Metabolic Profiling of Type 1 Diabetes Mellitus in Children and Adolescents

Completed

• Conditions: Type1diabetes
• Interventions: Other: Blood sampling

• Registration Number: NCT03014908
• Lead Sponsor: Hasselt University

Brief Summary

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

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.

Study Timeline

• Study Start: 2014-01
• Primary Completion: 2014-09
• Study Completion: 2014-12
• Study First Submitted: 2016-12-12
• Status Verified: 2017-01
• Study First Submitted QC: 2017-01-06
• Last Update Submitted: 2017-01-06
• Study First Posted: 2017-01-09
• Last Update Posted: 2017-01-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 14

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
NMR-T1DM	Blood sampling	type 1 diabetic children and adolescents
NMR-C	Blood sampling	non-diabetic children and adolescents

Primary Outcome Measures

Name	Time	Method
Metabolic phenotype of type 1 diabetes mellitus	10 months	Significant metabolic changes in blood plasma of type 1 diabetic patients compared with control subjects

Trial Locations

Locations (1)

Hasselt University; 🇧🇪 Hasselt, Limburg, Belgium