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

NCT00921609 | Completed

• 1 other identifier: 8997
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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. 1.Adults, male or female, between the ages of 18-90.
2. 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. 3.Patients would have already agreed to have their acromegaly treated with surgery prior to study entry.

Conditions

Acromegaly

Keywords

Acromegaly; OGTT; post-op

Outcome Measures

Primary Outcomes (1)

• Correlation of normalization of Growth hormone postoperatively with 1 year remission rates

  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.

  1 year

Secondary Outcomes (2)

• Predictor of remission

  1 year

• Assay variability of IGF-1 and GH

  1 year

Study Arms (1)

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

Interventions

Oral glucose tolerance test DIAGNOSTIC_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.

Acromegaly patients

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cedars-Sinai Medical Center: lead

Study Sites (1)

Cedars-Sinai Medical Center, Pituitary Center

Los Angeles, California, 90048, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

1 ml frozen serum saved to run free IGF-1

MeSH Terms

Conditions

Acromegaly

Interventions

Glucose Tolerance Test

Condition Hierarchy (Ancestors)

Bone Diseases, Endocrine; Bone Diseases; Musculoskeletal Diseases; Hyperpituitarism; Pituitary Diseases; Hypothalamic Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Blood Chemical Analysis; Clinical Chemistry Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Endocrine; Investigative Techniques

Study Officials

• Odelia Cooper, MD

  Cedars-Sinai Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine, Division of Endocrinology, Diabetes, and Metabolism

Study Record Dates

• First Submitted: June 15, 2009
• First Posted: June 16, 2009
• Study Start: June 1, 2006
• Primary Completion: July 1, 2025
• Study Completion: July 1, 2025
• Last Updated: March 27, 2026

Record last verified: 2026-03

Locations

US (1)