NCT00269061已完成1 期
An Exploratory MRI Study in Type 2 Diabetic Subjects: A Randomized, Double-Blinded, Placebo-Controlled Trial to Evaluate the Measurement of Fluid Volumes by MRI in the Lower Extremities of Subjects Receiving Pioglitazone
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 2
- 主要终点
- Changes in interstitial fluid volume in the lower extremities as measured by MRI.
研究概览
简要总结
This study will use Magnetic Resonance Imaging (MRI) techniques to evaluate changes in fluid volume in the lower legs of diabetic patients who add either pioglitazone or placebo to their current diabetic regimen.
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
- Double
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Must have been diagnosed with Type 2 diabetes at least three months prior to screening.
- •Must be taking either metformin and a sulfonylurea, metformin and insulin, or insulin only, and doses of these medications must have been stable for at least three months.
- •Must have a Body Mass Index (BMI) of between 24 and
- •If female, the subject must be post-menopausal.
- •HbA1c levels must be between 7% and 10%.
- •Subjects must be eligible for MRI scanning (ie, no metal implants, pacemaker, etc).
排除标准
- •Suffer from claustrophobia.
- •Use of tobacco, nicotine, or illegal drugs of abuse.
- •Use of caffeine within two days prior to each study visit.
- •HIV, hepatitis, edema, untreated blood pressure problems, heart, lung, nervous system or kidney disease, history of blood clots in the legs, diabetic neuropathy, or untreated thyroid disease.
- •Use of drugs or medications that affect the levels of fluid in the body, such as diuretics.
结局指标
主要结局
Changes in interstitial fluid volume in the lower extremities as measured by MRI.
次要结局
- Assessments of other indicators of fluid volume changes, including labwork evaluation, fluid compartment volume measurement, direct measurement of the calf.
研究者
研究点 (2)
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