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NCT Number: NCT03014908

Metabolic Profiling of Type 1 Diabetes Mellitus in Children and Adolescents

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.

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Key information

Conditions

Type1diabetes Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

8 year–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Hasselt University

Hasselt, Limburg, 3500, Belgium

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Blood sampling

Other

Determine the metabolic phenotype of blood plasma by proton-NMR spectroscopy

Primary outcomes

  1. Metabolic phenotype of type 1 diabetes mellitus

    Time frame: 10 months

    Significant metabolic changes in blood plasma of type 1 diabetic patients compared with control subjects

Sponsors and collaborators

Lead sponsor

Hasselt University

Other

Collaborators

  • Jessa Hospital

Registry information

Official study title

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

Acronym: T1DM

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Jan 9, 2017
Registry last updated
Jan 9, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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