Novel Mediators of the Lipodystrophy and Metabolic Consequences of Cushing's Disease

NCT03817840 | Completed

• 1 other identifier: AAAR7901
• Study Type: observational
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

This proposal will evaluate the glucocorticoid mediated changes in body fat distribution and metabolism that occur in patients with Cushing's disease. The objective is to identify the mechanisms that influence both the accumulation of lipodystrophic fat and also the changes in energy expenditure and metabolism that accompany them. The study is designed to determine if the high cortisol and AgRP levels in the blood of people living with Cushing's syndrome, either from taking steroid medications or from tumors, impact body fat and metabolism by turning off brown fat, which is a type of fat that increases one's metabolism.

Conditions

Cushing's Syndrome

Keywords

Glucocorticoids

Outcome Measures

Primary Outcomes (1)

• Energy Expenditure

  Resting energy expenditure (REE) will be measured by whole room indirect calorimetry prior to and following cure of Cushing's Disease (CD).

  Change from baseline REE at 3 months post-treatment

Secondary Outcomes (1)

• Total body adipose tissue volume

  Change in total body adipose tissue volume from baseline at 3 months post-treatment

Interventions

Treatment of Cushing's PROCEDURE

Surgical resection of ACTH-secreting tumor to achieve cure of hypercortisolism

Also known as: Medical treatment of hypercortisolism

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with ACTH-dependent Cushing's syndrome

You may qualify if:

• Aged 18-70 yrs
• Body mass index (BMI) \<35 kg/m2
• Urine free cortisol (UFC) ≥150ug/d
• Pituitary tumor \>6mm on MRI or an inferior petrosal sinus sampling with central to peripheral plasma adrenocorticotropic hormone (ACTH) gradient
• Normal renal and thyroid function
• HbA1c ≤8.0.

You may not qualify if:

• Smoking
• Alcohol \>2 drinks/day
• Uncontrolled hypertension
• HIV given potential for lipodystrophic confounding
• Pregnancy and nursing
• Use of beta-blockers, β-adrenergic or diabetes medications other than insulin
• History of claustrophobia or difficulty lying flat
• In-dwelling metal hardware.

Sponsors & Collaborators

• Columbia University: lead
• New York Obesity and Nutrition Research Center: collaborator

Study Sites (1)

Columbia University Neuroendocrine Unit

New York, New York, 10032, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Subjects will undergo 4mm punch biopsies of the SC, DC, and subcutaneous abdominal fat pads under local anesthesia (lidocaine). Biopsies will be performed by an interventional radiologist or surgeon. Specimens will be prepared for histologic analysis and for immunohistochemical analysis for brown and white adipose tissue markers.

MeSH Terms

Conditions

Cushing Syndrome

Condition Hierarchy (Ancestors)

Adrenocortical Hyperfunction; Adrenal Gland Diseases; Endocrine System Diseases

Study Officials

• Gabrielle Page-Wilson, MD

  Columbia University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 15, 2019
• First Posted: January 28, 2019
• Study Start: July 16, 2018
• Primary Completion: July 1, 2021
• Study Completion: July 1, 2021
• Last Updated: June 4, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)