Metabolic Profiling of Type 1 Diabetes Mellitus in Children and Adolescents

Study Overview
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Brief Summary
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The aim of this study was to look for discriminating variation in the concentrations of small-molecule metabolites in the plasma of T1DM children compared with non-diabetic matched controls using proton nuclear magnetic resonance (1H-NMR)-based metabolomics.

Detailed Description
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Type 1 diabetes mellitus (T1DM) is one of the most common pediatric diseases and its incidence is rising in many countries. Recently, it has been shown that metabolites other than glucose play an important role in insulin deficiency and the development of diabetes. The aim of this study was to look for discriminating variation in the concentrations of small-molecule metabolites in the plasma of T1DM children compared with non-diabetic matched controls using proton nuclear magnetic resonance (1H-NMR)-based metabolomics. This cross-sectional study was set-up to examine the metabolic profile in fasting plasma samples from 7 T1DM children and 7 non-diabetic controls aged 8 to 18 years, and matched for gender, age and BMI. The obtained plasma 1H-NMR spectra were rationally divided into 110 integration regions, representing the metabolic phenotype. These integration regions reflect the relative metabolite concentrations and were used as statistical variables to construct (train) a classification model in discriminating between T1DM patients and controls.

Official Title
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Metabolic Profiling of Type 1 Diabetes Mellitus in Children and Adolescents: a Case-control Study

Conditions
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Type1diabetes

Intervention / Treatment
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* Other: Blood sampling


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: aged between 8 and 18 normal-weight according to the International Obesity Task Force (IOTF) BMI criteria fasted for at least 8 hours. Exclusion Criteria: lipid-lowering drugs or other medication

Ages Eligible for Study
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Minimum Age: 8 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| NMR-T1DM<br>type 1 diabetic children and adolescents | Other: Blood sampling<br>* Determine the metabolic phenotype of blood plasma by proton-NMR spectroscopy<br>|
| NMR-C<br>non-diabetic children and adolescents | Other: Blood sampling<br>* Determine the metabolic phenotype of blood plasma by proton-NMR spectroscopy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Metabolic phenotype of type 1 diabetes mellitus | Significant metabolic changes in blood plasma of type 1 diabetic patients compared with control subjects | 10 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Type 1 diabetes, 1H-NMR spectroscopy, Metabolomics, Pediatrics