At a glance
ClinicalIndex Comparison Record- ✓Age 18-75 years
- ✓History of acromegaly with biochemical cure (normal OGTT and/or normal IGF-I without concurrent somatostatin analogs, dopamine agonists, or GH receptor antagonists)
- ✓Minimum 6 months elapsed since acromegaly surgery
- ✓No malignancy on colonoscopy since acromegaly diagnosis
- ✕Untreated thyroid or adrenal insufficiency (or unstable if on replacement)
- ✕History of malignancy except non-melanoma skin cancer
- ✕Hemoglobin <11.0 gm/dl
- ✕Uncontrolled hypertension
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Effects of Physiologic Growth Hormone Administration on Cardiovascular Risk in Subjects With Growth Hormone Deficiency Following Cure of Acromegaly
In Brief
A clinical study evaluating Recombinant human growth hormone and Saline for Acromegaly and 2 related conditions. Completed, enrolled 75 participants across 1 site.
Detailed 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).
Study Details
Timeline
Interventions
Starting dose based on age, sex, and estrogen status and ranged from 3-6 mcg/kg/day. GH doses were adjusted based on IGF-1 levels to target the mid-normal range for age.
To maintain study-subject blinding, doses were sham adjusted.