Primary outcomeMean· baseline and 6 months
Change in High-sensitivity C-reactive Protein
| Group | Value (mg/liter) | Spread |
|---|---|---|
| AcroGHD Randomized to Growth Hormone | 2.93 | 3.32 |
| AcroGHD Randomized to Placebo | 3.23 | 2.42 |
Trial · Interventional
CompletedNot applicableResults postedRegistry dataEffects of Growth Hormone Administration on Cardiovascular Risk in Cured Acromegalics With Growth Hormone Deficiency
NCTNCT00182091 (opens ClinicalTrials.gov in a new tab)Other id2004p-001078
Overview
- Status
- Completed
- Phase
- Not applicable
- Enrollment
- 75 participants (actual)
- Sponsor
- Massachusetts General Hospital · Other
- Design
- Randomized · Single masking
- Countries
1 country
United States
- Start
- Aug 2004
- Primary completion
- Dec 2009
- Completion
- Dec 2010
- First posted
- 16 Sept 2005 (estimated)
- Last update posted
- 2 Sept 2020
- Conditions
- Acromegaly · Growth Hormone Deficiency · Pituitary Disease
Timeline
1 trial · 1 completed · 1 with posted results
- Completed
- Ongoing
- Not yet recruiting
- Stopped
- Estimated dates (est.)
- Results posted
2004200620082010
- N/A
Effects of Growth Hormone Administration on Cardiovascular Risk in Cured Acromegalics With Growth Hormone Deficiency
NCT00182091Aug 2004 to Dec 2010
Registry summary
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
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).
Interventions
- Recombinant human growth hormoneDrug
- SalineDrug
Arms4
Active comparator
AcroGHD Randomized to Growth Hormone
Subjects with a history of acromegaly who are now growth hormone deficient, randomized to growth hormone. This is an interventional arm.
Placebo comparator
AcroGHD Randomized to Placebo
Subjects with a history of acromegaly who are now growth hormone deficient, randomized to placebo. This is an interventional arm.
No intervention
AcroGHS
No intervention
Active Acromegaly
Primary outcomes1
Outcomes the sponsor listed as primary.
Change in High-sensitivity C-reactive Protein
Time frame · baseline and 6 months
Registry description
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.
Secondary outcomes(3)
Change in Total Fat Mass
Time frame · baseline and 6 months
Registry description
Change in total fat mass 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.
Change in Total Abdominal Adipose Tissue
Time frame · baseline and 6 months
Registry description
Change in total abdominal adipose tissue 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.
Change in Visceral Abdominal Adipose Tissue
Time frame · baseline and 6 months
Registry description
Change in visceral abdominal adipose tissue 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.
Posted results
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
Primary outcome results
Secondary and other outcome results(3)
Secondary outcomeMean· baseline and 6 months
Change in Total Fat Mass
| Group | Value (kilograms) | Spread |
|---|---|---|
| AcroGHD Randomized to Growth Hormone | 29.9 | 9.2 |
| AcroGHD Randomized to Placebo | 32.3 | 12.0 |
Secondary outcomeMean· baseline and 6 months
Change in Total Abdominal Adipose Tissue
| Group | Value (millimeters squared) | Spread |
|---|---|---|
| AcroGHD Randomized to Growth Hormone | 47654 | 12725 |
| AcroGHD Randomized to Placebo | 46949 | 16674 |
Secondary outcomeMean· baseline and 6 months
Change in Visceral Abdominal Adipose Tissue
| Group | Value (millimeters squared) | Spread |
|---|---|---|
| AcroGHD Randomized to Growth Hormone | 14207 | 6730 |
| AcroGHD Randomized to Placebo | 19006 | 9922 |
Adverse events, as posted
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| AcroGHD Randomized to Growth HormoneSubjects with a history of acromegaly who are now growth hormone deficient, randomized to growth hormone. This is an interventional arm. | – | 0 / 15 | 0 / 15 |
| AcroGHD Randomized to PlaceboSubjects with a history of acromegaly who are now growth hormone deficient, randomized to placebo. This is an interventional arm. | – | 0 / 15 | 0 / 15 |
| AcroGHSSubjects with a history of acromegaly who now have normal growth hormone levels. This is not an interventional arm. | – | 0 / 25 | 0 / 25 |
| Active AcromegalySubjects with active acromegaly. This is not an interventional arm. | – | 0 / 20 | 0 / 20 |
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
Studies1
Studies that cite this trial.
