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
| 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 :
- 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 :
- 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 |
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).
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| Original Primary Outcome Measures | Same as current | ||||
| Change History | No Changes Posted | ||||
| Current Secondary Outcome Measures |
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
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| 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 |
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| 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
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| Study Groups/Cohorts | Not Provided | ||||
| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status | Unknown status | ||||
| Estimated Enrollment |
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:
Exclusion Criteria:
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| Sex/Gender |
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| 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 |
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| IPD Sharing Statement |
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| Responsible Party | Gabrielle Page-Wilson, Columbia University | ||||
| Study Sponsor | Columbia University | ||||
| Collaborators | New York Obesity and Nutrition Research Center | ||||
| Investigators |
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| PRS Account | Columbia University | ||||
| Verification Date | January 2019 | ||||
