The Effects of the Selective Serotonin Reuptake Inhibitor, Fluoxetine and/or DHEA, on Neuroendocrine, Autonomic Nervous System and Metabolic Counterregulatory Responses During Repeated Hypoglycemia in T1DM Individuals
试验速览
- 阶段
- 早期 1 期
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Change in the level of catecholamines in plasma
研究概览
简要总结
(1) To determine how the Selective Serotonin Reuptake Inhibitor (SSRI), fluoxetine (Prozac), an antidepressant often used to treat depression, stimulates the participant's body's ability to defend against low blood sugar (hypoglycemia). (2) To learn how a hormone, dehydroepiandrosterone (DHEA), stimulates the participant's body's ability to defend itself from low blood sugar (hypoglycemia). DHEA is a hormone produced naturally in the human body. However, it can be manufactured and is sold as an over-the-counter dietary supplement. The dose the investigators are giving in this study is higher than the usual recommended dosage taken as a supplement for certain medical conditions. (3) To study combined effects of fluoxetine and DHEA during low blood glucose. In the present study, the investigators will measure the participant's body's responses to hypoglycemia when given fluoxetine or DHEA or fluoxetine and DHEA or a placebo (a pill with no fluoxetine or DHEA). Approximately 64 individuals with type 1 diabetes will take part in this study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •64 (32 males, 32 females) T1DM patients aged 18-50 yr.
- •HbA1c < 11.0%
- •No clinically diagnosed diabetic tissue complications (i.e. history of retinopathy, neuropathy, stasis ulcers, etc)
- •Body mass index < 40kg · m-2
排除标准
- •Pregnancy
- •Subjects unable to give voluntary informed consent
- •Subjects on anticoagulant drugs, anemic or with known bleeding diatheses
- •Subjects taking any of the following medications will be excluded: Non-selective Beta Blockers, Sedative-Hypnotics, Anticonvulsants, Antiparkinsonian drugs, Antipsychotics, Antidepressants, Mood stabilizers, CNS Stimulants, Opioids, Hallucinogens
- •Subjects with a recent medical illness or past history of severe depression, mania or psychotic disease
- •Subjects that score greater than 50 on the depression scale
- •Subjects unwillingness or inability to comply with approved contraception measures
- •Abnormal results following screening tests and physical examination that are clinically significant
- •Subjects with a history of severe uncontrolled hypertension (i.e., blood pressure greater than 160/100), heart disease, cerebrovascular incidents
- •Clinically significant cardiac abnormalities (e.g. heart failure, arrhythmias, ischemic tachycardia, S-T segment deviations, etc.) from history or from cardiac stress testing in subjects ≥ 40 years old.
- •Pneumonia
- •Hepatic Failure/Jaundice
- •Creatinine greater than 1.6 mg/dl
- •Acute Cerebrovascular/ Neurological deficit
- •Fever greater than 38 °C
- •Screening Laboratory Tests Exclusion Criteria
- •Hematocrit lower than 32
- •WBC lower than 3 thou/ul or greater than 14 thou/ul
- •Liver Function Tests: SGOT and SGPT greater than twice upper limit of normal range (i.e. greater than 80 U/L).
- •TBil greater than 2 mg/dl
- •Alkaline Phosphatase greater than 150U/L
- •Positive HIV, Hep B, Hep C
- •Hepatic transaminase > 2x normal
研究组 & 干预措施
Placebo 1
Visit 1:
Study Day 1: Hyperinsulinemia/ euglycemia clamp in the AM and PM. Study Day 2: Hyperinsulinemia/ hypoglycemia clamp in the AM only. 8-weeks of treatment with placebo
Visit 2:
same as visit 1
干预措施: Placebo Oral Tablet (Drug)
Placebo 2
Visit 1:
Study Day 1: Hyperinsulinemia/ hypoglycemia clamp in the AM and PM. Study Day 2: Hyperinsulinemia/ hypoglycemia clamp in the AM only. 8-weeks of treatment with placebo
Visit 2:
same as visit 1
干预措施: Placebo Oral Tablet (Drug)
Fluoxetine
Visit 1:
Study Day 1: Hyperinsulinemia/ hypoglycemia clamp in the AM and PM. Study Day 2: Hyperinsulinemia/ hypoglycemia clamp in the AM only. 8-weeks of treatment with fluoxetine
Visit 2:
same as visit 1
干预措施: Fluoxetine (Drug)
DHEA
Visit 1:
Study Day 1: Hyperinsulinemia/ hypoglycemia clamp in the AM and PM. Study Day 2: Hyperinsulinemia/ hypoglycemia clamp in the AM only. 8-weeks of treatment with DHEA
Visit 2:
same as visit 1
干预措施: DHEA (Drug)
Fluoxetine and DHEA
Visit 1:
Study Day 1: Hyperinsulinemia/ hypoglycemia clamp in the AM and PM. Study Day 2: Hyperinsulinemia/ hypoglycemia clamp in the AM only. 8-weeks of treatment with fluoxetine and DHEA
Visit 2:
same as visit 1
干预措施: Fluoxetine and DHEA (Drug)
结局指标
主要结局
Change in the level of catecholamines in plasma
时间窗: An average of 3 years
次要结局
未报告次要终点
研究者
Stephen N. Davis, MBBS
Chairman of Medicine
University of Maryland, Baltimore