Suspended

Assessment of Surgical Treatment Outcome in Acromegaly Patients

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What is being collected

Data Collection

Who is being recruted

Bone Diseases+12

+ Bone Diseases, Endocrine

+ Brain Diseases

From 20 to 75 Years
See all eligibility criteria
How is the trial designed

Observational
Study Start: September 1999
See protocol details

Summary

Principal SponsorNational Center for Research Resources (NCRR)
Study ContactPamela U. Freda
Last updated: June 24, 2005
Sourced from a government-validated database.Claim as a partner

Study start date: September 1, 1999

Actual date on which the first participant was enrolled.

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.

NCT00005100
Principal SponsorNational Center for Research Resources (NCRR)
Study ContactPamela U. Freda
Last updated: June 24, 2005
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

165 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 20 to 75 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Bone DiseasesBone Diseases, EndocrineBrain DiseasesCentral Nervous System DiseasesHyperpituitarismHypothalamic DiseasesMusculoskeletal DiseasesNervous System DiseasesPathologic ProcessesPituitary DiseasesPathological Conditions, Signs and SymptomsDisease AttributesAcromegalyEndocrine System DiseasesRare Diseases

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

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Recruiting

Columbia University College of Physicians and Surgeons

New York, United StatesOpen Columbia University College of Physicians and Surgeons in Google Maps
SuspendedOne Study Center