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

NCT ID: NCT07021326

Last Updated: 2025-06-13

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 73 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-07-21
• Study Completion Date: 2024-10-22

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.

Conditions

Type 1 Diabetes Mellitus

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Unique group: Adolescents with type 1 diabetes mellitus.

Adolescents with type 1 diabetes mellitus who meet the inclusion criteria and participated in a single assessment involving body composition measurement.

there is no intervention

Intervention Type: OTHER

This is an observational, cross-sectional study with no intervention. Data were collected through a single body composition measurement without any treatment or manipulation. Biochemical, clinical and anthropometric data was collected directly from the patient's clinical records. No intervention was needed.

Interventions

there is no intervention

This is an observational, cross-sectional study with no intervention. Data were collected through a single body composition measurement without any treatment or manipulation. Biochemical, clinical and anthropometric data was collected directly from the patient's clinical records. No intervention was needed.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 10 Years
• Maximum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Alicante

OTHER

Sponsor Role: lead

Responsible Party

Marta Garcia Poblet

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

José Miguel Martínez Sanz, PhD

Role: PRINCIPAL_INVESTIGATOR

Universidad de Alicante

Locations

Hospital General Universitario de Elche

Elche, Alicante, Spain

Countries

Spain

Other Identifiers

PA-TYG-T1DM-ADOLESCENTS-2025

Identifier Type: -

Identifier Source: org_study_id