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Peri-operative Dynamics of the Growth Hormone Axis in Subjects With Acromegaly

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ClinicalTrials.gov Identifier: NCT00921609
Recruitment Status : Recruiting
First Posted : June 16, 2009
Last Update Posted : July 29, 2020
Sponsor:
Information provided by (Responsible Party):
Odelia Cooper, Cedars-Sinai Medical Center

Brief Summary:

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 or disease Intervention/treatment
Acromegaly Diagnostic Test: Oral glucose tolerance test

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Study Type : Observational
Estimated Enrollment : 20 participants
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
Study Start Date : June 2006
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hormones

Group/Cohort Intervention/treatment
Acromegaly patients
All patients will undergo oral glucose tolerance test at postoperative day 1, 6 weeks, 3 months, and 1 year
Diagnostic Test: Oral glucose tolerance test
An oral glucose tolerance test 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.




Primary Outcome Measures :
  1. Correlation of normalization of Growth hormone postoperatively with 1 year remission rates [ Time Frame: 1 year ]
    The primary endpoint will be to assess if a higher proportion of subjects in group 2b (low normal IGF-1 and elevated GH) normalize their GH nadir responses to OGTT than subjects in group 2a (high normal IGF-1 and elevated GH) at either the three month time point or 12 month time point.


Secondary Outcome Measures :
  1. Predictor of remission [ Time Frame: 1 year ]
    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.

  2. Assay variability of IGF-1 and GH [ Time Frame: 1 year ]
    A third objective will be to determine inter-assay variability in the measurement of GH and IGF-I levels.


Biospecimen Retention:   Samples Without DNA
1 ml frozen serum saved to run free IGF-1


Information from the National Library of Medicine

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, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00921609


Contacts
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Contact: Vivian Hwe, BS 424-315-4489 hwev@cshs.org

Locations
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United States, California
Cedars-Sinai Medical Center, Pituitary Center Recruiting
Los Angeles, California, United States, 90048
Sponsors and Collaborators
Cedars-Sinai Medical Center
Investigators
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Principal Investigator: Odelia Cooper, MD Cedars-Sinai Medical Center
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Responsible Party: Odelia Cooper, Associate Professor of Medicine, Division of Endocrinology, Diabetes, and Metabolism, Cedars-Sinai Medical Center
ClinicalTrials.gov Identifier: NCT00921609    
Other Study ID Numbers: 8997
First Posted: June 16, 2009    Key Record Dates
Last Update Posted: July 29, 2020
Last Verified: July 2020
Keywords provided by Odelia Cooper, Cedars-Sinai Medical Center:
Acromegaly
OGTT
post-op
Additional relevant MeSH terms:
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Acromegaly
Bone Diseases, Endocrine
Bone Diseases
Musculoskeletal Diseases
Hyperpituitarism
Pituitary Diseases
Hypothalamic Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Endocrine System Diseases