Mifepristone Effects on Glucose Intolerance in Obese/Overweight Adults

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 will return to the metabolic unit to repeat the Day 1 and Day 2 study procedures. They will continue to take mifepristone.
* One week after the second set of study tests, participants will return for a brief physical exam and blood tests.
* The study procedures will be repeated after 6 to 8 weeks, with the other study drug.

Conditions

• Endocrine Disease
• Diabetes

Interventions

DRUG

Mifepristone

Mifepristone 50mg tablet by mouth every six hours for nine days.

DRUG

Placebo

Placebo (matching mifepristone 50mg tablet) by mouth every six hours for nine days.

Sponsors & Collaborators

• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

  collaborator NIH

• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

  lead NIH

Principal Investigators

• Lynnette K Nieman, M.D. · National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

CROSSOVER

Eligibility

Min Age

35 Years

Max Age

70 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2011-11-29

Primary Completion

2015-11-24

Completion

2015-11-24

FDA Drug

Yes

Countries

• United States

Study Locations