GHRP-3 Infusion at on GH-IGF-I System, Blood Pressure, Glucose, and Insulin Resistance

Primary Purpose

Insulin Resistance, Endothelial Dysfunction

Status
Withdrawn
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
GHRP-3 low dose
GHRP-3 high dose
Saline
Sponsored by
Tulane University Health Sciences Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Insulin Resistance focused on measuring GHRP-3, Insulin Resistance, Markers of inflammation, Endothelial Dysfunction, Flow Mediated Dilation, GH/IGF-1 axis, Post menopausal

Eligibility Criteria

45 Years - 85 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  1. Men and post-menopausal women 50-70 years.
  2. Elevated fasting plasma glucose ranging <125 mg/dL
  3. Waist circumference >35 inches in women and >40 inches in men

Exclusion Criteria:

  1. Patients taking medications that may alter carbohydrate metabolism and/or insulin resistance.
  2. Female patients with a positive pregnancy test.
  3. Previous history of hypersensitivity to GHRP.
  4. Patients with overt liver disease, renal disease and/or congestive heart failure.
  5. Patients with anticipated change in medication regimen during the study period.
  6. Current use or history of use of hormone replacement therapy in the last six months.
  7. Current use or history of use of Ace Inhibitors or Angiotensin receptor blockers in the last six months.
  8. Hemoglobin of < 11.6 g/dL for women and < 12.9 g/dL for men.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Active Comparator

    Active Comparator

    Placebo Comparator

    Arm Label

    Low dose GHRP-3

    High dose GHRP -3

    Saline Infusion

    Arm Description

    Subjects will receive the infusion for 14 ± 2 days. On day 1 of the test period, patients will report to the CTRC in a fasting state stay there for 3 - 4 hrs after the initiation of the infusion. Blood will be drawn in a fasting state and urine sample will be collected prior to insertion of the OmniPod and the CGMS. On day 7 +/- 2 days and on day 12 +/- 2 days, patients will report to the CTRC for blood draw and CGMS insertion. On day 14 +/- 2 days, patients will again report to CTRC for 24 hour admit. They will undergo urine sample collection, periodic blood draws and BP monitoring. After the 24 hour period, the CGMS will be disconnected and the patient will undergo FMD after which the test period will be terminated. There will be a washout period of 2 weeks between each test period.

    Subjects will receive the infusion for 14 ± 2 days. On day 1 of the test period, patients will report to the CTRC in a fasting state stay there for 3 - 4 hrs after the initiation of the infusion. Blood will be drawn in a fasting state and urine sample will be collected prior to insertion of the OmniPod and the CGMS. On day 7 +/- 2 days and on day 12 +/- 2 days, patients will report to the CTRC for blood draw and CGMS insertion. On day 14 +/- 2 days, patients will again report to CTRC for 24 hour admit. They will undergo urine sample collection, periodic blood draws and BP monitoring. After the 24 hour period, the CGMS will be disconnected and the patient will undergo FMD after which the test period will be terminated. There will be a washout period of 2 weeks between each test period.

    Subjects will receive Placebo for 14 ± 2 days. On day 1 of the test period, patients will report to the CTRC in a fasting state stay there for 3 - 4 hrs after the initiation of the infusion. Blood will be drawn in a fasting state and urine sample will be collected prior to insertion of the OmniPod and the CGMS. On day 7 +/- 2 days and on day 12 +/- 2 days, patients will report to the CTRC for blood draw and CGMS insertion. On day 14 +/- 2 days, patients will again report to CTRC for 24 hour admit. They will undergo urine sample collection, periodic blood draws and BP monitoring. After the 24 hour period, the CGMS will be disconnected and the patient will undergo FMD after which the test period will be terminated. There will be a washout period of 2 weeks between each test period.

    Outcomes

    Primary Outcome Measures

    Determine the relative effects of 0.1µg/kg/h and 0.5µg/kg/h GHRP-3 as compared to placebo in inducing physiological secretion of the GH-IGF-I system after continuous sc delivery in healthy older men and women with insulin resistance

    Secondary Outcome Measures

    Determine the relative interrelated effects of 0.1 and 0.5µg/kg/h GHRP-3 infusion and placebo on various hormonal and non hormonal aspects of insulin resistance.

