Glucose and Lipid Metabolism on Antipsychotic Medication
NCT00515723 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 96
Last updated 2019-10-02
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.
Conditions
- Schizophrenia
- Schizoaffective Disorder
- Type 2 Diabetes Mellitus
- Hyperglycemia
Interventions
- DRUG
-
risperidone
randomized to 12 week trial of risperidone.
- DRUG
-
randomized to 12 week trial of olanzapine.
- DRUG
-
quetiapine
randomized to 12 week trial of quetiapine.
- DRUG
-
ziprasidone
randomized to 12 week trial of ziprasidone.
Sponsors & Collaborators
-
National Institute of Mental Health (NIMH)
collaborator NIH -
Washington University School of Medicine
lead OTHER
Principal Investigators
-
John W Newcomer, MD · Washington Univerisity School of Medicine and Florida Atlantic University
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 60 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2001-09-30
- Primary Completion
- 2008-12-31
- Completion
- 2008-12-31
Countries
- United States
Study Locations
More Related Trials
-
Changes in Adiposity, Metabolic Measures From Atypicals to Aripiprazole
NCT00205660 ·Status: COMPLETED ·Phase: PHASE4
-
Monitoring and Management for Metabolic Side Effects of Antipsychotics
NCT01875861 ·Status: COMPLETED ·Phase: NA
-
β-Cell Function in Schizophrenic Subjects on Atypical Antipsychotic drugS
NCT00528359 ·Status: COMPLETED
-
Effect of Atypical Antipsychotic Drugs Olanzapine and Amisulpride on Glucose Metabolism
NCT01160991 ·Status: COMPLETED ·Phase: NA
-
Improving Metabolic Parameters of Antipsychotic Child Treatment With Ziprasidone, Aripiprazole, and Clozapine
NCT00617058 ·Status: TERMINATED ·Phase: PHASE2
-
Examining the Effects of Antipsychotic Medications on Insulin Sensitivity
NCT00895921 ·Status: COMPLETED ·Phase: PHASE4
-
Cross-Sectional Iloperidone IVGTT
NCT01686815 ·Status: COMPLETED
-
Acute Impact of Intramuscular (IM) Aripiprazole and Olanzapine on Insulin Resistance in High Risk Prediabetics
NCT01411930 ·Status: COMPLETED ·Phase: PHASE4
-
Effects of Adjunctive Metformin on Metabolic Profiles in Clozapine-treated Schizophrenic Patients
NCT01300637 ·Status: UNKNOWN ·Phase: NA
-
Metformin for Weight Loss in Schizophrenia
NCT01177709 ·Status: TERMINATED ·Phase: NA
-
Comparative Effectiveness of Dapagliflozin, Metformin, and Lifestyle Modification for Antipsychotic-Induced Weight Gain: An Open-Label Pragmatic Trial
NCT07342764 ·Status: NOT_YET_RECRUITING ·Phase: PHASE4
-
Aggressive Treatment of Metabolic Syndrome in Patients Receiving Clozapine for Schizophrenia
NCT00794963 ·Status: TERMINATED ·Phase: NA
-
Pfizer/IVGTT/Ziprasidone/Olanzapine
NCT00205725 ·Status: COMPLETED ·Phase: NA
-
Effect of Ziprasidone on Glucose & Plasma Lipids in Diabetes (II) and Schizophrenia or Schizoaffective Disorder
NCT00395031 ·Status: COMPLETED ·Phase: PHASE2/PHASE3
-
A Crossover Study of the Acute Effects of Olanzapine in Healthy Volunteers
NCT00741026 ·Status: COMPLETED ·Phase: NA
-
Effects of Antipsychotics on Brain Insulin Action in Females
NCT06251635 ·Status: RECRUITING ·Phase: NA
-
Anti-psychotic Medication (New Use) Weight Loss Study
NCT01272752 ·Status: WITHDRAWN ·Phase: PHASE2
-
Metabolic Effects of Subchronic Dopamine D2 Receptor Blockade by Antipsychotic Drugs in Healthy Humans
NCT00625170 ·Status: COMPLETED ·Phase: NA
-
Strategies to Reduce Antipsychotic-Associated Weight Gain in Youth
NCT00617240 ·Status: COMPLETED ·Phase: PHASE2
-
Metabolic Side-effects for Second-generation Antipsychotics
NCT01280396 ·Status: COMPLETED
-
Healthy Lifestyles for Mentally Ill People Who Have Experienced Weight Gain From Their Antipsychotic Medications - 2
NCT01052714 ·Status: COMPLETED ·Phase: NA
-
Does a GLP-1 Receptor Agonist Change Glucose Tolerance in Antipsychotic-treated Patients?
NCT01845259 ·Status: UNKNOWN ·Phase: PHASE2
-
Alleviating the Metabolic Side Effects of Antipsychotic Medications
NCT01567124 ·Status: WITHDRAWN ·Phase: PHASE4
-
The Use of Metformin in the Treatment of Antipsychotic-Induced Weight Gain in Schizophrenia (The METS Study)
NCT00816907 ·Status: COMPLETED ·Phase: PHASE4
-
DNA Diagnostics for Minimizing Metabolic Side-Effects of Antipsychotics
NCT00752960 ·Status: UNKNOWN