Improving Diabetes Risk Factors in Persons With Schizophrenia or Bipolar Disorder by Switching to Ziprasidone
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Insulin Sensitivity
研究概览
简要总结
Having a diagnosis of schizophrenia or bipolar disorder and being treated with certain of the newer antipsychotics are risk factors for development of diabetes. Subjects with these risk factors plus obesity and/or family history of diabetes who agree to study participation will undergo an oral glucose tolerance test. If the oral glucose tolerance test demonstrates that the subject is pre-diabetic (elevated glucose levels, but below the diabetic range), he/she will have his/her insulin resistance level measured, prior to random assignment to either stay on current antipsychotic medication or switch to ziprasidone. Insulin resistance will be measured again after four months. The primary hypothesis is that insulin resistance will decrease in those switched to ziprasidone relative to those continuing on their same antipsychotic medication.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of schizophrenia or schizoaffective disorder or bipolar disorder
- •BMI>29.9 or family history of diabetes and/or abdominal circumference greater than 88 cm in women or 102 cm in men
- •Pre-diabetic oral glucose tolerance test
- •Current treatment with olanzapine, risperidone, paliperidone, or quetiapine, or combination of these
- •Willing to switch to ziprasidone
- •No psychiatric hospitalizations in past three months and judged by treating clinician to be suitable for antipsychotic medication switch
- •Able to give informed consent to study
排除标准
- •Judged to be currently suicidal, homicidal, or unable to cooperate with treatment
- •Unstable serious medical illness
- •Current use of drugs that interfere with glucose and fat metabolism (sulfonylureas, metformin, thiazolidinediones). The use of "statins" and fibrates will be allowed ONLY if stable dose for past 3 months.
- •Current diagnosis of diabetes
- •Fasting blood glucose >125 mg/dl
研究组 & 干预措施
ziprasidone treatment
Subjects switch to daily oral ziprasidone from current antipsychotic(s). Dose titrated to clinically effective level.
干预措施: ziprasidone (Drug)
结局指标
主要结局
Insulin Sensitivity
时间窗: 4-5 months
Euglycemic clamp method
次要结局
- Triglycerides(4-5 months)
- Cholesterol(4-5 months)
- HDL Cholesterol(4-5 months)
- LDL Cholesterol(4-5 months)
- Body Mass Index(4-5 months)
- Abdominal Circumference(4-5 months)
- Systolic Blood Pressure(4-5 months)
- Diastolic Blood Pressure(4-5 months)
研究者
Alexander L. Miller
Principal Investigator
The University of Texas Health Science Center at San Antonio