This trial is closed for enrollment.

Mifepristone for Metabolic Syndrome

Location trial

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.

 

Inclusion Criteria

  1. Men and women 35 70 years of age
  2. Subjects will be overweight or obese, with BMI ranging from 25 - 37 kg/m2.
  3. Subjects will have either impaired fasting glucose (greater than or equal to 100 mg/dL) or a 2-hour glucose value greater than or equal to 140 mg/dl during an oral glucose tolerance test (OGTT).

OR

Mild diabetes defined as patients with a Hba1c less than or equal to 7% on no medications (diet-controlled) or on a stable dose of metformin and no other hypoglycemic agents for greater than or equal to 3 months before study entry.

4. Willing and able to comply with study requirements.

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