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

Insulin Resistance Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00846872
• Other study ID #: 65-08
• Status: Withdrawn
• Phase: Phase 1/Phase 2
• Start date: July 2008
• Est. completion date: March 2012

Study information

• Verified date: January 2021
• Source: Tulane University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: March 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 45 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Endothelial Dysfunction
• Insulin Resistance

Intervention

Drug:
• GHRP-3 low dose
0.1 µg/kg/hr will be infused subcutaneously in a continuous manner using the Omnipod at the rate of 28 µl/hr
• GHRP-3 high dose
0.5 µg/kg/hr will be infused subcutaneously in a continuous manner using the Omnipod at the rate of 28 µl/hr
• Saline
5% mannitol will be infused subcutaneously in a continuous manner using the Omnipod at the rate of 28 µl/hr

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Tulane University Health Sciences Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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		6 months
Secondary	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.		6 months