Mechanisms of Action of Hydroxychloroquine in Reducing Risk of Type 2 Diabetes
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Insulin Sensitivity
研究概览
简要总结
The purpose of this study is to determine the short-term effects of the antimalarial medication, hydroxychloroquine (HCQ), compared with placebo using frequently sampled intravenous glucose tolerance testing (FSIGTT) methodology to study changes in insulin secretion and glucose tolerance in subjects at risk for developing Type 2 diabetes.
详细描述
Diabetes is approaching epidemic proportions in the United States. This study evaluates the mechanisms of action of a generic drug that may have effects on glucose metabolism.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age > or = 18, able to provide informed consent
- •Body-mass index greater than or equal to 25
- •Presence of at least one indicator of insulin resistance from the following list:
- •Family history of Type 2 diabetes (parent, sibling)
- •Fasting glucose 100 - 125 mg/dl
- •Fasting serum insulin greater than or equal to 7uU/ml
- •Personal history of gestational diabetes
- •Negative pregnancy test for women with childbearing potential
排除标准
- •Diagnosis of diabetes mellitus Type 1 or Type 2
- •Active autoimmune disease, chronic infection, current malignancy (excluding basal cell carcinoma), or other active inflammatory state that, in the opinion of the investigators, would affect insulin sensitivity
- •Oral corticosteroid use in prior six months, or expectation of needing corticosteroid therapy in upcoming six months
- •Known allergy or intolerance to HCQ
- •Known glucose-6 phosphate dehydrogenase deficiency
- •Known eye disease associated with retinal pigmentation abnormalities
- •Known diabetic retinopathy requiring past or planned laser therapy
- •Inability to comply with visit schedule and protocol requirements
- •Inability to manage and take medication as instructed
- •Current or planned pregnancy in upcoming 12 months
- •Inability or unwillingness to use reliable method of contraception (for women of childbearing years, men, or men's partners with childbearing potential), such as oral contraceptive pills, barrier method (diaphragm and condom with spermicide), intrauterine device, or depo-provera injections for 3 months prior to enrollment
- •Anemia (HGB < 9)
- •Any history of bariatric (weight loss) surgery
- •Current use of the medication Glucophage (metformin)
- •Weight changes of 6 pounds or more in the past 4 weeks
- •Any other underlying or concomitant condition, which in the opinion of the principal investigator, could confound the results of the study or put the subject at undue risk
研究组 & 干预措施
Placebo
Thirteen weeks of daily placebo following FSIGTT testing
干预措施: Placebo (Other)
hydroxychloroquine
Thirteen weeks of daily hydroxychloroquine following FSIGTT testing
干预措施: hydroxychloroquine (Drug)
结局指标
主要结局
Insulin Sensitivity
时间窗: 13 weeks after baseline measurement
Change from baseline in the insulin sensitivity index (Si)
次要结局
- Beta Cell Function(13 weeks after baseline measurement)
研究者
Frederico Toledo
Principal Investigator
University of Pittsburgh