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A Study Examining the Peri- and Post-operative Dynamics of the GH-IGF-1 Axis in Subjects With Acromegaly During the First Year After Surgical Resection


N/A
18 Years
90 Years
Open (Enrolling)
Both
Acromegaly

Thank you

Trial Information

A Study Examining the Peri- and Post-operative Dynamics of the GH-IGF-1 Axis in Subjects With Acromegaly During the First Year After Surgical Resection


Inclusion Criteria:



- Male or Female age 18-90

- Diagnosed with acromegaly from a pituitary adenoma visualized by MRI, and with
elevated IGF-1 levels compared to age and gender matched control values and nadir GH
response to OGTT>1mg/L

- Having already agreed to undergo surgical resection of their pituitary adenoma prior
to study entry

- Must provide informed consent

Exclusion Criteria:

- Inability to complete the protocol due to intercurrent medical or psychiatric illness

- Pregnant or breastfeeding

- Use of insulin

- Use of estrogen, progesterone, testosterone or thyroid hormone will be allowed as
long as the dose is stable during the study

Type of Study:

Observational

Study Design:

Observational Model: Case-Only, Time Perspective: Prospective

Outcome Measure:

The primary objective of this study will be to determine the natural course of acromegaly treated with surgery in subjects with non-suppressed GH nadir values and normal total IGF-I values.

Outcome Time Frame:

1 year

Safety Issue:

No

Principal Investigator

John Carmichael, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Cedars-Sinai Medical Center

Authority:

United States: Institutional Review Board

Study ID:

8997

NCT ID:

NCT00921609

Start Date:

June 2006

Completion Date:

October 2011

Related Keywords:

  • Acromegaly
  • Acromegaly
  • OGTT
  • post-op
  • Acromegaly

Name

Location
Cedars-Sinai Medical Center, Pituitary Center Los Angeles, California  90048