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出境医 / 临床实验 / Cushing's Lipodystrophy

Cushing's Lipodystrophy

Study Description
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
Layout table for study information
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
Arms and Interventions
Outcome Measures
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
Contacts and Locations
Tracking Information
First Submitted Date January 15, 2019
First Posted Date January 28, 2019
Last Update Posted Date January 28, 2019
Actual Study Start Date July 16, 2018
Estimated Primary Completion Date March 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: January 24, 2019)
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).
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: January 24, 2019)
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
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Cushing's Lipodystrophy
Official Title Novel Mediators of the Lipodystrophy and Metabolic Consequences of Cushing's Disease
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients with ACTH-dependent Cushing's syndrome
Condition Cushing's Syndrome
Intervention Procedure: Treatment of Cushing's
Surgical resection of ACTH-secreting tumor to achieve cure of hypercortisolism
Other Name: Medical treatment of hypercortisolism
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: January 24, 2019)
8
Original Estimated Enrollment Same as current
Estimated Study Completion Date March 2020
Estimated Primary Completion Date March 2020   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03817840
Other Study ID Numbers AAAR7901
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Gabrielle Page-Wilson, Columbia University
Study Sponsor Columbia University
Collaborators New York Obesity and Nutrition Research Center
Investigators
Principal Investigator: Gabrielle Page-Wilson, MD Columbia University
PRS Account Columbia University
Verification Date January 2019