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

NCT00846872 | Withdrawn Phase 1 DMC

• 1 other identifier: 65-08
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Insulin Resistance; Endothelial Dysfunction

Keywords

GHRP-3; Insulin Resistance; Markers of inflammation; Endothelial Dysfunction; Flow Mediated Dilation; GH/IGF-1 axis; Post menopausal

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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

Study Arms (3)

Low dose GHRP-3

ACTIVE COMPARATOR

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.

Drug: GHRP-3 low dose

High dose GHRP -3

ACTIVE COMPARATOR

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.

Drug: GHRP-3 high dose

Saline Infusion

PLACEBO COMPARATOR

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.

Drug: Saline

Interventions

GHRP-3 low dose DRUG

0.1 µg/kg/hr will be infused subcutaneously in a continuous manner using the Omnipod at the rate of 28 µl/hr

Also known as: Formerly coded as 1485, Fourth generation growth hormone secretagogue

Low dose GHRP-3

GHRP-3 high dose DRUG

0.5 µg/kg/hr will be infused subcutaneously in a continuous manner using the Omnipod at the rate of 28 µl/hr

Also known as: Formerly coded as 1485, Fourth generation growth hormone secretagogue

High dose GHRP -3

Saline DRUG

5% mannitol will be infused subcutaneously in a continuous manner using the Omnipod at the rate of 28 µl/hr

Also known as: 5% mannitol

Saline Infusion

Eligibility Criteria

• Age: 45 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tulane University Health Sciences Center: lead

MeSH Terms

Conditions

Insulin Resistance

Interventions

Sodium Chloride; Mannitol

Condition Hierarchy (Ancestors)

Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds; Sugar Alcohols; Alcohols; Organic Chemicals; Carbohydrates

Study Officials

• Tina K Thethi, MD, MPH

  AdventHealth

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 17, 2009
• First Posted: February 19, 2009
• Study Start: July 1, 2008
• Primary Completion: March 1, 2012
• Study Completion: March 1, 2012
• Last Updated: January 8, 2021

Record last verified: 2021-01