NCT00638287

Brief Summary

The purpose of this study is to demonstrate the degree of variability in commercially available assays for Growth Hormone measurement in the context of clinical decision making for Growth Hormone (GH) deficiency and Acromegaly and to determine variability among IGF-I inter-assay samples obtained at the time of Growth-Hormone Releasing Hormone Arginine Testing and Oral Glucose Tolerance Testing.

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
171

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2007

Typical duration for all trials

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2007

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 11, 2008

Completed
2 months until next milestone

First Posted

Study publicly available on registry

March 19, 2008

Completed
2.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2011

Completed
Last Updated

October 6, 2008

Status Verified

September 1, 2008

First QC Date

January 11, 2008

Last Update Submit

October 3, 2008

Conditions

AcromegalyGrowth Hormone Deficiency

Keywords

Subjects with pituitary disease undergoing testing for GHdeficiencySubjects with suspicion for (or diagnosis of) acromegalyundergoing OGTT testingNormal controls without evidence of pituitary dysfunction

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

tertiary referral center

You may qualify if:

  • Male or Female age 18+
  • Clinical indication for testing GH response to secretagogue testing to evaluate for GHD OR clinical indication for testing for GH response to oral glucose load (75grams of glucose) to evaluate for Acromegaly either for diagnosis OR normal volunteer for control group.
  • Normal volunteers will be screened for evidence of pituitary endocrine dysfunction prior to Oral Glucose Tolerance Testing (OGTT) and Growth Hormone Releasing Hormone - Arginine Testing (GHRH-ARG).
  • Able to provide informed consent

You may not qualify if:

  • Subjects taking GH
  • Pregnant or breast feeding

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Biospecimen

Retention: SAMPLES WITH DNA

1. Group I Growth Hormone Deficiency (GHD): subjects with pituitary disease undergoing testing for GH deficiency: GHRH-ARG Test, collect total of 84 cc whole blood. 2. Group II Acromegaly: subjects with suspicion for (or diagnosis of) acromegaly undergoing OGTT Test, collect total of 48 cc whole blood. 3. Group III Normal Controls: subjects without evidence of pituitary dysfunction undergoing OGTT Test, collect total of 136 cc whole blood.

MeSH Terms

Conditions

AcromegalyDwarfism, Pituitary

Condition Hierarchy (Ancestors)

Bone Diseases, EndocrineBone DiseasesMusculoskeletal DiseasesHyperpituitarismPituitary DiseasesHypothalamic DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesEndocrine System DiseasesDwarfismBone Diseases, DevelopmentalHypopituitarism

Study Officials

  • John Carmichael, MD

    Cedars-Sinai Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 11, 2008

First Posted

March 19, 2008

Study Start

November 1, 2007

Study Completion

January 1, 2011

Last Updated

October 6, 2008

Record last verified: 2008-09