Effect of Continuous GHRP-3 Infusion at on GH-IGF-I System, Blood Pressure, Glucose, and Insulin Resistance
Information source: Tulane University Health Sciences Center
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Insulin Resistance; Endothelial Dysfunction
Intervention: GHRP-3 (Drug); GHRP-3 (Drug); Saline (Drug)
Phase: Phase 1/Phase 2
Status: Terminated
Sponsored by: Tulane University Health Sciences Center Official(s) and/or principal investigator(s): Tina K Thethi, MD, MPH, Principal Investigator, Affiliation: Tulane Universtiy Health Sciences Center Jennifer J Kalarickal, MD, Principal Investigator, Affiliation: Tulane University Health Sciences Center Vivian Fonseca, MD, FRCP, Principal Investigator, Affiliation: Tulane University Health Sciences Center Cyril Bowers, MD, Principal Investigator, Affiliation: Tulane University Health Sciences Center
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).
Clinical Details
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 design: Allocation: Non-Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject)
Primary outcome: 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: 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.
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:
1. 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.
2. 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.
3. 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
Eligibility
Minimum age: 45 Years.
Maximum age: 85 Years.
Gender(s): Both.
Criteria:
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.
Locations and Contacts
Clinical and Translational Research center Tulane Hospital, New Orleans, Louisiana 70112, United States
Clinical and Translational Research Center, University Hospital, New Orleans, Louisiana 70112, United States
Additional Information
Starting date: July 2008
Last updated: May 5, 2014
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