NCT05179954招募中不适用
Apolipoprotein C3-loading of Apolipoprotein B100 Lipoproteins and Cardiovascular Disease in Patients With Type 1 Diabetes
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Apolipoprotein C turnover rate
研究概览
简要总结
The purpose of this research study is to understand how type 1 diabetes (T1D) increases the risk for cardiovascular diseases (heart attack and stroke). To this end, the investigators will compare apolipoprotein and triglyceride kinetics in people wtih T1D and healthy control participants.
详细描述
Not required
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age: ≥18 but ≤45 years
- •premenopausal/eumenorrheic and not pregnant or breastfeeding
- •non-obese (body mass index ≥18.5<30.0 kg/m2)
- •Fasting plasma triglyceride <150 mg/dL
- •Additional inclusion criteria for control subjects:
- •Fasting plasma glucose <100 mg/dL
- •Plasma glucose 2 h after a 75 g oral glucose challenge <140 mg/dL
- •HbA1c <5.6%.
- •Additional inclusion criteria for subjects with T1DM:
- •stable insulin regimen (multiple daily insulin injections or continuous subcutaneous insulin) for at least 8 weeks before screening
- •no use of diabetes medications other than insulin
- •HbA1c <8.0%, basal (overnight fasted)
- •no severe symptomatic hypoglycemic event associated with a seizure or requiring help from other people or a medical facility in the 6 months prior to screening or metabolic testing
排除标准
- •more than 1.5 h of structured exercise/week
- •use of tobacco products, excessive amounts of alcohol, or dietary supplements and/or medications known to affect lipid metabolism
- •hypothyroidism or other disorders known to affect lipid metabolism
- •conditions that would make it impossible to complete the study protocol
研究组 & 干预措施
Control group
Other
Healthy control group
干预措施: Metabolic testing (Other)
T1D group
Active Comparator
T1D group
干预措施: Metabolic testing (Other)
结局指标
主要结局
Apolipoprotein C turnover rate
时间窗: one time, at baseline (this is a cross-sectional, observational study, no intervention)
Apolipoprotein C turnover rate will be assessed by using an intravenous stable isotope labeled amino acid infusion
次要结局
- Triglyceride turnover rate(one time, at baseline (this is a cross-sectional, observational study, no intervention))
- Apolipoprotein B-100 turnover rate(one time, at baseline (this is a cross-sectional, observational study, no intervention))
- Apolipoprotein C concentration(one time, at baseline (this is a cross-sectional, observational study, no intervention))
- Triglyceride concentration(one time, at baseline (this is a cross-sectional, observational study, no intervention))
- Apolipoprotein B-100 concentration(one time, at baseline (this is a cross-sectional, observational study, no intervention))
研究者
Bettina Mittendorfer
Senior Associate Dean for Research
University of Missouri-Columbia
研究点 (1)
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