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NCT00517062 · ClinicalTrials.gov registry record · Early Phase 1

Low Dose Growth Hormone (GH) on Insulin Sensitivity and Cortisol Production Rates

A Early Phase 1 study of Growth Hormone Deficiency, sponsored by Oregon Health and Science University.

Completed
Registry status
Early Phase 1
Development phase
16
Enrollment target
1
Study location

NCT00517062 is a Early Phase 1 study of Growth Hormone Deficiency that has completed, run by Oregon Health and Science University. The registered enrollment target is 16 participants, below the 386-participant average among 16 other Growth Hormone Deficiency trials with a reported enrollment target (96% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT00517062, a Early Phase 1 study of Growth Hormone Deficiency, has completed, sponsored by Oregon Health and Science University.

COMPLETED
Registry status
Early Phase 1
Development phase
16 participants
Enrollment target
1
Study location

Study Summary

Study hypothesis: Growth hormone (GH), through its generation of free 'bioavailable' insulin-like growth factor (IGF)-I, can improve insulin sensitivity in adults with GH deficiency. Study aims: The purpose of this study is to determine the mechanism of how low dose GH treatment affects the body's sensitivity to insulin actions and whether this low GH dose can affect the body's handling of steroid hormone levels (cortisol clearance) in adults with GH deficiency. Study design: Men and women with confirmed GH deficiency, but not recently been on GH treatment will be invited to participate in this study. The subjects will be assessed at the initial visit to ascertain their suitability before further participating in the study. If suitable, an equal number of men and women will be randomized to receive either low dose GH or placebo injection for 3 months. Before, during and after treatment, the subjects will be assessed at regularly with blood tests, scans and fat biopsies. At the first and final visit, testing will include scans to measure the amount of whole body fat and fat in the stomach area, muscle, and liver; blood tests to measure levels of cortisol, and fat tissue (taken from a biopsy) analysis to measure the density of IGF-I in the muscle; whereas blood tests to examine insulin sensitivity will also be collected. This study will use Genotropin and Genotropin pen devices, and the the data will be analyzed using a computer statistical program where the identity of the subjects will be coded to maintain confidentiality.

Conditions Studied

Interventions

  • DRUG Placebo
  • DRUG Growth hormone (Genotropin)

Study Locations (1)

Oregon

  • Oregon Health and Science University - Portland

Trial Details

FieldValue
Enrollment Target 16 participants
Start Date 2006-01
Est. Completion 2012-01
Phase Early Phase 1

What the Registry Record Tells You About NCT00517062

The ClinicalTrials.gov registry entry for NCT00517062 describes a study currently listed as completed, categorized as Early Phase 1. The registered enrollment target is 16 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 386-participant average among 16 other Growth Hormone Deficiency trials with a reported enrollment target (96% lower). The listed sponsor is Oregon Health and Science University, which has 546 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Growth Hormone Deficiency appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.

NCT00517062 reports 1 study location spanning 1 distinct geographic area - top geographies include Oregon.

Frequently Asked Questions

What is clinical trial NCT00517062 about?

NCT00517062 is a clinical study titled "Low Dose Growth Hormone (GH) on Insulin Sensitivity and Cortisol Production Rates". Study hypothesis: Growth hormone (GH), through its generation of free 'bioavailable' insulin-like growth factor (IGF)-I, can improve insulin sensitivity in adults with GH deficiency. Study aims: The purpose of this study is to determine the mechanism of how low dose GH treatment affects the body'...

What is the current status of trial NCT00517062?

This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 16 participants. The study started on 2006-01. Estimated completion is 2012-01.

What conditions does trial NCT00517062 study?

This clinical trial studies the following conditions: Growth Hormone Deficiency.

What interventions are being tested in trial NCT00517062?

The interventions under investigation include: Placebo (DRUG), Growth hormone (Genotropin) (DRUG).

Who is sponsoring clinical trial NCT00517062?

This trial is sponsored by Oregon Health and Science University, which has 546 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00517062 being conducted?

This trial has 1 study location across Oregon. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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