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NCT01419535 · ClinicalTrials.gov registry record · Phase 1
Mifepristone Effects on Glucose Intolerance in Obese/Overweight Adults
A Phase 1 study of Diabetes and Endocrine Disease, sponsored by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).
- Completed
- Registry status
- Phase 1
- Development phase
- 19
- Enrollment target
- 1
- Study location
NCT01419535 is a Phase 1 study of Diabetes and Endocrine Disease that has completed, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD). The registered enrollment target is 19 participants, below the 3,028-participant average among 338 other Diabetes trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state.
The verdict
NCT01419535, a Phase 1 study of Diabetes and Endocrine Disease, has completed, sponsored by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 19 participants
- Enrollment target
- 1
- Study location
Study Summary
Background: * Metabolic syndrome is a name given to a group of factors that tend to occur together. These risk factors include central obesity (extra weight around the middle of the body) and high blood pressure and blood sugar levels. They also include low levels of HDL ("good cholesterol") and high triglyceride levels. A person is said to have metabolic syndrome if they have three or more of the above risk factors. People with metabolic syndrome are at increased risk for type 2 diabetes, stroke, and heart disease. * Cortisol, a hormone produced by the adrenal glands, is an important regulator of metabolism. People with central obesity and metabolic syndrome may have higher than normal cortisol levels that the body cannot regulate properly. Abnormal cortisol levels may play an important role in metabolic syndrome. Mifepristone is a drug that blocks cortisol. Researchers are interested in studying its effects on metabolic syndrome. 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: * Participants will be screened with a physical exam and medical history. They will also have blood and urine tests. * Participants will be admitted to the metabolic unit at the National Institutes of Health Clinical Center for the first 3 days of the study: * Day 1: Body measurements (height, weight, waist, hip, and neck) and blood pressure tests. Also, 24 hours of regular blood draws and 24-hour urine collection to monitor regular daily cortisol levels. * Day 2: Glucose/insulin infusion test to measure blood sugar levels. * Day 3: Infusion of cortisol-like compounds and then regular blood draws for about 3 hours to evaluate how cortisol is metabolized. * At the end of Day 3, participants will receive mifepristone or a look-alike capsule to take for 7 days at home. * After 7 days, participants
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Mifepristone
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center, 9000 Rockville Pike - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 19 participants |
| Start Date | 2011-11-29 |
| Est. Completion | 2015-11-24 |
| Phase | Phase 1 |
Sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)305 total trials
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01419535
The ClinicalTrials.gov registry entry for NCT01419535 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 19 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 3,028-participant average among 338 other Diabetes trials with a reported enrollment target (99% lower). The listed sponsor is Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), which has 305 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Diabetes appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT01419535 reports 1 study location spanning 1 distinct geographic area - top geographies include Maryland.
Frequently Asked Questions
What is clinical trial NCT01419535 about?
NCT01419535 is a clinical study titled "Mifepristone Effects on Glucose Intolerance in Obese/Overweight Adults". Background: * Metabolic syndrome is a name given to a group of factors that tend to occur together. These risk factors include central obesity (extra weight around the middle of the body) and high blood pressure and blood sugar levels. They also include low levels of HDL ("good cholesterol") and hi...
What is the current status of trial NCT01419535?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 19 participants. The study started on 2011-11-29. Estimated completion is 2015-11-24.
What conditions does trial NCT01419535 study?
This clinical trial studies the following conditions: Diabetes, Endocrine Disease.
What interventions are being tested in trial NCT01419535?
The interventions under investigation include: Placebo (DRUG), Mifepristone (DRUG).
Who is sponsoring clinical trial NCT01419535?
This trial is sponsored by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), which has 305 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01419535 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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