Measurement of Outcome of Surgical Treatment in Patients With Acromegaly

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Primary Purpose

Status

Unknown status

Phase

Locations

United States

Study Type

Observational

Intervention

About this trial

This is an observational trial for Acromegaly focused on measuring acromegaly, endocrine disorders, rare disease

Eligibility Criteria

20 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Columbia University College of Physicians and SurgeonsRecruiting

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

NCT ID

NCT00005100

First Posted

April 6, 2000

Last Updated

June 23, 2005

Sponsor

National Center for Research Resources (NCRR)

Collaborators

Columbia University

1. Study Identification

Unique Protocol Identification Number

NCT00005100

Brief Title

Measurement of Outcome of Surgical Treatment in Patients With Acromegaly

Study Type

Observational

2. Study Status

Record Verification Date

December 2003

Overall Recruitment Status

Unknown status

Study Start Date

September 1999 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

National Center for Research Resources (NCRR)

Collaborators

Columbia University

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Acromegaly

Keywords

acromegaly, endocrine disorders, rare disease

7. Study Design

Enrollment

165 (false)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Pamela U. Freda

Organizational Affiliation

Columbia University

Official's Role

Study Chair

Facility Information:

Facility Name

Columbia University College of Physicians and Surgeons

City

New York

State/Province

New York

ZIP/Postal Code

10032

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Pamela U. Freda

Phone

212-305-3725

Acromegaly

About this trial

Eligibility Criteria

Sites / Locations

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

10. Eligibility

12. IPD Sharing Statement

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