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NCT00005100 Clinical Trial

Measurement of Outcome of Surgical Treatment in Patients With Acromegaly

Acromegaly Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT00005100
Other study ID # NCRR-M01RR00645-2525
Secondary ID CPMC-IRB-7590
Status Recruiting
Phase N/A
First received April 6, 2000
Last updated June 23, 2005
Start date September 1999

Study information
Verified date December 2003
Source National Center for Research Resources (NCRR)
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 165
Est. completion date
Est. primary completion date
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 20 Years to 75 Years
Eligibility 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

Study Design

Primary Purpose: Screening

Related Conditions & MeSH terms

Locations
Country Name City State
United States Columbia University College of Physicians and Surgeons New York New York

Sponsors (2)
Lead Sponsor Collaborator
National Center for Research Resources (NCRR) Columbia University

Country where clinical trial is conducted

United States, 

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Completed NCT00500227 - Predictive Factors of Response to Somatostatin Analogues in Acromegalic Patients With Persistent Disease Following Surgery
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Active, not recruiting NCT03252353 - Efficacy and Safety of Octreotide Capsules (MYCAPSSA) in Acromegaly Phase 3
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