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Clinical Trial Information

Karen Teff, PhD

 

Principal Investigator: Karen Teff, Ph.D.

Title: Effect of Olanzapine and Aripiprazole on Insulin Sensitivity and Insulin Release in Healthy Control Subjects

Purpose: To determine the effect of the atypical antipsychotics on indices of glucose metabolism, independent of weight gain or psychiatric disease.

Brief Description: Following an in-depth physical screening and physical activity monitoring, healthy, normal weight subjects are admitted to the Clinical and Translational Research Center at the Hospital of the University of Pennsylvania for 12 days.  2 days of intensive metabolic testing with stable isotopes are conducted prior to and following  9 days of administration of either olanzapine, aripiprazole or placebo.

Eligibility:
      Inclusion Criteria

  1. Men and women ages 18-40
  2. BMI 19-24.5kg/m2
  3. Systolic BP <130mm Hg
  4. Diastolic BP <85mm Hg
  5. Subjects capable of giving informed consent, with no past or present psychiatric history
  6. Only women on oral contraceptives with constant dosing regimens or Depo-Provera for >3 months, to ensure uniform hormonal delivery throughout the study duration
  7. No medications except as above noted
  8. Weight stable
  9. Minimal exercise regime that includes walking, running or biking

Exclusion Criteria

  1. History of heart disease, colitis, autonomic neuropathy, hepatic or renal disease
  2. DSM-IV diagnosis of past or present psychiatric history, including clinically significant depression
  3. Drug/Alcohol dependence, homelessness, or inability to give informed consent
  4. History of asthma, congenital obstructive bladder, peptic ulcer, vasomotor instability, epilepsy, Parkinsonism, elevated thyroid hormone levels
  5. Diagnosis of diabetes
  6. BMI>25 kg/m2
  7. Prescription medication (excluding the contraceptive methods described above)
  8. Hemoglobin <11
  9. Abnormal laboratory tests which are clinically significant per the investigator
  10. Females pregnant or lactating
  11. Females: not taking hormonal contraceptives; taking hormonal contraceptives of varying dosage throughout the month
  12.  Currently on a weight loss diet
  13.  Moderate to significant exercise regime that includes swimming, weight lifting or other form of exercise not reproducible within CTRC.

Compensation:
$3000 upon completion of whole trial

Contact Info:

Name: Mike Harvey
Phone: 267 519 4858
Email: mharvey@monell.org

Click here to download study flyer

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