A Prospective Study of Outcome After Therapy for Acromegaly

August 20, 2025 updated by: Pamela U. Freda, Columbia University
The purpose of this study is to evaluate hormone values and other markers of disease activity in a cohort of patients with acromegaly at the time of diagnosis and then prospectively after surgical or other treatment. This study is designed to determine blood levels of growth hormone and related hormones and cardiovascular risk markers as well as signs and symptoms of the disease at diagnosis and how these parameters change over time after surgical or other therapy. The investigators will also obtain hormonal data in a group of 50 healthy subjects who will each be studied just once with an oral glucose tolerance test (OGTT). These data will provide a comparison group to the acromegaly subjects.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Surgical removal of the pituitary tumor is the usual first form of treatment offered, but this is curative in only approximately 70% of patients. If not adequately treated, the disease can have significant morbidity largely due to the development of hypertension, diabetes and malignancy as well as possible loss of vision or other neurologic complications of a large pituitary mass. Inadequately treated acromegaly is also associated with a mortality rate 2-3 fold over the general population. All the mechanisms responsible for the increased morbidity and mortality in acromegaly as well as what biochemical criteria should be used during treatment in order to normalize the increased morbidity and mortality are not known. This study aims to follow patients with acromegaly prospectively from active disease through treatment in order to identify these factors.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
280

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10032
        • Neuroendocrine Unit; Columbia University Medical Center, 180 Fort Washington Avenue 9-970

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Subjects newly diagnosed with acromegaly or who have previously undergone surgery for acromegaly are invited to participate.

Description

Acromegaly Subjects

Inclusion Criteria:

  • Adult males and females.
  • Ages 18 and over.
  • Presenting to the PI or one of the sub-investigators for evaluation of acromegaly.
  • Must have a biochemical diagnosis of acromegaly consisting of an elevated serum insulin-like growth factor 1 (IGF-1) level. Supportive although not required for entry are an elevated growth hormone (GH) level and a failure of GH to suppress normally after oral glucose administration.
  • Willingness to participate in this study's procedures.

Exclusion Criteria:

  • Subjects who are unwilling to comply with the procedures outlined in the study.
  • Subjects who do not have the ability to fully comprehend the nature of the study, to follow instructions, and/or cooperate with study procedures
  • Are unwilling to provide informed consent to participate in the study.

Healthy Subjects

Inclusion Criteria:

  • Adult males and females.
  • Ages 18 and over.
  • Responding to ads for participation or by word of mount.
  • No medical problems, no medications, stable weight for 3 months prior to study.
  • Willingness to participate in this study's procedures.

Exclusion Criteria:

  • Subjects who are unwilling to comply with the procedures outlined in the study.
  • Subjects who do not have the ability to fully comprehend the nature of the study, to follow instructions, and/or cooperate with study procedures
  • Are unwilling to provide informed consent to participate in the study.
  • Failure to meet the inclusion criteria.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Acromegaly Subjects
People who have a biochemical diagnosis of acromegaly, and will or have already undergone surgery for acromegaly and will be taking medications for acromegaly . Subjects will undergo blood sampling, metabolic rate measurement, adipose tissue biopsy and total body magnetic resonance imaging before and over time after either surgery or medical therapy for acromegaly.
Procedure: Surgery for acromegaly
(non-experimental) standard procedure
Drug: Medications for acromegaly
(non-experimental) standard procedure
Other Names:
  • Drugs used to lower growth hormone
Diagnostic test: Total body magnetic resonance imaging
Subjects will undergo total body MRI with spectroscopy of the muscle and liver before and 3-6 months, 12 and 24 months after surgery or medical therapy for acromegaly.
Procedure: Adipose Tissue Biopsy
Subjects will undergo biopsy of subcutaneous adipose tissue before and 12 and 24 months after surgery or medical therapy for acromegaly.
Healthy Subjects
People who are not diagnosed with acromegaly, responding to flyer or by word of mouth for participation, without medical problems, not taking medications, and with a stable weight for 3 months prior to study. Subjects will undergo blood sampling, total body MRI and adipose tissue biopsy once.
Diagnostic test: Total body magnetic resonance imaging
Subjects will undergo total body MRI with spectroscopy of the muscle and liver before and 3-6 months, 12 and 24 months after surgery or medical therapy for acromegaly.
Procedure: Adipose Tissue Biopsy
Subjects will undergo biopsy of subcutaneous adipose tissue before and 12 and 24 months after surgery or medical therapy for acromegaly.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Biochemical activity of Acromegaly
Time Frame: At 5 years after therapy for acromegaly
The study will assess the status of biochemical disease activity of acromegaly before and after treatment for acromegaly. Blood samples are taken for fasting growth hormone and insulin-like growth factor 1 and growth hormone levels 60, 90 and 120 minutes after oral glucose taken at baseline visit, post-operative or after the initiation of medical therapy at month 1 (fasting blood only), month 3 (fasting blood only), month 6, month 12, and annual assessments for at least 5 years.
At 5 years after therapy for acromegaly

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Visceral Adipose Tissue Mass
Time Frame: Before therapy, 6 months, 1 year and 2 years after the intervention, surgery or medical therapy.
Total Body Magnetic Resonance Imaging
Before therapy, 6 months, 1 year and 2 years after the intervention, surgery or medical therapy.
Intra-hepatic Lipid
Time Frame: Before therapy, 6 months, 1 year and 2 years after the intervention, surgery or medical therapy.
Proton magnetic resonance spectroscopy of liver
Before therapy, 6 months, 1 year and 2 years after the intervention, surgery or medical therapy.
Resting metabolic rate
Time Frame: Before, 1 year and 2 years after the intervention
Measurement of resting metabolic rate by indirect calorimetry
Before, 1 year and 2 years after the intervention
Intra-myocellular lipid
Time Frame: Before therapy, 6 months, 1 year and 2 years after the intervention, surgery or medical therapy.
Proton magnetic resonance spectroscopy of soleus muscle
Before therapy, 6 months, 1 year and 2 years after the intervention, surgery or medical therapy.
Relative expression of CD11c gene
Time Frame: Before, 1 year and 2 years after the intervention
Relative expression of CD11c gene in biopsied subcutaneous adipose tissue
Before, 1 year and 2 years after the intervention
Relative expression of CD68 gene
Time Frame: Before, 1 year and 2 years after the intervention
Relative expression of CD68 gene in biopsied subcutaneous adipose tissue
Before, 1 year and 2 years after the intervention
Relative expression of MCP1 gene
Time Frame: Before, 1 year and 2 years after the intervention
Relative expression of MCP1 gene in biopsied subcutaneous adipose tissue
Before, 1 year and 2 years after the intervention
Relative expression of IL6 gene
Time Frame: Before, 1 year and 2 years after the intervention
Relative expression of IL6 gene in biopsied subcutaneous adipose tissue
Before, 1 year and 2 years after the intervention
Plasma levels of c-reactive protein
Time Frame: Before, 1 year and 2 years after the intervention
Levels of c-reactive protein in peripheral venous blood
Before, 1 year and 2 years after the intervention
Plasma Levels of ghrelin
Time Frame: Before, 1 month, 3 months, 6 months, 1 year and 2 years after intervention
Levels of ghrelin in peripheral blood
Before, 1 month, 3 months, 6 months, 1 year and 2 years after intervention
Plasma Levels of AgRP
Time Frame: Before, 1 month, 3 months, 6 months, 1 year and 2 years after intervention
Levels of AgRP in peripheral blood
Before, 1 month, 3 months, 6 months, 1 year and 2 years after intervention
Plasma Levels of GLP1
Time Frame: Before, 1 month, 3 months, 6 months, 1 year and 2 years after intervention
Levels of GLP1 in peripheral blood
Before, 1 month, 3 months, 6 months, 1 year and 2 years after intervention
Serum Levels of insulin
Time Frame: Before, 1 month, 3 months, 6 months, 1 year and 2 years after intervention
Levels of insulin in peripheral blood
Before, 1 month, 3 months, 6 months, 1 year and 2 years after intervention
Serum Levels of glucose
Time Frame: Before, 1 month, 3 months, 6 months, 1 year and 2 years after intervention
Levels of glucose in peripheral blood
Before, 1 month, 3 months, 6 months, 1 year and 2 years after intervention
Serum Levels of glucagon
Time Frame: Before, 1 month, 3 months, 6 months, 1 year and 2 years after intervention
Levels of glucagon in peripheral blood
Before, 1 month, 3 months, 6 months, 1 year and 2 years after intervention
Serum Levels of GIP
Time Frame: Before, 1 month, 3 months, 6 months, 1 year and 2 years after intervention
Levels of GIP in peripheral blood
Before, 1 month, 3 months, 6 months, 1 year and 2 years after intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Columbia University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Icahn School of Medicine at Mount Sinai

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Pamela U Freda, M.D., Columbia University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2003

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 8, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 11, 2013

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 13, 2013

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 26, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 20, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • AAAA0890
  • R56DK064720 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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