A Prospective Study of Outcome After Therapy for Acromegaly

NCT01809808 | Completed

• 2 other identifiers: AAAA0890R56DK064720
• Study Type: observational
• Target: 280
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Acromegaly

Keywords

Acromegaly; Pituitary tumor

Outcome Measures

Primary Outcomes (1)

• 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.

  At 5 years after therapy for acromegaly

Secondary Outcomes (16)

• Visceral Adipose Tissue Mass

  Before therapy, 6 months, 1 year and 2 years after the intervention, surgery or medical therapy.

• Intra-hepatic Lipid

  Before therapy, 6 months, 1 year and 2 years after the intervention, surgery or medical therapy.

• Resting metabolic rate

  Before, 1 year and 2 years after the intervention

• Intra-myocellular lipid

  Before therapy, 6 months, 1 year and 2 years after the intervention, surgery or medical therapy.

• Relative expression of CD11c gene

  Before, 1 year and 2 years after the intervention

Study Arms (2)

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; 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.

Diagnostic Test: Total body magnetic resonance imaging; Procedure: Adipose Tissue Biopsy

Interventions

Surgery for acromegaly PROCEDURE

(non-experimental) standard procedure

Acromegaly Subjects

Medications for acromegaly DRUG

(non-experimental) standard procedure

Also known as: Drugs used to lower growth hormone

Acromegaly Subjects

Total body magnetic resonance imaging DIAGNOSTIC_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.

Acromegaly Subjects; Healthy Subjects

Adipose Tissue Biopsy PROCEDURE

Subjects will undergo biopsy of subcutaneous adipose tissue before and 12 and 24 months after surgery or medical therapy for acromegaly.

Acromegaly Subjects; Healthy Subjects

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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
• 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.
• 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.

Sponsors & Collaborators

• Columbia University: lead
• Icahn School of Medicine at Mount Sinai: collaborator
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

Neuroendocrine Unit; Columbia University Medical Center, 180 Fort Washington Avenue 9-970

New York, New York, 10032, United States

Location

Related Publications (3)

• 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.

  PMID: 31361303 DERIVED

• Reyes-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.

  PMID: 26037515 DERIVED

• Reyes-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.

  PMID: 25137427 DERIVED

Related Links

• Columbia University Medical Center: Neuroendocrine Diseases Program

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum and blood samples

MeSH Terms

Conditions

Acromegaly; Pituitary Neoplasms

Interventions

Surgical Procedures, Operative; Dosage Forms

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; Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Hypothalamic Neoplasms; Supratentorial Neoplasms; Brain Neoplasms; Central Nervous System Neoplasms; Nervous System Neoplasms

Intervention Hierarchy (Ancestors)

Pharmaceutical Preparations; Technology, Pharmaceutical; Investigative Techniques

Study Officials

• Pamela U Freda, M.D.

  Columbia University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: August 8, 2012
• First Posted: March 13, 2013
• Study Start: September 1, 2003
• Primary Completion: August 1, 2025
• Study Completion: August 1, 2025
• Last Updated: August 26, 2025

Record last verified: 2025-08

Locations

US (1)