Status:
COMPLETED
Side Effects of Antipsychotic Medications
Lead Sponsor:
Stanford University
Conditions:
Insulin Resistance
Metabolic Syndrome X
Eligibility:
All Genders
30-66 years
Brief Summary
Medications like olanzapine have been associated with the development of weight gain and diabetes in some patients. It is not known if the increased risk of developing diabetes is a direct effect on i...
Detailed Description
Objectives: The use of atypical antipsychotics has been associated with increased weight gain, the development of type-2 diabetes, and, in rare cases, diabetic ketoacidosis. It is not clear if these c...
Eligibility Criteria
Inclusion
- Participants 30-66 years of age
- Body mass index (BMI) \>25 \< 35 kg/m2.
- Fasting plasma glucose concentration \< 126 mg/dL
- Stable on one of the following psychiatric medication: Olanzapine (Zyprexa®), Ziprasidone (Geodon®), Aripiprazole (Abilify®), or Risperidone (Risperdal®)
- Stable on psychiatric medication for at least 3 months
Exclusion
- Medications that directly affect insulin-mediated glucose disposal
- Intense suicidal impulses/intent
- Alcohol or substance abuse for 3 months.
- Major medical problems, i.e., clinically unstable medical disorder or condition; cardiovascular, hepatic, renal, gastrointestinal, pulmonary, endocrine or other systemic disease that would, in the investigator's clinical judgment interfere with the endocrine measures obtained in this study.
Key Trial Info
Start Date :
April 1 2006
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 1 2011
Estimated Enrollment :
76 Patients enrolled
Trial Details
Trial ID
NCT00363181
Start Date
April 1 2006
End Date
December 1 2011
Last Update
March 22 2021
Active Locations (1)
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1
VA Palo Alto Health Care System
Palo Alto, California, United States, 94304-1290