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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

Page last updated: August 23, 2015

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