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Differential Effects of rhGH vs. rhIGF-1 on Cardiovascular Risk Factors

Primary Purpose

Growth Hormone Deficiency

Status

Terminated

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Recombinant Human Growth Hormone

Recombinant human IGF-1

About this trial

This is an interventional diagnostic trial for Growth Hormone Deficiency

Eligibility Criteria

25 Years - 65 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

Adult male age 25-65 with documented growth hormone deficiency on stable doses x 3 months (at least) of any hormone replacement therapies and with stable MRIs x 2 years in the setting of a known pituitary mass.

Exclusion Criteria:

Female gender
current GH use or GH use within three months of the study
diabetes
hypoglycemia
liver or kidney disease
use of drugs that could increase GH secretion (i.e. L-dopa)
alcohol or substance abuse
use of investigational drugs within four weeks of our study and use of supraphysiologic doses of steroids within the previous six months.

Sites / Locations

Columbia University, College of Physicians and Surgeons

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Arm Description

Subject taking growth hormone

Subject taking recombinant human IGF-1

Outcomes

Primary Outcome Measures

Cardiovascular serum risk markers including lipids, IL-6, CRP and homocysteine

Secondary Outcome Measures

Changes in visceral adiposity, intrahepatic and intramyocellular lipids

Changes in endothelial cell function

Full Information

NCT ID

NCT00684957

First Posted

May 23, 2008

Last Updated

November 2, 2012

Sponsor

Columbia University

Collaborators

Tercica

1. Study Identification

Unique Protocol Identification Number

NCT00684957

Brief Title

Differential Effects of rhGH vs. rhIGF-1 on Cardiovascular Risk Factors

Official Title

Differential Effects of rhGH vs. rhIGF-1 on Cardiovascular Risk Factors in Adult Patients With Growth Hormone Deficiency

Study Type

Interventional

2. Study Status

Record Verification Date

November 2012

Overall Recruitment Status

Terminated

Why Stopped

Poor enrollment

Study Start Date

January 2008 (undefined)

Primary Completion Date

October 2012 (Actual)

Study Completion Date

October 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Columbia University

Collaborators

Tercica

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

The purpose of this study is to see if giving growth hormone or insulin-like growth factor-1 (IGF-1) to subjects with growth hormone deficiency effects cardiovascular risk factors differently.

Detailed Description

Insulin-like growth factor-1 (IGF-1) in some circumstances acts as the mediator of the metabolic effects of growth hormone. However, there is some evidence to suggest that GH and IGF-1 act differently in some metabolic pathways. We will study the differences between GH and IGF-1 when provided as therapy for growth hormone deficiency in adults. Specifically we will be assessing if either medication impacts cardiovascular risk factors and if so do they impact risk factors differently. Ten adult males ages 18-65 who are growth hormone deficient on stable medications and with stable MRI findings (in the event of a known pituitary mass) will be recruited for the study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Growth Hormone Deficiency

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

5 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Active Comparator

Arm Description

Subject taking growth hormone

Arm Title

Arm Type

Active Comparator

Arm Description

Subject taking recombinant human IGF-1

Intervention Type

Drug

Intervention Name(s)

Recombinant Human Growth Hormone

Intervention Description

300 mcg sc qd (which may be increased to 400 mcg sc qd after 4 weeks)

Intervention Type

Drug

Intervention Name(s)

Recombinant human IGF-1

Intervention Description

30 µg/kg for first 4 weeks (may be increased thereafter based on IGF-1 levels)

Primary Outcome Measure Information:

Title

Cardiovascular serum risk markers including lipids, IL-6, CRP and homocysteine

Time Frame

2 months

Secondary Outcome Measure Information:

Title

Changes in visceral adiposity, intrahepatic and intramyocellular lipids

Time Frame

2 months

Title

Changes in endothelial cell function

Time Frame

2 months

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

25 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Adult male age 25-65 with documented growth hormone deficiency on stable doses x 3 months (at least) of any hormone replacement therapies and with stable MRIs x 2 years in the setting of a known pituitary mass. Exclusion Criteria: Female gender current GH use or GH use within three months of the study diabetes hypoglycemia liver or kidney disease use of drugs that could increase GH secretion (i.e. L-dopa) alcohol or substance abuse use of investigational drugs within four weeks of our study and use of supraphysiologic doses of steroids within the previous six months.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Pamela U. Freda, M.D.

Organizational Affiliation

Columbia University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Columbia University, College of Physicians and Surgeons

City

New York

State/Province

New York

ZIP/Postal Code

10032

Country

United States

12. IPD Sharing Statement

Learn more about this trial

Differential Effects of rhGH vs. rhIGF-1 on Cardiovascular Risk Factors

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