A Prospective Study of Outcome After Therapy for Acromegaly

Acromegaly Clinical Trial

Official title:

A Prospective Study of Outcome After Therapy for Acromegaly

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01809808
• Other study ID #: AAAA0890
• Secondary ID: R56DK064720
• Status: Active, not recruiting
• Start date: September 2003
• Est. completion date: June 2025

Study information

• Verified date: October 2022
• Source: Columbia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 250
• Est. completion date: June 2025
• Est. primary completion date: June 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acromegaly

Intervention

Procedure:
• Surgery for acromegaly
(non-experimental) standard procedure

Drug:
• Medications for acromegaly
(non-experimental) standard procedure

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.

Locations

Country	Name	City	State
United States	Neuroendocrine Unit; Columbia University Medical Center, 180 Fort Washington Avenue 9-970	New York	New York

Sponsors (3)

Lead Sponsor	Collaborator
Columbia University	Icahn School of Medicine at Mount Sinai, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Visceral Adipose Tissue Mass	Total Body Magnetic Resonance Imaging	Before therapy, 6 months, 1 year and 2 years after the intervention, surgery or medical therapy.
Secondary	Intra-hepatic Lipid	Proton magnetic resonance spectroscopy of liver	Before therapy, 6 months, 1 year and 2 years after the intervention, surgery or medical therapy.
Secondary	Resting metabolic rate	Measurement of resting metabolic rate by indirect calorimetry	Before, 1 year and 2 years after the intervention
Secondary	Intra-myocellular lipid	Proton magnetic resonance spectroscopy of soleus muscle	Before therapy, 6 months, 1 year and 2 years after the intervention, surgery or medical therapy.
Secondary	Relative expression of CD11c gene	Relative expression of CD11c gene in biopsied subcutaneous adipose tissue	Before, 1 year and 2 years after the intervention
Secondary	Relative expression of CD68 gene	Relative expression of CD68 gene in biopsied subcutaneous adipose tissue	Before, 1 year and 2 years after the intervention
Secondary	Relative expression of MCP1 gene	Relative expression of MCP1 gene in biopsied subcutaneous adipose tissue	Before, 1 year and 2 years after the intervention
Secondary	Relative expression of IL6 gene	Relative expression of IL6 gene in biopsied subcutaneous adipose tissue	Before, 1 year and 2 years after the intervention
Secondary	Plasma levels of c-reactive protein	Levels of c-reactive protein in peripheral venous blood	Before, 1 year and 2 years after the intervention
Secondary	Plasma Levels of ghrelin	Levels of ghrelin in peripheral blood	Before, 1 month, 3 months, 6 months, 1 year and 2 years after intervention
Secondary	Plasma Levels of AgRP	Levels of AgRP in peripheral blood	Before, 1 month, 3 months, 6 months, 1 year and 2 years after intervention
Secondary	Plasma Levels of GLP1	Levels of GLP1 in peripheral blood	Before, 1 month, 3 months, 6 months, 1 year and 2 years after intervention
Secondary	Serum Levels of insulin	Levels of insulin in peripheral blood	Before, 1 month, 3 months, 6 months, 1 year and 2 years after intervention
Secondary	Serum Levels of glucose	Levels of glucose in peripheral blood	Before, 1 month, 3 months, 6 months, 1 year and 2 years after intervention
Secondary	Serum Levels of glucagon	Levels of glucagon in peripheral blood	Before, 1 month, 3 months, 6 months, 1 year and 2 years after intervention
Secondary	Serum Levels of GIP	Levels of GIP in peripheral blood	Before, 1 month, 3 months, 6 months, 1 year and 2 years after intervention

External Links

•   Columbia University Medical Center: Neuroendocrine Diseases Program