Phase 1, Dose-Dependent Effect of Intranasal Insulin in Humans Using Functional MRI
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- Change in Signal response using fMRI after administration of intranasal insulin
研究概览
简要总结
The purpose of this trial is to study the brain response using functional MRI (fMRI) before and after varying doses of insulin given through the nose. The magnetic resonance imaging uses a very strong magnet to produce images of participant's brain. It becomes a functional MRI when the study team looks at the activity within the brain (blood flow / change in metabolism).
详细描述
If cardiac arrest is not treated immediately, it causes sudden death. Intranasal insulin may be a way to prevent the brain injury that occurs after a cardiac arrest or other brain injury. Even when immediate treatment gets the heart beating again, many victims remain comatose and die later from brain injury. Nasal insulin reduces brain injury in animal experiments and has been used to try to improve brain degeneration in patients with Alzheimer's disease in doses up to 160 units.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- 是
入选标准
- •Participants in good health based on medical history, physical exam, and routine laboratory testing
- •Female participants must have a negative urine pregnancy test or be surgically sterilized or postmenopausal. Criteria for menopause are surgical menopause (hysterectomy, oophorectomy) or age > 45 years with the absence of menses for greater than 12 months.
- •Body mass index (BMI) between 18 kg/m2 and 35 kg/m2
- •Willing and able to stay at the clinical research facility as required by the protocol
- •Willing and able to comply with the investigational nature of the study and able to communicate well with investigators
- •Ability to comprehend and willing to provide written informed consent in accordance with institutional and regulatory guidelines
- •Ability to lie flat for a minimum of 2-hours
排除标准
- •Known allergy to insulin.
- •Preexisting diabetes.
- •Current or previous use of diabetes medication or insulin.
- •Any nasal disease or congestion that may interfere with intranasal drug absorption.
- •Baseline hypoglycemia (blood glucose ≤ 65 milligrams per deciliter (mg/dL)) or hyperglycemia (blood glucose > 200 mg/dL) as evident from the screening labs.
- •Active serious disease, such as liver disease, kidney disease, uncontrolled hypertension, clinically significant hypokalemia, and significant or unstable medical illness
- •Treated with an investigational drug within 30 days.
- •Individuals with inadequate venous access.
- •Claustrophobic, uncontrollable shaking, or unable to lie still for a lengthy period.
- •Any metals or implanted devices within the body.
- •Any foreign metallic objects in the body.
- •Females that are pregnant, trying to become pregnant, or breastfeeding
研究组 & 干预措施
Intranasal insulin and placebo
A total of 3 possible doses will be tested of insulin 0 units (u) (placebo (diluent), 500u, and 1000u. The order that participants will receive these doses will be in a random order.
干预措施: Intranasal insulin (Drug)
结局指标
主要结局
Change in Signal response using fMRI after administration of intranasal insulin
时间窗: Baseline fMRI (approximately 30 minutes), fMRI Approximately 30 minutes (after insulin dose administration)
Values of regions of interest in the fMRI will be calculated for all measures, including cerebral blood flow (CBF), at different used dosages and compared directly as well as with baseline-corrected CBF maps. The study team will determine if a significant difference at different dosages exists.
次要结局
- Change in Blood Glucose (serum or point of care capillary)(Baseline (Immediately before drug administration), up to approximately 90 minutes (after drug dose))
研究者
Florian Schmitzberger
Instructor in Emergency Medicine
University of Michigan