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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: Completed NA study of Growth Hormone Deficiency and Acromegaly, sponsored by Massachusetts General Hospital.
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. According to ClinicalTrials.gov, the official US trial registry.
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).
Primary Outcome
Change in high-sensitivity C-reactive protein in the AcroGHD randomized to Growth Hormone and AcroGHD randomized to Placebo arms. Note that the AcroGHS and Active Acromegaly arms were not interventional arms and thus do not have outcome results.
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 |
What the finished NCT00182091 record still lists
NCT00182091 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 75 participants, a relatively small participant target, below the 383-participant average among 16 other Growth Hormone Deficiency trials with a reported enrollment target (80% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
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Where NCT00182091's enrollment target sits among peer trials
75 6th of 16 higher than 11 of 16 other Growth Hormone Deficiency trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Growth Hormone Deficiency trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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