Ignite Creation Date:
2024-05-05 @ 10:22 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00005100
Status:
UNKNOWN
Last Update Posted:
2005-06-24
First Post:
2000-04-06
Brief Title:
Measurement of Outcome of Surgical Treatment in Patients With Acromegaly
Sponsor:
National Center for Research Resources NCRR
Organization:
National Center for Research Resources NCRR
Study Overview
Official Title:
None
Status:
UNKNOWN
Status Verified Date:
2003-12
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Clinical scores are determined for headache perspiration fatigue joint pain and acne
Exams and tests may be repeated every 6 months for 2 years
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CPMC-IRB-7590 | None | None | None |