Type 1 Diabetes MellitusNCT07021326
Phase Angle and TyG Index as Markers of Glycaemic Control, Adiposity and Cardiovascular Risk in T1D Adolescents
An observational study of Type 1 Diabetes Mellitus, run by University of Alicante at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 10 to 19 years
- Conditions the study is for
- Type 1 Diabetes Mellitus
- How many people
- 73 participants
- Where
- 1 siteSpain
- Study dates
- 21 Jul 2022to 22 Oct 2024
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 19 years
- All sexes
- No healthy volunteers
- Child, Adult
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.
Who may be able to join
- Patients with type 1 diabetes mellitus (diagnosed).
- Aged between 10 and 20 years.
- With or without a continuous glucose monitor.
Who cannot join
- Not being hospitalized.
- Not being pregnant, in the case of female patients.
Trial locations and contacts
1 site in 1 country.
About this study
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.
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.
Read more
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.
Read the 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
- Being tested
- there is no intervention
- Keywords
- Adolescent, Metabolic risk, Phase angle, Triglyceride-glucose index, Type 1 diabetes mellitus
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
there is no interventionOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: there is no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase angle
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).
Measured: Day 1.
Triglyceride-glucose index (TyG index)
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].
Measured: Day 1
Secondary outcomes (15)
Predictive variable: Fat mass
Includes body fat mass (total amount of fat tissue in the body) in two measurements: % and Kg. These variables were measured using a bioelectrical impedance device and analyzed for their correlation with primary outcomes (phase angle and TyG index).
Measured: Day 1.
Predictive variable: Skeletal muscle mass
Includes skeletal muscle mass (mass of muscles attached to bones for movement) in two measurements: % and Kg. These variables were measured using a bioelectrical impedance device and analyzed for their correlation with primary outcomes (phase angle and TyG index).
Measured: Day 1.
Predictive variable: Fat free mass
Includes body fat-free mass (total body mass excluding all fat tissue) in two measurements: % and Kg. These variables were measured using a bioelectrical impedance device and analyzed for their correlation with primary outcomes (phase angle and TyG index).
Measured: Day 1.
Predictive variable: Lean mass
Includes lean body mass (all non-fat components, including muscles and organs) in two measurements: % and Kg. These variables were measured using a bioelectrical impedance device and analyzed for their correlation with primary outcomes (phase angle and TyG index).
Measured: Day 1.
Predictive variable: Total body water
Total body water (total amount of water in the body) was assessed in liters (L) using a bioelectrical impedance device and analyzed for its correlation with the primary outcomes: phase angle and TyG index.
Measured: Day 1.
Predictive variable: Intracellular water
Intracellular water (water contained within cells) was assessed inn liters (L) using a bioelectrical impedance device and analyzed for its correlation with the primary outcomes: phase angle and TyG index
Measured: Day 1
Predictive variable: Extracellular water
Extracellular water (water found outside cells, including plasma and interstitial fluid) was assessed in liters (L) using a bioelectrical impedance device and analyzed for its correlation with the primary outcomes: phase angle and TyG index
Measured: Day 1
Predictive variables: Biochemical Variables
Includes HbA1c, total cholesterol, HDL cholesterol, LDL cholesterol, triglycerides and fasting blood glucose. These values were obtained from the participant's most recent clinical laboratory results and analyzed for correlation with the primary outcomes (phase angle and TyG index).
Measured: Day 1
Predictive variable: Weight
Wight (body mass measured in kilograms (kg)) was measured using a Seca brand scale.
Measured: Day 1.
Predictive variable: Height
Height (body length measured in centimeters (cm)) was measured using a Seca brand scale.
Measured: Day 1.
Predictive variable: Body Mass Index (BMI)
Body mass index (BMI) was calculated as weight (kg) divided by height squared (m²) and serves as an indicator of body fatness. This measurement was obtained at the study visit and analyzed as a potential predictor of the primary outcomes (phase angle and TyG index).
Measured: Day 1.
Predictive variable: BMI Percentile.
Relative position of BMI compared to a reference population, expressed as a percentile (%). This measurement was obtained at the study visit and analyzed as a potential predictor of the primary outcomes (phase angle and TyG index).
Measured: Day 1.
Predictive variable: BMI Z-score
Standard deviation score indicating how far BMI deviates from the population mean. This measurement was obtained at the study visit and analyzed as a potential predictor of the primary outcomes (phase angle and TyG index).
