Measurement of Outcome of Surgical Treatment in Patients With Acromegaly
| Status: | Recruiting |
|---|---|
| Conditions: | Skin Cancer, Endocrine |
| Therapuetic Areas: | Endocrinology, Oncology |
| Healthy: | No |
| Age Range: | 20 - 75 |
| Updated: | 4/2/2016 |
| Start Date: | September 1999 |
OBJECTIVES: I. Compare growth hormone (GH) levels at baseline and after glucose suppression
measured with both a polyclonal radioimmunoassay and a highly sensitive immunoradiometric
assay (IRMA) in patients with acromegaly and normal volunteers.
II. Measure the levels of IGF-I and its binding protein, IGFBP-3, in these cohorts.
III. Determine any correlation between levels of IGF-I and IGFBP-3 and GH suppressibility as
assessed by sensitive IRMA.
IV. Determine if patients who demonstrate biochemical features of mild GH excess are at risk
for progression to active disease.
measured with both a polyclonal radioimmunoassay and a highly sensitive immunoradiometric
assay (IRMA) in patients with acromegaly and normal volunteers.
II. Measure the levels of IGF-I and its binding protein, IGFBP-3, in these cohorts.
III. Determine any correlation between levels of IGF-I and IGFBP-3 and GH suppressibility as
assessed by sensitive IRMA.
IV. Determine if patients who demonstrate biochemical features of mild GH excess are at risk
for progression to active disease.
PROTOCOL OUTLINE: Blood samples are collected and assessed for growth hormone and IGF-I by
polyclonal radioimmunoassay (RIA) and immunoradiometric assay (IRMA). Growth hormone is
measured at baseline and 60, 90, and 120 minutes after a 100 g glucose drink. Serum glucose
is measured at baseline and at 2 hours post dextrose administration by the glucose
hexokinase method.
Clinical scores are determined for headache, perspiration, fatigue, joint pain, and acne.
Exams and tests may be repeated every 6 months for 2 years.
polyclonal radioimmunoassay (RIA) and immunoradiometric assay (IRMA). Growth hormone is
measured at baseline and 60, 90, and 120 minutes after a 100 g glucose drink. Serum glucose
is measured at baseline and at 2 hours post dextrose administration by the glucose
hexokinase method.
Clinical scores are determined for headache, perspiration, fatigue, joint pain, and acne.
Exams and tests may be repeated every 6 months for 2 years.
PROTOCOL ENTRY CRITERIA:
--Disease Characteristics--
Diagnosis of acromegaly and treated with transsphenoidal surgery
Biochemically and histologically confirmed growth hormone secreting tumor
OR
Healthy volunteers
--Prior/Concurrent Therapy--
Surgery:
- See Disease Characteristics
- Greater than 6 months since prior surgery
Other: At least 1 month since prior bromocriptine or octreotide
--Patient Characteristics--
Performance status: Ambulatory
Hepatic: No active hepatic disease
Renal: No active renal disease
Other:
- No diabetes mellitus
- No glucose intolerance
- Hypopituitarism allowed if on stable doses of replacement therapy
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