N/A
N=96
Glucose and Lipid Metabolism on Antipsychotic Medication
Schizophrenia · Schizoaffective Disorder · Type 2 Diabetes Mellitus · Hyperglycemia
Bottom Line
View on ClinicalTrials.gov: NCT00515723 ↗Enrolled (actual)
96
Serious AEs
0.0%
Results posted
Oct 2019
Primary outcome: Primary: DEXA Total Fat — 32.24; 27.66; 28.83; 31.60 kilograms of body fat — p=0.002
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- risperidone (Drug); olanzapine (Drug); quetiapine (Drug); ziprasidone (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Washington University School of Medicine
- Primary completion
- Dec 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY DEXA Total Fat |
32.24; 27.66; 28.83; 31.60; 30.25; 34.38 | 0.002 sig |
| PRIMARY Clamp Derived Insulin Sensitivity (mg/kg/Min) |
4.39; 5.53; 5.28; 4.33; 4.82; 3.62 | 0.05 |
Summary
This project aims to a) evaluate the effects of selected antipsychotic medications on insulin action in skeletal muscle (glucose disposal), liver (glucose production) and adipose tissue (whole-body lipolysis), b) evaluate the effects of selected antipsychotic medications on abdominal adipose tissue mass, total body fat and total fat-free mass, and c) explore the longitudinal effects of treatment with selected antipsychotics on glucose tolerance, lipid profiles, abdominal adipose tissue mass, total body fat and total fat-free mass. These hypotheses will be evaluated by measuring 1) whole-body glucose and lipid kinetics with the use of "gold-standard" stable isotope tracer methodology, 2) body composition using dual energy x-ray absorptiometry and magnetic resonance imaging, and 3) longitudinal changes in glucose tolerance and lipid profiles. The aims will be addressed in non-diabetic schizophrenia patients chronically treated with risperidone, olanzapine, clozapine, quetiapine, ziprasidone, or haloperidol, and untreated healthy controls. Re-evaluations will also be performed in patients who are randomized to switch from their current antipsychotic (from the above groups) to risperidone, olanzapine, quetiapine, or ziprasidone for 6 months. Relevant data is critically needed to target basic research, identify long-term cardiovascular consequences, and plan therapeutic interventions.
Eligibility Criteria
Inclusion Criteria
- Aged 18-60 years
- Patients: otherwise healthy and meets DSM-IV criteria for schizophrenia or schizoaffective disorder, any type, treated with haloperidol, olanzapine, clozapine, quetiapine, ziprasidone, aripiprazole, or risperidone for at least 3 months
- Controls: healthy
- Able to give informed consent
- No antipsychotic medication changes for 3 months, and no other medication changes for 2 weeks prior to Baseline Evaluations.
Exclusion Criteria
- Axis I psychiatric disorder criteria met in self except for substance use disorders as below
- Patients and controls: meets DSM-IV criteria for the diagnoses of substance abuse within the past 3 months
- Involuntary legal status (as per Missouri law)
- The presence of any serious medical disorder that may confound the assessment of relevant biologic measures or diagnosis, including: significant organ system dysfunction, metabolic diseases, type 1 diabetes mellitus, symptomatic type 2 diabetes mellitus (see below), pregnancy, endocrine disease, coagulopathy, clinically significant anemia, that would preclude blood sampling (as determined by the PI) or acute infection;
- Patients taking more than one atypical antipsychotic medication;
- Subjects taking certain prescription medications (as determined by PI on a case by case basis).
Data sourced from ClinicalTrials.gov (NCT00515723). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.