Measured: Day 1
Predictive variable: Time in Range (TIR)
Average percentage of time blood glucose levels remained within the target range over the past 3 months. This measurement was obtained at the study visit and analyzed as a potential predictor of the primary outcomes (phase angle and TyG index).
Measured: Day 1
Predictive variable: Coefficient of Glycaemic Variation (CV)
Average measure of fluctuations in blood glucose levels over the past 3 months. This measurement was obtained at the study visit and analyzed as a potential predictor of the primary outcomes (phase angle and TyG index).
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2025
- Study start21 Jul 2022
- Primary completion22 Oct 2024
- Study completion22 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type 1 Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 73 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- University of Alicante
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marta Garcia Poblet, University of Alicante
- Investigators
- José Miguel Martínez Sanz, PhD, Principal investigator, Universidad de Alicante
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07021326
- Sponsor's protocol ID
- PA-TYG-T1DM-ADOLESCENTS-2025
- Status last verified
- May 2025
- First submitted
- 25 May 2025
- Last updated
- 13 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Garcia-Poblet M, Martinez-Sanz JM, Alberola-Chazarra MA, Soler-Climent E, Nso-Roca AP, Sospedra I. Phase angle and triglyceride-glucose index as biomarkers of glycemic control, body composition and cardiovascular risk in adolescents with type 1 diabetes: a cross-sectional study. J Endocrinol Invest. 2026 Jun 29. doi: 10.1007/s40618-026-02969-2. Online ahead of print.
PubMed 42371339
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT07021326
- Acronym / sponsor ID
- PA-TYG-T1DM-ADOLESCENTS-2025
- Conditions
- Type 1 Diabetes Mellitus
- Keywords
- Adolescent, Metabolic risk, Phase angle, Triglyceride-glucose index, Type 1 diabetes mellitus
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 73 participants (actual)
- Lead sponsor
- University of AlicanteUniversity, hospital or other
- Study start
- 21 Jul 2022 (actual)
- Primary completion
- 22 Oct 2024 (actual)
- Study completion
- 22 Oct 2024 (actual)
- First posted
- 13 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Unique group: Adolescents with type 1 diabetes mellitus. | – | Other: there is no interventionAdolescents with type 1 diabetes mellitus who meet the inclusion criteria and participated in a single assessment involving body composition measurement. |
Who may qualify
- Ages
- 10 to 19 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (3 listed)
- Patients with type 1 diabetes mellitus (diagnosed).
- Aged between 10 and 20 years.
- With or without a continuous glucose monitor.
Key exclusion criteria (2 listed)
- Not being hospitalized.
- Not being pregnant, in the case of female patients.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| there is no interventionThis 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. | Other | Unique group: Adolescents with type 1 diabetes mellitus. |
Primary outcome
Phase angle
Time frame: 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)
Time frame: 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].
15 secondary outcomes
Predictive variable: Fat mass
Time frame: Day 1.
Predictive variable: Skeletal muscle mass
Time frame: Day 1.
Predictive variable: Fat free mass
Time frame: Day 1.
Predictive variable: Lean mass
Time frame: Day 1.
Predictive variable: Total body water
Time frame: Day 1.
Predictive variable: Intracellular water
Time frame: Day 1
Predictive variable: Extracellular water
Time frame: Day 1
Predictive variables: Biochemical Variables
Time frame: Day 1
Predictive variable: Weight
Time frame: Day 1.
Predictive variable: Height
Time frame: Day 1.
Predictive variable: Body Mass Index (BMI)
Time frame: Day 1.
Predictive variable: BMI Percentile.
Time frame: Day 1.
Predictive variable: BMI Z-score
Time frame: Day 1
Predictive variable: Time in Range (TIR)
Time frame: Day 1
Predictive variable: Coefficient of Glycaemic Variation (CV)
Time frame: Day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2025.
- Derived from this study: PubMed 42371339Garcia-Poblet M, Martinez-Sanz JM, Alberola-Chazarra MA, Soler-Climent E, Nso-Roca AP, Sospedra I. Phase angle and triglyceride-glucose index as biomarkers of glycemic control, body composition and cardiovascular risk in adolescents with type 1 diabetes: a cross-sectional study. J Endocrinol Invest. 2026 Jun 29. doi: 10.1007/s40618-026-02969-2. Online ahead of print.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
José Miguel Martínez Sanz, PhD principal investigator
Universidad de Alicante
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Type 1 Diabetes Mellitus, run by University of Alicante at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Phase angle (time frame: Day 1.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07021326, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jun 2025.