A Prospective Study of Outcome After Therapy for Acromegaly

• Status: Recruiting
• Trial end date: 2022-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Columbia University
• Collaborators: Icahn School of Medicine at Mount Sinai; National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Treatments: Hormones

Criteria

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.