Reducing Hypoglycemic, Pro-coagulant and Pro-atherothrombotic Responses and Preventing Hypoglycemia Associated Autonomic Failure in Type 1 DM. The Effects of Glucagon-like Peptide-1
试验速览
- 阶段
- 早期 1 期
- 状态
- 撤回
- 入组人数
- 40
- 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
The hypotheses to be tested in this application is: GLP-1 will acutely protect arterial endothelial function and reduce pro-atherothrombotic and pro-coagulant effects of repeated hypoglycemia in T1DM.
详细描述
The naturally occurring hormone GLP-1 when co-administered during hypoglycemia (low blood sugar) in non-diabetic individuals can reduce the deleterious effects of hypoglycemia on the vasculature. We have shown that IV infusion of GLP-1 during a single moderate episode of hypoglycemia can preserve endothelial function and protect the vasculature from pro-coagulant and pro-inflammatory effects in healthy individuals.
It is unknown whether GLP-1 could protect the vasculature during episodes of repeated hypoglycemia and whether GLP-1 would have protective effects in T1DM individuals.
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
- Triple (Participant, Care Provider, 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
- •40 (20 males, 20 females) individuals with type 1 diabetes aged 18-50 yr.
- •HbA1c < 11.0%
- •Body mass index < 40kg • m-2
- •No clinically diagnosed diabetic tissue complications (i.e. history of retinopathy, neuropathy, stasis ulcers, etc)
排除标准
- •Subjects unable to give voluntary informed consent
- •Pregnancy
- •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 unwillingness or inability to comply with approved contraception measures
- •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
- •Abnormal results following screening tests and physical examination that are clinically significant
- •Acute cerebrovascular/ neurological deficit
- •Fever greater than 38.0 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. > 80 U/L)
- •TBil > 2 mg/dl
- •Creatinine > 1.6 mg/dl
- •Alkaline phosphatase > 150U/L
- •Hepatic transaminase > 2x normal
研究组 & 干预措施
Placebo 1
The participants will be randomized to placebo infusion.
干预措施: Placebos (Drug)
Placebo 2
The participants will be randomized to placebo infusion.
干预措施: Placebos (Drug)
GLP-1
The participants will be randomized to Glucagon-like peptide-1 infusion.
干预措施: Glucagon-like peptide-1 (Drug)
结局指标
主要结局
Change in the level of catecholamines in plasma
时间窗: 3 years
次要结局
未报告次要终点
研究者
Stephen N. Davis, MBBS
Professor
University of Maryland, Baltimore