Measurement of Outcome of Surgical Treatment in Patients With Acromegaly
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.
Studieoversikt
Status
Forhold
Detaljert beskrivelse
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.
Studietype
Registrering
Kontakter og plasseringer
Studiesteder
-
-
New York
-
New York, New York, Forente stater, 10032
- Rekruttering
- Columbia University College of Physicians and Surgeons
-
Ta kontakt med:
- Pamela U. Freda
- Telefonnummer: 212-305-3725
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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
Studieplan
Hvordan er studiet utformet?
Samarbeidspartnere og etterforskere
Samarbeidspartnere
Etterforskere
- Studiestol: Pamela U. Freda, Columbia University
Studierekorddatoer
Studer hoveddatoer
Studiestart
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- NCRR-M01RR00645-2525
- CPMC-IRB-7590
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .