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Phase Angle and TyG Index as Markers of Glycaemic Control, Adiposity and Cardiovascular Risk in T1D Adolescents

U

University of Alicante

Status

Completed

Conditions

Type 1 Diabetes Mellitus

Treatments

Other: there is no intervention

Study type

Observational

Funder types

Other

Identifiers

NCT07021326
PA-TYG-T1DM-ADOLESCENTS-2025

Details and patient eligibility

About

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.

Full 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.

Enrollment

73 patients

Sex

All

Ages

10 to 19 years old

Volunteers

No Healthy Volunteers

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.

Trial design

73 participants in 1 patient group

Unique group: Adolescents with type 1 diabetes mellitus.
Description:
Adolescents with type 1 diabetes mellitus who meet the inclusion criteria and participated in a single assessment involving body composition measurement.
Treatment:
Other: there is no intervention

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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