Rosiglitazone for Clozapine Induced Glucose Metabolism Impairment

Completed · Phase 4 · Has a placebo group

Conditions studied: Schizophrenia

In brief

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.

Key facts

Study ID: NCT00337350
Run by: Massachusetts General Hospital
People needed: 20
Starts: 2003-09-01
Expected to finish: 2011-01-01
Last updated by the study team: 2015-05-08

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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)

You may not qualify if…

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 < 11.0 gm/dL) or psychiatrically unstable
Severe hepatic impairment, active liver disease or increased serum transaminase levels (ALT>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)

Where it is running

Massachusetts General Hospital Schizophrenia Program — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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