Clinical trial NCT07021326: Phase Angle and TyG Index as Markers of Glycaemic Control, Adiposity and Cardiovascular Risk in T1D Adolescents
Official title: 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.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Type 1 Diabetes Mellitus
Keywords: Adolescent
Metabolic risk
Phase angle
Triglyceride-glucose index
Type 1 diabetes mellitus
Lead sponsor: University of Alicante
Sponsor class: OTHER
First posted: 2025-06-13
Enrollment: 73
Sex: ALL
Minimum age (years): 10
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adolescents aged 10 to 19 years with a diagnosis of type 1 diabetes mellitus, with or without continuous glucose monitoring, who attended a routine clinical visit.

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Patients with type 1 diabetes mellitus (diagnosed).
* Aged between 10 and 20 years.
* With or without a continuous glucose monitor.

Exclusion Criteria:

* Not being hospitalized.
* Not being pregnant, in the case of female patients.

Primary outcomes:
measure: Phase angle
timeFrame: Day 1.
measure: Triglyceride-glucose index (TyG index)
timeFrame: Day 1
Secondary outcomes:
measure: Predictive variable: Fat mass
timeFrame: Day 1.
measure: Predictive variable: Skeletal muscle mass
timeFrame: Day 1.
measure: Predictive variable: Fat free mass
timeFrame: Day 1.
measure: Predictive variable: Lean mass
timeFrame: Day 1.
measure: Predictive variable: Total body water
timeFrame: Day 1.
measure: Predictive variable: Intracellular water
timeFrame: Day 1
measure: Predictive variable: Extracellular water
timeFrame: Day 1
measure: Predictive variables: Biochemical Variables
timeFrame: Day 1
measure: Predictive variable: Weight
timeFrame: Day 1.
measure: Predictive variable: Height
timeFrame: Day 1.
measure: Predictive variable: Body Mass Index (BMI)
timeFrame: Day 1.
measure: Predictive variable: BMI Percentile.
timeFrame: Day 1.
measure: Predictive variable: BMI Z-score
timeFrame: Day 1
measure: Predictive variable: Time in Range (TIR)
timeFrame: Day 1
measure: Predictive variable: Coefficient of Glycaemic Variation (CV)
timeFrame: Day 1
Other outcomes:
Locations:
city: Elche
country: Spain
facility: Hospital General Universitario de Elche
state: Alicante
Study officials:
affiliation: Universidad de Alicante
name: José Miguel Martínez Sanz, PhD
role: PRINCIPAL_INVESTIGATOR
References: