Measurement of Outcome of Surgical Treatment in Patients With Acromegaly

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00005100

Enrollment

165

Registered

2000-04-07

Start date

1999-09-30

Completion date

Unknown

Last updated

2005-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acromegaly

Keywords

acromegaly, endocrine disorders, rare disease

Brief summary

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.

Detailed description

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.

Interventions

None listed

Eligibility

Sex/Gender

ALL

Age

20 Years to 75 Years

Healthy volunteers

Yes

Inclusion criteria

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

Countries

United States

Outcome results