Phase Angle and Triglyceride-glucose Index as Glycaemic Control, Body Composition and Cardiovascular Risk Biomarkers in Adolescents With Type 1 Diabetes: a Cross-sectional Study.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 73
- 试验地点
- 1
- 主要终点
- Phase angle
研究概览
简要总结
This study aimed to identify new clinical biomarkers that may improve the follow-up and health outcomes of adolescents with type 1 diabetes. The current clinical practice includes a standard set of measurements for monitoring glycemic control and general health. However, other parameters such as phase angle (obtained through a fast, simple, and painless body composition analysis) might also provide valuable insight into the metabolic status of these patients.
This is a cross-sectional observational study that involved a one-time data collection process. Participants underwent a single body composition measurement (10 seconds, using a bioimpedance analyzer). No interventions or follow-up visits were required.
Additional data was extracted from medical records, including clinical information (e.g., age of diabetes onset, HbA1c, anthropometrics) and results from recent blood tests.
The goal is to determine whether indicators such as the phase angle and triglyceride-glucose (TyG) index could serve as non-invasive tools to assess glycemic control, glycaemic control and cardiovascular risk in adolescents with type 1 diabetes.
The study was conducted at two hospitals from Alicante (Spain) and included patients with a confirmed diagnosis of type 1 diabetes who met the inclusion criteria. Participation was entirely voluntary with informed consent obtained from legal guardians. All collected data were anonymized to prevent reidentification and unauthorized access.
This research seeks to expand scientific knowledge on diabetes management and support the development of more precise, individualized monitoring tools for young people living with type 1 diabetes.
详细描述
This cross-sectional study was conducted in the General Hospital of Elche and the San Juan Hospital (Alicante, Spain).
The assessment of glycemic control was conducted through the analysis of variables derived from continuous glucose monitoring (CGM), specifically focusing on metrics such as time in range (TIR) and the coefficient of glucose variability (CV), which provide detailed insights into glucose fluctuations and stability over time. Additionally, glycated hemoglobin (HbA1c) was taken into account and measured directly during the medical appointment using the Alere Afinion AS100 Analyzer (Abbott, Illinois, United States) device. Body composition was evaluated using a bioelectrical impedance device (Biody-Xpert) and cardiovascular risk was estimated by calculating established indices based on biochemical markers, including the triglyceride to high-density lipoprotein cholesterol (TG/HDL) ratio, as well as anthropometric and body composition-derived indices, such as the fat mass index (FMI), defined as fat mass normalized to height squared (kg/m²).
These multidimensional approaches allowed for a comprehensive evaluation of metabolic control, body composition and cardiovascular risk factors in adolescents with type 1 diabetes, facilitating the exploration of phase angle and the triglyceride-glucose (TyG) index as potential non-invasive biomarkers.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 10 Years 至 19 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with type 1 diabetes mellitus (diagnosed).
- •Aged between 10 and 20 years.
- •With or without a continuous glucose monitor.
排除标准
- •Not being hospitalized.
- •Not being pregnant, in the case of female patients.
结局指标
主要结局
Phase angle
时间窗: Day 1.
Measurement of the phase angle using bioelectrical impedance analysis to assess body composition and cellular health in adolescents with type 1 diabetes by using the portable device Biody-Xpert (Aminogram SAS, La Ciotat, France).
Triglyceride-glucose index (TyG index)
时间窗: Day 1
Calculation of the TyG index from recent fasting blood samples to evaluate insulin resistance and glycaemic control. The TyG index was calculated as Ln\[fasting triglycerides (mg/dl) x fasting glucose (mg/dl)/2\].
次要结局
- Predictive variable: Weight(Day 1.)
- Predictive variable: Fat mass(Day 1.)
- Predictive variable: Skeletal muscle mass(Day 1.)
- Predictive variable: Fat free mass(Day 1.)
- Predictive variable: Lean mass(Day 1.)
- Predictive variable: Total body water(Day 1.)
- Predictive variable: Extracellular water(Day 1)
- Predictive variable: Intracellular water(Day 1)
- Predictive variables: Biochemical Variables(Day 1)
- Predictive variable: Height(Day 1.)
- Predictive variable: Body Mass Index (BMI)(Day 1.)
- Predictive variable: BMI Percentile.(Day 1.)
- Predictive variable: BMI Z-score(Day 1)
- Predictive variable: Time in Range (TIR)(Day 1)
- Predictive variable: Coefficient of Glycaemic Variation (CV)(Day 1)
研究者
Marta Garcia Poblet
Principal Investigator
University of Alicante