    Full Information

    First Posted
    February 17, 2009
    Last Updated
    January 6, 2021
    Sponsor
    Tulane University Health Sciences Center
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT00846872
    Brief Title
    Effect of Continuous GHRP-3 Infusion at on GH-IGF-I System, Blood Pressure, Glucose, and Insulin Resistance
    Official Title
    Effect of Continuous Subcutaneous GHRP-3 Infusion at 2 Dose Levels on the Physiological Secretion of the GH-IGF-I System, Blood Pressure, Glucose, Inflammatory Markers and Endothelial Function in Subjects With Insulin Resistance
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2021
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    Inadequate subject recruitment
    Study Start Date
    July 2008 (undefined)
    Primary Completion Date
    March 2012 (Actual)
    Study Completion Date
    March 2012 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Tulane University Health Sciences Center

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    The hypothesis is that GHRP-3 will exert beneficial effects on endothelial function and insulin resistance in older men and women via hormonal (GH, IGF-I, IGFBP-3,-1, insulin) and non-hormonal actions (anti-inflammatory).
    Detailed Description
    At the lower dose of 0.1 µg/kg/h, GHRP-3 presumably will improve endothelial dysfunction, enhance insulin action and lower blood pressure via the anti-inflammatory effects of GHRP-3 while at the higher dose of 0.5 µg/kg/h GHRP-3 these anti-inflammatory effects will be further augmented by the hormonal action of increasing serum IGF-I and its primary serum binding protein insulin like growth hormone binding protein - 3 (IGFBP-3 as well as -1). Also, the more detailed inter-relationships between the actions of GHRP-3, GH and IGF-I on serum glucose, blood pressure, and lipid levels over 24h periods will be determined at the end of the 14 day placebo and two GHRP-3 infusion periods. The GHRP-3 will be administered in escalating doses. The Specific Aims of this study are as follows: To determine the relative effects of 0.1µg/kg/h and 0.5µg/kg/h GHRP-3 as compared to placebo infusion in inducing physiological secretion of the GH-IGF-I system after continuous sc delivery for 14 days in healthy older men and women with insulin resistance. To determine the relative interrelated effects of 0.1 and 0.5µg/kg/h GHRP-3 infusion and placebo on various hormonal and non hormonal aspects of insulin resistance such as blood pressure (BP), plasma glucose and FFA as well as GH, IGF-I, IGFBP-1, -3, insulin and endothelin-1 levels. To determine the relative effects of placebo and the above 2 doses of GHRP-3 infusion on flow mediated dilation (FMD) and nitroglycerin-dependent dilation

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Insulin Resistance, Endothelial Dysfunction
    Keywords
    GHRP-3, Insulin Resistance, Markers of inflammation, Endothelial Dysfunction, Flow Mediated Dilation, GH/IGF-1 axis, Post menopausal

