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NCT00337350 · ClinicalTrials.gov registry record · Phase 4
Rosiglitazone for Clozapine Induced Glucose Metabolism Impairment
A Phase 4 study, sponsored by Massachusetts General Hospital.
- Completed
- Registry status
- Phase 4
- Development phase
- 20
- Enrollment target
NCT00337350: Completed Phase 4 study, sponsored by Massachusetts General Hospital.
NCT00337350 is a Phase 4 study that has completed, run by Massachusetts General Hospital. The registered enrollment target is 20 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (96% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00337350, a Phase 4 study, has completed, sponsored by Massachusetts General Hospital.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 20 participants
- Enrollment target
Study 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.
Primary Outcome
Insulin Sensitivity (IS) was assessed using a Frequently Sampled Intravenous Glucose Tolerance Test (FSIVGTT), performed at Baseline and at week 8 (study endpoint). Subjects in the Rosiglitazone treatment arm were compared to subjects in the placebo treatment arm on their change in IS between Baseline and week 8. SI was calculated from plasma glucose and serum insulin values using the MINMOD Millennium computer program. SI represents the increase in net fractional glucose clearance rate per unit
Interventions
- DRUG placebo
- DRUG rosiglitazone
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2003-09 |
| Est. Completion | 2011-01 |
| Phase | Phase 4 |
What the finished NCT00337350 record still lists
NCT00337350 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (96% lower).
The record links to 0 conditions, and to 2 interventions - of which placebo is the first listed.
NCT00337350 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00337350 about?
NCT00337350 is a clinical study titled "Rosiglitazone for Clozapine Induced Glucose Metabolism Impairment". 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 (FSI...
What is the current status of trial NCT00337350?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 20 participants. The study started on 2003-09. Estimated completion is 2011-01.
What interventions are being tested in trial NCT00337350?
The interventions under investigation include: placebo (DRUG), rosiglitazone (DRUG).
Who is sponsoring clinical trial NCT00337350?
This trial is sponsored by Massachusetts General Hospital, which has 2,032 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00337350's enrollment target sits among peer trials
20 1753rd of 2000 higher than 167 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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