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Cushing's Lipodystrophy

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ClinicalTrials.gov Identifier: NCT03817840
Recruitment Status : Recruiting
First Posted : January 28, 2019
Last Update Posted : January 28, 2019
Sponsor:
Collaborator:
New York Obesity and Nutrition Research Center
Information provided by (Responsible Party):
Gabrielle Page-Wilson, Columbia University

Study Description
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Brief Summary:
This proposal will evaluate the glucocorticoid mediated changes in body fat distribution and metabolism that occur in patients with Cushing's disease. Our 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. These findings may have important implications not only for those with Cushing's disease, but for the millions of Americans who are treated with chronic glucocorticoids for an array of clinical conditions.

Condition or disease Intervention/treatment
Cushing's Syndrome Procedure: Treatment of Cushing's

Study Design
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Study Type : Observational
Estimated Enrollment : 8 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Novel Mediators of the Lipodystrophy and Metabolic Consequences of Cushing's Disease
Actual Study Start Date : July 16, 2018
Estimated Primary Completion Date : March 2020
Estimated Study Completion Date : March 2020

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Intervention Details:
  • Procedure: Treatment of Cushing's
    Surgical resection of ACTH-secreting tumor to achieve cure of hypercortisolism
    Other Name: Medical treatment of hypercortisolism

Outcome Measures
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Primary Outcome Measures :
  1. Energy Expenditure [ Time Frame: Change from baseline REE at 3 months post-treatment ]
    Resting energy expenditure (REE) will be measured by whole room indirect calorimetry prior to and following cure of Cushing's Disease (CD).


Secondary Outcome Measures :
  1. Total body adipose tissue volume [ Time Frame: Change in total body adipose tissue volume from baseline at 3 months post-treatment ]
    Whole body MRI will be utilized to measure total body adipose tissue volume


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with ACTH-dependent Cushing's syndrome
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  1. Smoking
  2. Alcohol >2 drinks/day
  3. Uncontrolled hypertension
  4. HIV given potential for lipodystrophic confounding
  5. Pregnancy and nursing
  6. Use of beta-blockers, β-adrenergic or diabetes medications other than insulin
  7. History of claustrophobia or difficulty lying flat
  8. In-dwelling metal hardware.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03817840


Contacts
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Contact: Gabrielle Page-Wilson, MD 212-305-3725 gp2287@cumc.columbia.edu

Locations
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United States, New York
Columbia University Neuroendocrine Unit Recruiting
New York, New York, United States, 10032
Contact: Gabrielle Page-Wilson, M.D.    212-305-3725    gp2287@cumc.columbia.edu   
Contact: Cara Dimino         
Sponsors and Collaborators
Columbia University
New York Obesity and Nutrition Research Center
Investigators
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Principal Investigator: Gabrielle Page-Wilson, MD Columbia University
More Information
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Responsible Party: Gabrielle Page-Wilson, Assistant Professor of Medicine, Columbia University
ClinicalTrials.gov Identifier: NCT03817840     History of Changes
Other Study ID Numbers: AAAR7901
First Posted: January 28, 2019    Key Record Dates
Last Update Posted: January 28, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Gabrielle Page-Wilson, Columbia University:
Glucocorticoids
Additional relevant MeSH terms:
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Lipodystrophy
Cushing Syndrome
Skin Diseases, Metabolic
Skin Diseases
Lipid Metabolism Disorders
 Metabolic Diseases
Adrenocortical Hyperfunction
Adrenal Gland Diseases
Endocrine System Diseases