Regulation of Glutathione Homeostasis in Adolescents With Type 1 Diabetes - Study A
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Glutathione Concentration
研究概览
简要总结
Glutathione is normally present at high (millimolar) levels in blood and plays an important role in the body's defense against oxidative stress, that is, against the damage caused to the body by reactive oxygen species produced by the metabolism of most nutrients, including glucose. Glutathione is a small peptide made from 3 amino acids, glutamate, cysteine, and glycine.
This study is looking at how blood sugar levels may affect the way glutathione is made and used by the body. Since glutathione is continuously synthesized and broken down, the amount of glutathione present in blood depends on the balance between its rate of synthesis and its rate of use.
In earlier studies, the investigators found that in poorly controlled diabetic teenagers, glutathione was low, not because its production was decreased, but because it was used at an excessive rate. In this study, the investigators want to determine how short-term changes in blood sugar levels affect glutathione levels. This will help improve our understanding of how diabetes affects metabolism.
详细描述
Adolescents with uncomplicated T1D will receive two, 5-hour infusions of deuterium-labeled cysteine on 2 separate days, a few weeks apart, while blood glucose will be maintained, using intravenous insulin infusion:
- in the hyper-glycemic range (200-250 mg/dL) on one study day, and
- near normoglycemia (80-140 mg/dL) on the other study day.
The order of the study days will be randomized.
We will determine whether the level of blood glucose at the time of study affects blood glutathione concentration, and, if so, whether this is associated with changes in the fractional rate of glutathione synthesis, as determined from the incorporation of labeled cysteine into blood glutathione over the course of the 5-hr infusion of labeled cysteine.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 14 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 1 diabetes, using usual criteria such as: glycosuria, hyperglycemia prior to treatment
- •BMI <25 kg/m2
- •Age 14-18
- •HbA1c>7.5%
- •No evidence of diabetic complications
- •Written informed consent from parents or legal guardian, and assent from patient
排除标准
- •Presence of significant anemia (hemoglobin <11g/dL)
- •Presence of intercurrent illness such as infection
- •Presence of chronic disease such as other endocrine deficiency, chronic respiratory or cardiac disease
- •Chronic use of medication other than insulin
- •Use of vitamin or mineral supplements within 2 weeks of study
研究组 & 干预措施
Normoglycemia
80-140 mg/dL
干预措施: Cysteine isotope infusion at normoglycemia vs hyperglycemia (Other)
Normoglycemia
80-140 mg/dL
干预措施: Regular Insulin (Drug)
Hyperglycemia
200-250 mg/dL
干预措施: Cysteine isotope infusion at normoglycemia vs hyperglycemia (Other)
Hyperglycemia
200-250 mg/dL
干预措施: Regular Insulin (Drug)
结局指标
主要结局
Glutathione Concentration
时间窗: Up to 30 minutes post- 5 hour infusion on Day 1 (First Intervention) and up to 30 minutes post- 5 hour infusion on Day 14 (Second Intervention)
umol/L
次要结局
未报告次要终点
研究者
Dominique Darmaun
Physician
Nemours Children's Clinic