Phase 4 N=20 Randomized Triple-blind Prevention

Rosiglitazone for Clozapine Induced Glucose Metabolism Impairment

Schizophrenia

Bottom Line

View on ClinicalTrials.gov: NCT00337350 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Mar 2013

Primary outcome: Primary: Change From Baseline in Insulin Sensitivity — 3.2; 0.4 microUnits/mL — p=0.08

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: rosiglitazone (Drug); placebo (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Massachusetts General Hospital
Primary completion: Jan 2011

Outcome Measures

Outcome	Result	p-value
PRIMARY Change From Baseline in Insulin Sensitivity	3.2; 0.4	0.08
PRIMARY Change From Baseline on Glucose Utilization (SG)	.002; -0.01	.05
PRIMARY Change From Baseline in Acute Insulin Response to Glucose (AIRG)	-151; 19	0.21

Summary

We propose an eight-week, double-blind, placebo-controlled trial of rosiglitazone in schizophrenia subjects treated with clozapine using Bergman's Minimal Model (MINMOD) intravenous glucose tolerance test. Bergman's Minimal Model analysis with frequent sampled intravenous glucose tolerance test (FSIVGTT) provides a sensitive and reliable method to measure glucose effectiveness, insulin secretion and insulin sensitivity. The MINMOD determines the relationship between insulin sensitivity, insulin secretion and the degree of obesity and can be used to study drug effects upon these variables.

Eligibility Criteria

Inclusion Criteria

Male or female
Age 18-65 years
Diagnosis of schizophrenia, any subtype, schizoaffective disorder, any subtype or schizophreniform disorder
Well established compliance with out-patient medications
Current treatment with clozapine for a minimum of one year
Evidence of insulin resistance: impaired fasting glucose (glucose ≥100 mg/dl) or hyperinsulinemia (fasting insulin ≥ 15 ng/dl) or a HOMA-IR (homeostasis model assessment for insulin resistance) (fasting glucose X fasting insulin/22.5) ≥2 or a SI (insulin sensitivity index)

Exclusion Criteria

Inability to provide informed consent
Current substance abuse
Significant medical illness, including congestive heart failure, severe cardiovascular disease, renal disease (serum creatinine > 1.5), anemia (Hemoglobin 2.0X upper limit of normal) If at any time, ALT increases to 2X ULN, the subject's participation in the study will be terminated.
Women of child bearing potential who are pregnant, breastfeeding, or who are unwilling or unable to use an effective form of birth control during the entire study
Treatment with agents that induce weight loss
History of diabetes mellitus or thyroid disease
Current treatment with an oral hypoglycemic agent or insulin
Known hypersensitivity to rosiglitazone or any of its components
Fasting Glucose >126 mg/dL11. Treatment with other atypical antipsychotic agents thought to impair glucose metabolism (olanzapine) or low potency conventional agents (thioridazine, chlorpromazine)

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Data sourced from ClinicalTrials.gov (NCT00337350). 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.