Mifepristone for Metabolic Syndrome
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ClinicalTrials.gov Identifier: NCT01419535 |
Recruitment Status
:
Completed
First Posted
: August 18, 2011
Last Update Posted
: March 29, 2018
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Tracking Information | ||||
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First Submitted Date ICMJE | August 17, 2011 | |||
First Posted Date ICMJE | August 18, 2011 | |||
Last Update Posted Date | March 29, 2018 | |||
Study Start Date ICMJE | August 17, 2011 | |||
Actual Primary Completion Date | November 29, 2017 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
To change in insulin sensitivity index based on the effect of insulin on glucose during frequently sampled IV glucose tolerance test (FSIVGTT) | |||
Original Primary Outcome Measures ICMJE |
Lipid response to mifepristone | |||
Change History | Complete list of historical versions of study NCT01419535 on ClinicalTrials.gov Archive Site | |||
Current Secondary Outcome Measures ICMJE |
Whole-body rate of regenerating cortisol response to mifepristone of glucose insulin sensitivity, free fatty acid clearance, cortisol metabolites, adrenal hormones. | |||
Original Secondary Outcome Measures ICMJE | Same as current | |||
Current Other Outcome Measures ICMJE | Not Provided | |||
Original Other Outcome Measures ICMJE | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | Mifepristone for Metabolic Syndrome | |||
Official Title ICMJE | Effects of the Glucocorticoid Antagonist, Mifepristone, on Glucose Intolerance in Obese and Overweight Individuals | |||
Brief Summary | Background:
Objectives: - To study the effects of short-term mifepristone treatment for metabolic syndrome. Eligibility: - Men and Women between 35 and 70 years of age are overweight or obese, and have abnormal glucose and triglyceride levels. Design:
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Detailed Description | The hormone cortisol is a key regulator of metabolism that influences the use of glucose (sugar) and fat as fuels. Persistently increased cortisol levels, as in Cushing s syndrome, lead to obesity, type 2 diabetes mellitus and lipid abnormalities including elevated triglyceride levels and low high-density lipoprotein (HDL) levels. These same disorders are also present in patients without Cushing s syndrome, suggesting that cortisol may be involved in their pathogenesis. Mifepristone is a cortisol-like drug that blocks cortisol action in the body. It can reverse lipid abnormalities, diabetes and obesity in Cushing s syndrome patients but its effects on these conditions have not been tested in patients without the syndrome. The long-term aim of this clinical trial is to evaluate the ability of mifepristone to reverse or improve glucose intolerance, dyslipidemia, hypertension and weight gain. An initial 7-day prospective, randomized, placebo-controlled, crossover study is proposed here to look at the effect of short-term administration of oral mifepristone or placebo on glucose intolerance. Given that there are no human data available on the effect of mifepristone on insulin sensitivity, this will be a pilot study of 15 subjects. Data from this study will then be used to design a larger trial to evaluate long-term effects on blood pressure and weight, as well as glucose and triglyceride control. Overweight or obese subjects with abnormal glucose tolerance will undergo each of the two treatments in a randomized order, including mifepristone by mouth and a look-alike inert tablet by mouth. Each treatment study will include two or three days of baseline tests that will be repeated after seven days of treatment. Treatments will be separated by at least six and no more than eight weeks. The tests will include blood drawing, urine collection, administration of glucose and insulin by vein, and a cortisol-like material to evaluate the metabolism of cortisol and a related hormone, corticosterone. |
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Study Type ICMJE | Interventional | |||
Study Phase | Phase 1 Phase 2 |
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Study Design ICMJE | Allocation: Randomized Intervention Model: Crossover Assignment Primary Purpose: Treatment |
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Condition ICMJE |
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Intervention ICMJE | Drug: Mifepristone | |||
Study Arms | Not Provided | |||
Publications * |
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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 ICMJE | Completed | |||
Actual Enrollment ICMJE |
63 | |||
Original Estimated Enrollment ICMJE |
40 | |||
Actual Study Completion Date | November 29, 2017 | |||
Actual Primary Completion Date | November 29, 2017 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE |
EXCLUSION CRITERIA:
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Sex/Gender |
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Ages | 35 Years to 70 Years (Adult, Senior) | |||
Accepts Healthy Volunteers | Yes | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT01419535 | |||
Other Study ID Numbers ICMJE | 110208 11-CH-0208 |
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Has Data Monitoring Committee | Not Provided | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement | Not Provided | |||
Responsible Party | National Institutes of Health Clinical Center (CC) ( Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) ) | |||
Study Sponsor ICMJE | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | National Institutes of Health Clinical Center (CC) | |||
Verification Date | November 29, 2017 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |