The Association Between Glycemic Metrics and Cardiovascular Markers in Patients With Type 1 Diabetes.
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- E score
研究概览
简要总结
In this cross-sectioanl study, 90 patients aged >12 years old with T1DM who are on MiniMed 780G system will be included.The investigators aim to assesse the association of patients' adherence to Mediterranean diet (MD) with CGM and insulin metrics, as well as anthropometric measurements, BMI, lipid levels and blood pressure.Moreover, markers of endothelial, cardiovascular and liver function will be also assessed and associated with the use of Minimed 780G and the adherence to MD.
详细描述
This cross-sectional study will include 90 participants, children adolescents and young adults (12> years old) with T1D that are on MiniMed 780G system. Participants will be evaluated for adherence to Meditteranean Diet (MD) with PREDIMED questionnaire. HbA1c, CGM and Insulin Metrics, anthropometric measurements, blood pressure and lipid leves will be aso evalutaed. Markers of endothelial cardiovascular and liver function will also be assessed.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 12 Years 至 80 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of type 1 diabetes >1 year prior to consent date. Diagnosis of type 1 diabetes is based on the investigator's judgment; C peptide level and antibody determinations are not required.
- •HbA1c < 12.5%
- •Age >7years at the initiation of the system
- •Patients with Minimed 780G
- •History of 3 clinic visits in the last year
排除标准
- •Diabetic Ketoacidosis in the 6 months prior to screening visits
研究组 & 干预措施
Type 1 Diabetes Mellitus
patients aged >12 years old with T1DM who are on MiniMed 780G
干预措施: Minimed 780G (Device)
结局指标
主要结局
E score
时间窗: Baseline
Assessement of E score and CAP score.
Assessment of CAP score
时间窗: Baseline
CAP score
MED diet
时间窗: Baseline
Assesment of Adherence to MED diet
Fat mass
时间窗: Baseline
Assessment of fat mass
Lean Mass
时间窗: Baseline
Assessment of lean mass
Time in Range
时间窗: Baseline
Assessment of time in range
Time below range
时间窗: Baseline
Assessment of time below range
Time above range
时间窗: Baseline
Assessment of time above range
Basal Insulin dose
时间窗: Baseline
Assessment of basal insulin doses
Correction Insulin dose
时间窗: Baseline
Assessment of correction insulin dose
Pulse wave velocity
时间窗: Baseline
Assessment of pulse wave velocity
Endothelial glycocalyx
时间窗: Baseline
Assessemnet of the thickness of endothelial glycocalyx
Global longitudinal strain
时间窗: Baseline
Assessment of global longitudinal strain.
次要结局
未报告次要终点
研究者
VAIA LAMBADIARI
Professor of Internal Medicine-Endocrinology
Attikon Hospital