Type 1 Diabetes Impacts of Semaglutide on Cardiovascular Outcomes
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Change in Ascending Aortic Pulse Wave Velocity (AA PWV)
研究概览
简要总结
This trial plans to learn more about the effects of a medication, semaglutide, on cardiovascular function, kidney function, and insulin sensitivity in adults with type 1 diabetes. This medication has been effective in reducing cardiovascular disease and diabetic kidney disease and improving glucose control and BMI in adults with type 2 diabetes. This study aims to look at how well the medication works in people with type 1 diabetes. Semaglutide is not approved by the FDA to be used in this way. These procedures are considered to be experimental.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 49 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-49 years
- •1) T1D diagnosis defined as positive T1D-associated antibody(ies) or 2) a clinical diagnosis of T1D plus insulin requirement since diagnosis
- •Insulin pump or automated insulin delivery systems
- •Estimated glomerular filtration rate (eGFR) ≥ 45 ml/min/1.73m2
- •Stable doses of drugs altering cardiovascular and renal function (e.g., Angiotensin-Converting Enzyme Inhibitor (ACEi), Angiotensin Receptor Blocker (ARB), statins, diuretics)
- •BMI 20-45 kg/m2
- •Adequate contraceptive method for females
排除标准
- •HbA1c >9%, recent diabetic ketoacidosis (DKA) or hospitalization
- •Major congenital heart disease, anemia, severe non-proliferative retinopathy, proliferative retinopathy
- •History/family history of medullary thyroid carcinoma, multiple endocrine neoplasia type 2 (MEN2), pancreatitis
- •Current/planned pregnancy or nursing
- •Uncontrolled thyroid disease or hypertension (HTN) (≥ 160/100 mm Hg despite optimal therapy)
- •Use of other non-insulin diabetes medications, insulin sensitizing medications, or systemic steroids in past 3 months
- •Use of atypical antipsychotics
- •Significant systemic illness such as cancer
- •Shellfish/iodine allergy (only exclusionary to iohexol clearance procedure)
- •MRI or PAH contraindications (only exclusionary to MRI and PAH procedures), GLP-1RA allergy
研究组 & 干预措施
Semaglutide
Participants will receive 0.25 mg once weekly semaglutide injection for 4 weeks.
Participants will receive 0.50 mg once weekly semaglutide injection for 4 weeks.
Participants will receive 1.0 mg once weekly semaglutide injection for 6 months.
干预措施: Semaglutide Pen Injector (Drug)
Placebo
Participants will receive 0.25 mg once weekly placebo injection for 4 weeks. Participants will receive 0.50 mg once weekly placebo injection for 4 weeks. Participants will receive 1.0 mg once weekly placebo injection for 6 months.
干预措施: Placebo (Drug)
结局指标
主要结局
Change in Ascending Aortic Pulse Wave Velocity (AA PWV)
时间窗: Baseline, month 8
AA PWV is a measure of central arterial stiffness. A lower value indicates a better outcome.
Change in Carotid and Femoral Artery Pulse Wave Velocity (CF-PWV)
时间窗: Baseline, month 8
CF-PWV is a measure of peripheral arterial stiffness. A lower value indicates a better outcome.
Change in Carotid and Radial Artery Pulse Wave Velocity (CR-PWV)
时间窗: Baseline, month 8
CR-PWV is a measure of peripheral arterial stiffness. A lower value indicates a better outcome.
次要结局
- Change in Renal Vascular Resistance (RVR)(Baseline, month 8)
- Change in Insulin Sensitivity(Baseline, month 8)