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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2010 by Cedars-Sinai Medical Center.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Cedars-Sinai Medical Center
ClinicalTrials.gov Identifier:
NCT00921609
First received: June 15, 2009
Last updated: December 14, 2010
Last verified: December 2010
  Purpose

Acromegaly is a rare disorder characterized by excessive production of growth hormone most often by a pituitary adenoma. A pituitary adenoma is a tumor, almost always benign or non-cancerous, that grows on the pituitary, a small gland located at the base of the brain. Treatment of acromegaly usually involves surgery, medication, or radiation, but can involve a combination of these three treatments.

Subjects for this study will be recruited if they are:

  1. Adults, male or female, between the ages of 18-90.
  2. Have been diagnosed with acromegaly, based on elevated levels of growth hormone, IGF-I (a hormone made in response to growth hormone), and a pituitary adenoma visualized on an MRI.
  3. Patients would have already agreed to have their acromegaly treated with surgery prior to study entry.

Subjects will have measurements of growth hormone using an oral glucose tolerance test (OGTT), IGF-I, free IGF-I and levels of IGF binding proteins at four time points after their pituitary surgery: Day 1, Day 42 (6 weeks), Day 84 (12 weeks), and day 365 (1 year). Subjects will also have an MRI of the pituitary done at 12 weeks and 1 year. OGTT and IGF-I are routinely measured to assess whether or not a person is cured of their acromegaly. An MRI of the pituitary is routinely done at 12 weeks and 1 year after surgery to assess the results of surgery. Free IGF-I and IGF binding proteins are not routinely measured after surgery, but are being done to see if they relate more strongly to disease activity than IGF-I and growth hormone.

OGTT and the IGF-I binding proteins are not routinely measured on the day after surgery, but are being done to examine the predictive ability of these tests at a very early time after surgery. Data obtained from these tests will be compared to the data gathered at the 1 year time point.

IGF-I and growth hormone will be measured by a commercial clinical lab, Quest Diagnostics, for clinical decision-making at the time of service. IGF-I and growth hormone will also be measured using other methods to attempt to investigate the variability of these hormones when different assays are used.


Condition Intervention
Acromegaly
Other: OGTT

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Cedars-Sinai Medical Center:

Primary Outcome Measures:
  • 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. [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • A second objective of the study will be to determine the reliability of GH nadir to OGTT, free IGF-I, total IGF-I, and IGF binding proteins on post-operative day 1 in predicting long-term cure outcomes in acromegaly. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • A third objective will be to determine inter-assay variability in the measurement of GH and IGF-I levels. [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: June 2006
Estimated Study Completion Date: October 2011
Groups/Cohorts Assigned Interventions
Acromegaly peri- and post-op patients
All patients will undergo the same procedures throughout the study.
Other: OGTT
An OGTT is a test that lowers growth hormone in the body to very low levels for a short time in order to see how low the growth hormone levels are in your blood.

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Enrollment will include subjects diagnosed with acromegaly caused by GH secreting adenomas who undergo surgical treatment for their disease provided they meet all inclusion/exclusion criteria.

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00921609

Contacts
Contact: Lori Korsakoff, RN 310-423-2411 korsakoffl@cshs.org
Contact: Billy Gellepis 310-423-3395 Billy.Gellepis@cshs.org

Locations
United States, California
Cedars-Sinai Medical Center, Pituitary Center Recruiting
Los Angeles, California, United States, 90048
Sponsors and Collaborators
Cedars-Sinai Medical Center
Investigators
Principal Investigator: John Carmichael, MD Cedars-Sinai Medical Center
  More Information

No publications provided

Responsible Party: John Carmichael, MD / Attending Physician, Cedars-Sinai Medical Center
ClinicalTrials.gov Identifier: NCT00921609     History of Changes
Other Study ID Numbers: 8997
Study First Received: June 15, 2009
Last Updated: December 14, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Cedars-Sinai Medical Center:
Acromegaly
OGTT
post-op

Additional relevant MeSH terms:
Pituitary Diseases
Acromegaly
Bone Diseases, Endocrine
Bone Diseases
Musculoskeletal Diseases
Hyperpituitarism
Hypothalamic Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on October 01, 2014