AcromegalyNCT01809808
A Prospective Study of Outcome After Therapy for Acromegaly
An observational study of Acromegaly, run by Columbia University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Acromegaly
- What is being tested?
- Surgery for acromegaly, Medications for acromegaly and Total body magnetic resonance imaging
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 280 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2003to Aug 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Subjects newly diagnosed with acromegaly or who have previously undergone surgery for acromegaly are invited to participate.
Who may be able to join
- 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.
- Adult males and females.
Show all 10Show fewer
- 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.
Who cannot join
- 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
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Neuroendocrine Unit; Columbia University Medical Center, 180 Fort Washington Avenue 9-970
New York, New York, 10032
About this study
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.
Read the 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.
- Conditions
- Acromegaly
- Being tested
- Surgery for acromegaly, Medications for acromegaly, Total body magnetic resonance imaging, Adipose Tissue Biopsy
- Keywords
- Acromegaly, Pituitary tumor
- Medical subject headings
- Acromegaly, Pituitary Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgery for acromegalyProcedure or surgery
(non-experimental) standard procedure
Medications for acromegalyDrug
Also called Drugs used to lower growth hormone
(non-experimental) standard procedure
Total body magnetic resonance imagingDiagnostic test
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.
Adipose Tissue BiopsyProcedure or surgery
Subjects will undergo biopsy of subcutaneous adipose tissue before and 12 and 24 months after surgery or medical therapy for acromegaly.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Surgery for acromegaly; Drug: Medications for acromegaly; Diagnostic Test: Total body magnetic resonance imaging; Procedure: Adipose Tissue Biopsy | |
| 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. Receives: Diagnostic Test: Total body magnetic resonance imaging; Procedure: Adipose Tissue Biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Biochemical activity of 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.
Measured: At 5 years after therapy for acromegaly
Secondary outcomes (16)
Visceral Adipose Tissue Mass
Total Body Magnetic Resonance Imaging
Measured: Before therapy, 6 months, 1 year and 2 years after the intervention, surgery or medical therapy.
Intra-hepatic Lipid
Proton magnetic resonance spectroscopy of liver
Measured: Before therapy, 6 months, 1 year and 2 years after the intervention, surgery or medical therapy.
Resting metabolic rate
Measurement of resting metabolic rate by indirect calorimetry
Measured: Before, 1 year and 2 years after the intervention
Intra-myocellular lipid
Proton magnetic resonance spectroscopy of soleus muscle
Measured: Before therapy, 6 months, 1 year and 2 years after the intervention, surgery or medical therapy.
Relative expression of CD11c gene
Relative expression of CD11c gene in biopsied subcutaneous adipose tissue
Measured: Before, 1 year and 2 years after the intervention
Relative expression of CD68 gene
Relative expression of CD68 gene in biopsied subcutaneous adipose tissue
Measured: Before, 1 year and 2 years after the intervention
Relative expression of MCP1 gene
Relative expression of MCP1 gene in biopsied subcutaneous adipose tissue
Measured: Before, 1 year and 2 years after the intervention
Relative expression of IL6 gene
Relative expression of IL6 gene in biopsied subcutaneous adipose tissue
Measured: Before, 1 year and 2 years after the intervention
Plasma levels of c-reactive protein
Levels of c-reactive protein in peripheral venous blood
Measured: Before, 1 year and 2 years after the intervention
Plasma Levels of ghrelin
Levels of ghrelin in peripheral blood
Measured: Before, 1 month, 3 months, 6 months, 1 year and 2 years after intervention
Plasma Levels of AgRP
Levels of AgRP in peripheral blood
Measured: Before, 1 month, 3 months, 6 months, 1 year and 2 years after intervention
Plasma Levels of GLP1
Levels of GLP1 in peripheral blood
Measured: Before, 1 month, 3 months, 6 months, 1 year and 2 years after intervention
Serum Levels of insulin
Levels of insulin in peripheral blood
Measured: Before, 1 month, 3 months, 6 months, 1 year and 2 years after intervention
Serum Levels of glucose
Levels of glucose in peripheral blood
Measured: Before, 1 month, 3 months, 6 months, 1 year and 2 years after intervention
Serum Levels of glucagon
Levels of glucagon in peripheral blood
Measured: Before, 1 month, 3 months, 6 months, 1 year and 2 years after intervention
Serum Levels of GIP
Levels of GIP in peripheral blood
Measured: Before, 1 month, 3 months, 6 months, 1 year and 2 years after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2013 (estimated)
- Study startSep 2003
- Primary completionAug 2025
- Study completionAug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for AcromegalyStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 280 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Collaborators
- Icahn School of Medicine at Mount Sinai, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Responsible party
- Principal investigator, Pamela U. Freda, Columbia University
- Investigators
- Pamela U Freda, M.D., Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01809808
- Sponsor's protocol ID
- AAAA0890
- Other IDs
- R56DK064720
- Status last verified
- Aug 2025
- First submitted
- 8 Aug 2012
- Last updated
- 26 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Freda PU, Reyes-Vidal C, Jin Z, Pugh M, Panigrahi SK, Bruce JN, Wardlaw SL. Plasma Agouti-Related Protein Levels in Acromegaly and Effects of Surgical or Pegvisomant Therapy. J Clin Endocrinol Metab. 2019 Nov 1;104(11):5453-5461. doi: 10.1210/jc.2019-01079.
PubMed 31361303Reyes-Vidal CM, Mojahed H, Shen W, Jin Z, Arias-Mendoza F, Fernandez JC, Gallagher D, Bruce JN, Post KD, Freda PU. Adipose Tissue Redistribution and Ectopic Lipid Deposition in Active Acromegaly and Effects of Surgical Treatment. J Clin Endocrinol Metab. 2015 Aug;100(8):2946-55. doi: 10.1210/jc.2015-1917. Epub 2015 Jun 2.
PubMed 26037515Reyes-Vidal C, Fernandez JC, Bruce JN, Crisman C, Conwell IM, Kostadinov J, Geer EB, Post KD, Freda PU. Prospective study of surgical treatment of acromegaly: effects on ghrelin, weight, adiposity, and markers of CV risk. J Clin Endocrinol Metab. 2014 Nov;99(11):4124-32. doi: 10.1210/jc.2014-2259. Epub 2014 Aug 19.
PubMed 25137427
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Study of Outcome After Therapy for Acromegaly
- ClinicalTrials.gov ID
- NCT01809808
- Acronym / sponsor ID
- AAAA0890
- Conditions
- Acromegaly
- Keywords
- Acromegaly, Pituitary tumor
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 280 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Collaborators
- Icahn School of Medicine at Mount Sinai, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- Sep 2003 (actual)
- Primary completion
- Aug 2025 (actual)
- Study completion
- Aug 2025 (actual)
- First posted
- 13 Mar 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acromegaly Subjects | – | Procedure: Surgery for acromegaly, Drug: Medications for acromegaly, Diagnostic Test: Total body magnetic resonance imaging, Procedure: Adipose Tissue BiopsyPeople 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. |
| Healthy Subjects | – | Diagnostic Test: Total body magnetic resonance imaging, Procedure: Adipose Tissue BiopsyPeople 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects newly diagnosed with acromegaly or who have previously undergone surgery for acromegaly are invited to participate.
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (8 listed)
- 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
- Subjects who are unwilling to comply with the procedures outlined in the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Surgery for acromegaly(non-experimental) standard procedure | Procedure or surgery | Acromegaly Subjects |
| Medications for acromegalyAlso: Drugs used to lower growth hormone(non-experimental) standard procedure | Drug | Acromegaly Subjects |
| Total body magnetic resonance imagingSubjects 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. | Diagnostic test | Acromegaly Subjects, Healthy Subjects |
| Adipose Tissue BiopsySubjects will undergo biopsy of subcutaneous adipose tissue before and 12 and 24 months after surgery or medical therapy for acromegaly. | Procedure or surgery | Acromegaly Subjects, Healthy Subjects |
Primary outcome
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.
16 secondary outcomes
Visceral Adipose Tissue Mass
Time frame: 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.
Resting metabolic rate
Time frame: 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.
Relative expression of CD11c gene
Time frame: 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 MCP1 gene
Time frame: 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
Plasma levels of c-reactive protein
Time frame: 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
Plasma Levels of AgRP
Time frame: 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
Serum Levels of insulin
Time frame: 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
Serum Levels of glucagon
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2025.
- Derived from this study: PubMed 31361303Freda PU, Reyes-Vidal C, Jin Z, Pugh M, Panigrahi SK, Bruce JN, Wardlaw SL. Plasma Agouti-Related Protein Levels in Acromegaly and Effects of Surgical or Pegvisomant Therapy. J Clin Endocrinol Metab. 2019 Nov 1;104(11):5453-5461. doi: 10.1210/jc.2019-01079.
- Derived from this study: PubMed 26037515Reyes-Vidal CM, Mojahed H, Shen W, Jin Z, Arias-Mendoza F, Fernandez JC, Gallagher D, Bruce JN, Post KD, Freda PU. Adipose Tissue Redistribution and Ectopic Lipid Deposition in Active Acromegaly and Effects of Surgical Treatment. J Clin Endocrinol Metab. 2015 Aug;100(8):2946-55. doi: 10.1210/jc.2015-1917. Epub 2015 Jun 2.
- Derived from this study: PubMed 25137427Reyes-Vidal C, Fernandez JC, Bruce JN, Crisman C, Conwell IM, Kostadinov J, Geer EB, Post KD, Freda PU. Prospective study of surgical treatment of acromegaly: effects on ghrelin, weight, adiposity, and markers of CV risk. J Clin Endocrinol Metab. 2014 Nov;99(11):4124-32. doi: 10.1210/jc.2014-2259. Epub 2014 Aug 19.
- Columbia University Medical Center: Neuroendocrine Diseases ProgramLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
Related trials for Acromegaly
RecruitingPhase 3
A Study to Assess the Efficacy and Safety of Debio 4126 in Participants With Acromegaly Previously Treated With Somatostatin Analogs
Acromegaly
RecruitingObservational study
An Investigation of Pituitary Tumors and Related Hypothalmic Disorders
Panhypopituitarism, Gigantism/Acromegaly
Recruiting
Managing Pasireotide-associated Hyperglycaemia in Acromegaly With Ketogenic Diet
Acromegaly Due to Pituitary Adenoma, Hyperglycemia
Not yet recruitingPhase 3
PRESTO: A Phase III Randomised Controlled Trial of Dose-escalated Proton Beam Therapy Versus Standard of Care Radiotherapy for Functioning Pituitary Tumours
Acromegaly Due to Pituitary Adenoma, Cushing's Disease
RecruitingObservational study
An Observational Study of Octreotide Subcutaneous Depot in Patients With Acromegaly
Acromegaly
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pamela U Freda, M.D. principal investigator
Columbia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acromegaly, run by Columbia University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Biochemical activity of Acromegaly (time frame: At 5 years after therapy for acromegaly). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01809808, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2025.