Glucose and Lipid Metabolism on Antipsychotic Medication (Glulipid)
Glucose and Lipid Metabolism on Antipsychotic Medication (Glulipid)
This study is currently recruiting participants.
Verified by Washington University School of Medicine, August 2007
Sponsors and Collaborators: Washington University School of Medicine
National Institutes of Health (NIH)
Information provided by: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT00515723
Purpose
Hyperglycemia and type 2 diabetes mellitus are more common in schizophrenia than in the general population. Type 2 diabetes mellitus is characterized by disturbances in insulin action on skeletal muscle, liver and adipose tissue. Diabetes causes increased morbidity and mortality due to acute (e.g., diabetic ketoacidosis) and long-term (e.g., cardiovascular disease) complications. The combination of hyperglycemia, dyslipidemia and abdominal adiposity is even more strongly associated with increased cardiovascular morbidity and mortality. The association of type 2 diabetes and hyperglycemia with schizophrenia was first noted prior to the introduction of antipsychotic medications, suggesting that these patients may be at increased risk. Since then, however, additional glucoregulatory abnormalities (e.g., new onset diabetes), dyslipidemia, and increased weight and adiposity have all been associated with antipsychotic medications. Concern about antipsychotic effects on glucose, lipids and adiposity has increased recently, focusing on the widely-used newer medications, clozapine and olanzapine. Increased abdominal adiposity can secondarily decrease insulin sensitivity and antipsychotics can increase adiposity. However, medication effects on glucose control and insulin action may also occur independent of differences in adiposity. 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.
Condition Intervention Phase
Schizophrenia
Schizoaffective Disorder
Type 2 Diabetes Mellitus
Hyperglycemia
Drug: risperidone
Drug: olanzapine
Drug: quetiapine
Drug: ziprasidone
Phase IV
MedlinePlus related topics: Diabetes Obesity Schizophrenia
Drug Information available for: Risperidone Quetiapine Quetiapine fumarate Olanzapine Ziprasidone Ziprasidone hydrochloride Ziprasidone mesylate Dextrose Lipids
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety Study
Official Title: Glucose and Lipid Metabolism on Antipsychotic Medication
Further study details as provided by Washington University School of Medicine:
Estimated Enrollment: 120
Study Start Date: September 2001
Estimated Study Completion Date: September 2010
Eligibility
Ages Eligible for Study: 18 Years to 60 Years
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No
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).
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00515723
Contacts
Contact: Julie Schweiger 314-362-3153 schweigj@psychiatry.wustl.edu
Contact: Elizabeth Westerhaus 314-747-1134 westerhe@psychiatry.wustl.edu
Locations
United States, Missouri
Washington Univeristy School of Medicine Recruiting
St. Louis, Missouri, United States, 63110
Contact: Julia Schweiger 314-362-3153 schweigj@psychiatry.wustl.edu
Contact: Angela Stevens 314-362-2459 stevensa@psychiatry.wustl.edu
Washington University School of Medicine, Psychiatry Dept. Recruiting
St. Louis, Missouri, United States, 63110
Contact: Brenda Rosen 314-362-5939 rosenb@psychiatry.wustl.edu
Contact: Amber Spies 314-362-2465 spiesa@psychiatry.wustl.edu
Principal Investigator: John W. Newcomer, M.D.
Sub-Investigator: Dan Haupt, M.D.
Sponsors and Collaborators
Washington University School of Medicine
National Institutes of Health (NIH)
Investigators
Principal Investigator: John W Newcomer, MD Washington Univerisity Schoole of Medicine
More Information
Study ID Numbers: R01 MH063985-04
First Received: August 13, 2007
Last Updated: October 16, 2007
ClinicalTrials.gov Identifier: NCT00515723
Health Authority: United States: Institutional Review Board
