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Trial · Interventional

TerminatedPhase 1/2Results postedRegistry data

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

NCTNCT00684957 (opens ClinicalTrials.gov in a new tab)Other idAAAC2883Other idTercica-001
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Terminated
Phase
Phase 1/2
Enrollment
5 participants (actual)
Sponsor
Columbia University · Other
Design
Randomized · Open label (no masking)
Countries
1 country

United States

Start
Jan 2008
Primary completion
Oct 2012
Completion
Oct 2012
First posted
28 May 2008 (estimated)
Last update posted
17 Jul 2024
Conditions
Growth Hormone Deficiency

Timeline

1 trial · 1 stopped early · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
200820092010201120122013
  1. Ph 1/2

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

    NCT00684957

    Jan 2008 to Oct 2012

    Terminated

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • Recombinant Human Growth HormoneDrug
  • Recombinant Human IGF-1Drug

Arms2

  • Active comparator

    Recombinant Human Growth Hormone first

    Subjects will take rhGH for eight weeks followed by a two month wash out period and then will cross over to rhIGF1 for eight weeks.

  • Active comparator

    Recombinant Human IGF-1

    Subjects will take rhIGF1 for eight weeks followed by a two month wash out period and then will cross over to rhGH for eight weeks.

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Cardiovascular Serum Risk Markers Including Lipids, IL-6, CRP and Homocysteine

    Time frame · 2 months

Secondary outcomes(2)

  1. Changes in Visceral Adiposity, Intrahepatic and Intramyocellular Lipids

    Time frame · 2 months

  2. Changes in Endothelial Cell Function

    Time frame · 2 months

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcome· 2 months

Cardiovascular Serum Risk Markers Including Lipids, IL-6, CRP and Homocysteine

GroupValue
Study Subjectsnot posted
Secondary and other outcome results(2)
Secondary outcome· 2 months

Changes in Visceral Adiposity, Intrahepatic and Intramyocellular Lipids

GroupValue
Study Subjectsnot posted
Secondary outcome· 2 months

Changes in Endothelial Cell Function

GroupValue
Study Subjectsnot posted

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
Recombinant Human Growth Hormone First, Then Recombinant Human IGF-1Subjects will take Recombinant Human Growth Hormone (rhGH) for eight weeks followed by a two month wash out period and then will cross over to Recombinant Human IGF-1 (rhIGF1) for eight weeks. rhGH dose: 300 mcg sc qd (which may be increased to 400 mcg sc qd after 4 weeks) rhIGF1 dose: 30 µg/kg for first 4 weeks (may be increased thereafter based on IGF-1 levels)0 / 20 / 20 / 2
Recombinant Human IGF-1 First, Then Recombinant Human Growth HormoneSubjects will take Recombinant Human IGF-1 (rhIGF1) for eight weeks followed by a two month wash out period and then will cross over to Recombinant Human Growth Hormone (rhGH) for eight weeks. rhGH dose: 300 mcg sc qd (which may be increased to 400 mcg sc qd after 4 weeks) rhIGF1 dose: 30 µg/kg for first 4 weeks (may be increased thereafter based on IGF-1 levels)0 / 30 / 30 / 3

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
Male
Age
from 25 Years up to 65 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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.

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