AcromegalyNCT00005100
Measurement of Outcome of Surgical Treatment in Patients With Acromegaly
An observational study of Acromegaly, run by National Center for Research Resources (NCRR) at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 20 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Acromegaly
- How many people
- 165 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 1999to not given
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Columbia University College of Physicians and Surgeons
New York, New York, 10032
Pamela U. Freda, 212-305-3725
About this study
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.
Read the 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.
- Conditions
- Acromegaly
- Keywords
- acromegaly, endocrine disorders, rare disease
- Medical subject headings
- Acromegaly, Endocrine System Diseases, Rare Diseases
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2000 (estimated)
- Study startSep 1999
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AcromegalyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Enrolment
- 165 participants
Sponsor and investigators
- Lead sponsor
- National Center for Research Resources (NCRR)
- Sponsor type
- US National Institutes of Health
- Collaborators
- Columbia University
- Investigators
- Pamela U. Freda, Study chair, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00005100
- Sponsor's protocol ID
- NCRR-M01RR00645-2525
- Other IDs
- CPMC-IRB-7590
- Status last verified
- Dec 2003
- First submitted
- 6 Apr 2000
- Last updated
- 24 Jun 2005
- Results posted
- No