    7. Study Design

    Primary Purpose
    Other
    Study Phase
    Phase 1, Phase 2
    Interventional Study Model
    Crossover Assignment
    Masking
    Participant
    Allocation
    Non-Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Low dose GHRP-3
    Arm Type
    Active Comparator
    Arm Description
    Subjects will receive the infusion for 14 ± 2 days. On day 1 of the test period, patients will report to the CTRC in a fasting state stay there for 3 - 4 hrs after the initiation of the infusion. Blood will be drawn in a fasting state and urine sample will be collected prior to insertion of the OmniPod and the CGMS. On day 7 +/- 2 days and on day 12 +/- 2 days, patients will report to the CTRC for blood draw and CGMS insertion. On day 14 +/- 2 days, patients will again report to CTRC for 24 hour admit. They will undergo urine sample collection, periodic blood draws and BP monitoring. After the 24 hour period, the CGMS will be disconnected and the patient will undergo FMD after which the test period will be terminated. There will be a washout period of 2 weeks between each test period.
    Arm Title
    High dose GHRP -3
    Arm Type
    Active Comparator
    Arm Description
    Subjects will receive the infusion for 14 ± 2 days. On day 1 of the test period, patients will report to the CTRC in a fasting state stay there for 3 - 4 hrs after the initiation of the infusion. Blood will be drawn in a fasting state and urine sample will be collected prior to insertion of the OmniPod and the CGMS. On day 7 +/- 2 days and on day 12 +/- 2 days, patients will report to the CTRC for blood draw and CGMS insertion. On day 14 +/- 2 days, patients will again report to CTRC for 24 hour admit. They will undergo urine sample collection, periodic blood draws and BP monitoring. After the 24 hour period, the CGMS will be disconnected and the patient will undergo FMD after which the test period will be terminated. There will be a washout period of 2 weeks between each test period.
    Arm Title
    Saline Infusion
    Arm Type
    Placebo Comparator
    Arm Description
    Subjects will receive Placebo for 14 ± 2 days. On day 1 of the test period, patients will report to the CTRC in a fasting state stay there for 3 - 4 hrs after the initiation of the infusion. Blood will be drawn in a fasting state and urine sample will be collected prior to insertion of the OmniPod and the CGMS. On day 7 +/- 2 days and on day 12 +/- 2 days, patients will report to the CTRC for blood draw and CGMS insertion. On day 14 +/- 2 days, patients will again report to CTRC for 24 hour admit. They will undergo urine sample collection, periodic blood draws and BP monitoring. After the 24 hour period, the CGMS will be disconnected and the patient will undergo FMD after which the test period will be terminated. There will be a washout period of 2 weeks between each test period.
    Intervention Type
    Drug
    Intervention Name(s)
    GHRP-3 low dose
    Other Intervention Name(s)
    Formerly coded as 1485, Fourth generation growth hormone secretagogue
    Intervention Description
    0.1 µg/kg/hr will be infused subcutaneously in a continuous manner using the Omnipod at the rate of 28 µl/hr
    Intervention Type
    Drug
    Intervention Name(s)
    GHRP-3 high dose
    Other Intervention Name(s)
    Formerly coded as 1485, Fourth generation growth hormone secretagogue
    Intervention Description
    0.5 µg/kg/hr will be infused subcutaneously in a continuous manner using the Omnipod at the rate of 28 µl/hr
    Intervention Type
    Drug
    Intervention Name(s)
    Saline
    Other Intervention Name(s)
    5% mannitol
    Intervention Description
    5% mannitol will be infused subcutaneously in a continuous manner using the Omnipod at the rate of 28 µl/hr
    Primary Outcome Measure Information:
    Title
    Determine the relative effects of 0.1µg/kg/h and 0.5µg/kg/h GHRP-3 as compared to placebo in inducing physiological secretion of the GH-IGF-I system after continuous sc delivery in healthy older men and women with insulin resistance
    Time Frame
    6 months
    Secondary Outcome Measure Information:
    Title
    Determine the relative interrelated effects of 0.1 and 0.5µg/kg/h GHRP-3 infusion and placebo on various hormonal and non hormonal aspects of insulin resistance.
    Time Frame
    6 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    45 Years
    Maximum Age & Unit of Time
    85 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Men and post-menopausal women 50-70 years. Elevated fasting plasma glucose ranging <125 mg/dL Waist circumference >35 inches in women and >40 inches in men Exclusion Criteria: Patients taking medications that may alter carbohydrate metabolism and/or insulin resistance. Female patients with a positive pregnancy test. Previous history of hypersensitivity to GHRP. Patients with overt liver disease, renal disease and/or congestive heart failure. Patients with anticipated change in medication regimen during the study period. Current use or history of use of hormone replacement therapy in the last six months. Current use or history of use of Ace Inhibitors or Angiotensin receptor blockers in the last six months. Hemoglobin of < 11.6 g/dL for women and < 12.9 g/dL for men.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Tina K Thethi, MD, MPH
    Organizational Affiliation
    AdventHealth
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Effect of Continuous GHRP-3 Infusion at on GH-IGF-I System, Blood Pressure, Glucose, and Insulin Resistance

    We'll reach out to this number within 24 hrs