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NCT00182091 · ClinicalTrials.gov registry record · NA
Effects of Growth Hormone Administration on Cardiovascular Risk in Cured Acromegalics With Growth Hormone Deficiency
A NA study of Growth Hormone Deficiency and Acromegaly, sponsored by Massachusetts General Hospital.
- Completed
- Registry status
- NA
- Development phase
- 75
- Enrollment target
- 1
- Study location
NCT00182091 is a NA study of Growth Hormone Deficiency and Acromegaly that has completed, run by Massachusetts General Hospital. The registered enrollment target is 75 participants, below the 383-participant average among 16 other Growth Hormone Deficiency trials with a reported enrollment target (80% lower). The trial reports 1 study location across 1 state.
The verdict
NCT00182091, a NA study of Growth Hormone Deficiency and Acromegaly, has completed, sponsored by Massachusetts General Hospital.
- COMPLETED
- Registry status
- NA
- Development phase
- 75 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of the study is to evaluate the effects of growth hormone (GH) replacement in men and women with a history of acromegaly and who are now growth hormone deficient. We will compare them to persons with a history of acromegaly who have normal GH levels. Acromegaly results when an area in the brain, called the pituitary, produces too much growth hormone. When an individual is cured of acromegaly, the growth hormone levels may be normal or low (that is GH deficiency). Growth hormone deficiency means the body no longer produces as much growth hormone because the pituitary/hypothalamic region was damaged by a tumor or by treatment received. We will study the effects of growth hormone replacement on the health of the heart and blood vessels of GH deficient persons by looking to see if this therapy: 1. has effects on cardiovascular risk markers (special blood tests which indicate how healthy your heart and arteries are) 2. affects the stiffness of the arteries 3. affects your heart rate and the capacity of your heart to respond to changes in body position 4. has different effects depending on whether you are taking estrogen / testosterone. We will assess these measures of health on one occasion in persons with cured acromegaly and normal GH levels and in persons with cured acromegaly who have GH deficiency and a contraindication to receiving GH. GH deficient individuals with no contraindication to receiving GH, will participate in the study for 12 months. Individuals with normal GH levels, or who are GH deficient and have a contraindication to receiving GH, will be asked to return for one more visit (without any interventions).
Conditions Studied
Interventions
- DRUG Saline
- DRUG Recombinant human growth hormone
Study Locations (1)
Massachusetts
- Massachusetts General Hospital - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 75 participants |
| Start Date | 2004-08 |
| Est. Completion | 2010-12 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00182091
The ClinicalTrials.gov registry entry for NCT00182091 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 75 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 383-participant average among 16 other Growth Hormone Deficiency trials with a reported enrollment target (80% lower). The listed sponsor is Massachusetts General Hospital, which has 2,032 total studies on file at ClinicalTrials.gov.
The record links to 3 conditions, with Growth Hormone Deficiency appearing as the primary indexed condition, and to 2 interventions - of which Saline is the first listed.
NCT00182091 reports 1 study location spanning 1 distinct geographic area - top geographies include Massachusetts.
Frequently Asked Questions
What is clinical trial NCT00182091 about?
NCT00182091 is a clinical study titled "Effects of Growth Hormone Administration on Cardiovascular Risk in Cured Acromegalics With Growth Hormone Deficiency". The purpose of the study is to evaluate the effects of growth hormone (GH) replacement in men and women with a history of acromegaly and who are now growth hormone deficient. We will compare them to persons with a history of acromegaly who have normal GH levels. Acromegaly results when an area in t...
What is the current status of trial NCT00182091?
This trial is currently completed. It is a NA study. The enrollment target is 75 participants. The study started on 2004-08. Estimated completion is 2010-12.
What conditions does trial NCT00182091 study?
This clinical trial studies the following conditions: Growth Hormone Deficiency, Acromegaly, Pituitary Disease.
What interventions are being tested in trial NCT00182091?
The interventions under investigation include: Saline (DRUG), Recombinant human growth hormone (DRUG).
Who is sponsoring clinical trial NCT00182091?
This trial is sponsored by Massachusetts General Hospital, which has 2,032 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00182091 being conducted?
This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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