More studies
1 study on this page
Indexing hint: Randomized controlled trial · 2010
Growth hormone deficiency after treatment of acromegaly: a randomized, placebo-controlled study of growth hormone replacement.
Miller et al. 2010The Journal of clinical endocrinology and metabolismcited by 44
PMID 20061426PMC2840863DOI 10.1210/jc.2009-1611PUB-20061426
Rights unknown
Other registry references
References listed at the registry that are not in PepBank. They link to PubMed.
- ResultWexler T, Gunnell L, Omer Z, Kuhlthau K, Beauregard C, Graham G, Utz AL, Biller B, Nachtigall L, Loeffler J, Swearingen B, Klibanski A, Miller KK. Growth hormone deficiency is associated with decreased quality of life in patients with prior acromegaly. J Clin Endocrinol Metab. 2009 Jul;94(7):2471-7. doi: 10.1210/jc.2008-2671. Epub 2009 Apr 14. PMID 19366847
- ResultWexler TL, Durst R, McCarty D, Picard MH, Gunnell L, Omer Z, Fazeli P, Miller KK, Klibanski A. Growth hormone status predicts left ventricular mass in patients after cure of acromegaly. Growth Horm IGF Res. 2010 Oct;20(5):333-7. doi: 10.1016/j.ghir.2010.05.003. Epub 2010 Jul 3. PMID 20598930
Eligibility
Who could join, as posted.
- Sex
- All
- Age
- from 18 Years up to 85 Years
- Healthy volunteers
- Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria:
* Age 18-75
* History of acromegaly with biochemical cure documented with a normal oral glucose tolerance test (OGTT) and/or a non-elevated IGF-I without concurrent use of somatostatin analogs, dopamine agonists or GH receptor antagonists. Subjects will have been treated with medication, surgery, radiation, or a combination of these
* At the time of enrollment a minimum of 6 months must have elapsed since surgery.
* No malignancy on colonoscopy performed since the diagnosis of acromegaly
* GHD due to surgical or radiation treatment
* GHD will be defined as a peak plasma GH of less than 5 ng/ml in response to an insulin tolerance test or a GH-releasing hormone (GHRH) plus arginine stimulation test
* GHD will also be diagnosed if IGF-I levels are below 2 standard deviations for the age-sex normal range in a patient with at least two other documented anterior pituitary hormone deficiencies
Exclusion Criteria:
* Untreated thyroid or adrenal insufficiency. Subjects on replacement therapy must be stable for at least 3 months prior to entry into the study
* History of malignancy except for non-melanoma skin cancer
* Hemoglobin \<11.0 gm/dl
* Uncontrolled hypertension
* Hepatic or renal disease (aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \> 3x upper limit of normal (ULN) or creatinine level \>2.5 mg/dl)
* Congestive heart failure (New York Heart Association's classification system Class II-IV congestive heart failure (CHF) will be excluded)
* Unstable cardiovascular disease (coronary artery or cerebrovascular disease) or symptoms within one year prior to entry into the study
* Initiation or discontinuation of gonadal steroid therapy within 3 months of entry
* Diabetes mellitus, impaired fasting glucose, impaired glucose tolerance
* Pregnancy or nursing
* Active carpal tunnel syndrome
* Subjects who have received GH therapy within one year prior to entry into the study
* For female subjects age \>40 a screening mammogram must have been obtained within one year prior to their baseline visit.
* Sensitivity to m-cresol
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