Physiologic Markers of Cardiometabolic Risk in People With Type 1 Diabetes
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Change in VAT/(VAT+SAT) from baseline to 1 year
研究概览
简要总结
More than 40% of young adults with type 1 diabetes (T1D) also have overweight or obesity. Each of these diagnoses increase the risk of adverse cardiovascular events. Investigators aim to obtain reference data for individuals with T1D who do not have overweight obesity, to understand how close GLP-1 analogue obesity treatment in those with overweight/obesity brings physiologic markers of cardiometabolic risk to those with BMI in the normal range. Specifically, investigators will describe how drivers of gluconeogenesis and lipemia (specifically measured as visceral fat ratio, insulin resistance, and postprandial lipemia,) that contribute to cardiometabolic risk in T1D change over time.
详细描述
Primary Objective
The primary objectives of this physiologic study are to:
- examine how visceral adipose tissue (VAT), measured as VAT/Subcutaneous Adipose Tissue + VAT changes over 1 year in young adults with T1D and body mass index <25kg/m2.
- determine how hepatic insulin resistance changes over 1 year in young adults with T1D and body mass index <25kg/m2.
- determine how the area under the curve of triglycerides after a high fat mixed meal tolerance test changes over 1 year in young adults with T1D and body mass index <25kg/m2.
Secondary Objective
The secondary objective[s] of this study are to determine change in:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 30 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Provision of signed and dated informed consent form
- •Stated willingness to comply with all study procedures and availability for the duration of the study
- •Male or female, aged 18 to ≤30 years
- •Diagnosed T1D for at least 12 months and with BMI <25 kg/m
- •HbA1c ≤10%
- •Clinical use of continuous glucose monitoring (CGM)
- •Any known laboratory safety parameter consistently outside the below extended laboratory ranges in the past year:
- •Baseline creatinine >1.0mg
- •Hypertriglyceridemia (>400 mg/dl)
- •ALT ≥3.5 times the upper normal limit (UNL)
排除标准
- •Current use of adjunctive diabetes medication or anti-obesity medication
- •Insulin dose <0.5 units/kg/day
- •Use of lipid lowering prescription medication other than statins or omega-3 products
- •Doesn't meet MRI safety criteria or having claustrophobia
- •Known liver disease other than non-alcoholic steatosis or non-alcoholic fatty liver disease
- •Known renal impairment
- •Pregnancy or lactation, or planning to become pregnant during the study period.
- •Anemia or known hematologic condition impacting HbA1c reading, or another medical condition that precludes participation.
- •Treatment with another investigational drug within the past 1 month
- •Past medical history of or self-reported corn allergy
研究组 & 干预措施
Young adults with T1D who have a body mass index <25 kg/m2
Young adults with T1D who have a body mass index <25 kg/m2 will have: abdominal MRI, hyperinsulinemic-euglycemic clamp wtih stable isotope tracer, DEXA scan and a High Fat Mixed Meal Tolerance Test.
干预措施: Hyperinsulinemic-euglycemic clamp (Biological)
Young adults with T1D who have a body mass index <25 kg/m2
Young adults with T1D who have a body mass index <25 kg/m2 will have: abdominal MRI, hyperinsulinemic-euglycemic clamp wtih stable isotope tracer, DEXA scan and a High Fat Mixed Meal Tolerance Test.
干预措施: High Fat Mixed Meal Tolerance Test (Other)
结局指标
主要结局
Change in VAT/(VAT+SAT) from baseline to 1 year
时间窗: baseline and 1 year
Measured as VAT/Subcutaneous Adipose Tissue + VAT changes over 1 year in young adults with T1D and body mass index \<25kg/m2.
Change in hepatic insulin resistance from baseline to 1 year
时间窗: baseline and 1 year
Hepatic insulin resistance, measured by beta-hydroxybutyrate (surrogate marker of acetyl-CoA, which regulates gluconeogenesis), changes over 1 year in young adults with T1D and body mass index \<25kg/m2.
Change in triglycerides from baseline to 1 year
时间窗: baseline and 1 year
Change in triglycerides after a high-fat mixed meal tolerance test, expressed as the total Area Under the Curve (AUCTG) over 6 hours from baseline to 1 year.
次要结局
未报告次要终点