Metabolic Profiling of Type 1 Diabetes Mellitus in Children and Adolescents

NCT ID: NCT03014908

Last Updated: 2017-01-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

14 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-01-31

Study Completion Date

2014-12-31

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.

Conditions

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Type1diabetes

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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NMR-T1DM

type 1 diabetic children and adolescents

Blood sampling

Intervention Type OTHER

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

NMR-C

non-diabetic children and adolescents

Blood sampling

Intervention Type OTHER

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

Interventions

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Blood sampling

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

Intervention Type OTHER

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
Minimum Eligible Age

8 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Jessa Hospital

OTHER

Sponsor Role collaborator

Hasselt University

OTHER

Sponsor Role lead

Responsible Party

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Peter Adriaensens

professor (hoogleraar)

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Peter Adriaensens, PhD

Role: PRINCIPAL_INVESTIGATOR

Institute of Material Research, Hasselt University

Guy Massa, PhD, MD

Role: STUDY_CHAIR

Jessa Ziekenhuis Hasselt

Wanda Guedens, PhD

Role: STUDY_CHAIR

Hasselt University

Evelyne Louis, PhD

Role: STUDY_CHAIR

Hasselt University

Jean-Paul Noben, PhD

Role: STUDY_CHAIR

Hasselt University

Liene Bervoets, PhD

Role: STUDY_CHAIR

Hasselt University

Locations

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Hasselt University

Hasselt, Limburg, Belgium

Site Status

Countries

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Belgium

References

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Beckonert O, Keun HC, Ebbels TM, Bundy J, Holmes E, Lindon JC, Nicholson JK. Metabolic profiling, metabolomic and metabonomic procedures for NMR spectroscopy of urine, plasma, serum and tissue extracts. Nat Protoc. 2007;2(11):2692-703. doi: 10.1038/nprot.2007.376.

Reference Type BACKGROUND
PMID: 18007604 (View on PubMed)

Brugnara L, Mallol R, Ribalta J, Vinaixa M, Murillo S, Casserras T, Guardiola M, Vallve JC, Kalko SG, Correig X, Novials A. Improving Assessment of Lipoprotein Profile in Type 1 Diabetes by 1H NMR Spectroscopy. PLoS One. 2015 Aug 28;10(8):e0136348. doi: 10.1371/journal.pone.0136348. eCollection 2015.

Reference Type BACKGROUND
PMID: 26317989 (View on PubMed)

Lanza IR, Zhang S, Ward LE, Karakelides H, Raftery D, Nair KS. Quantitative metabolomics by H-NMR and LC-MS/MS confirms altered metabolic pathways in diabetes. PLoS One. 2010 May 10;5(5):e10538. doi: 10.1371/journal.pone.0010538.

Reference Type BACKGROUND
PMID: 20479934 (View on PubMed)

Other Identifiers

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LCRP-obesitas

Identifier Type: -

Identifier Source: org_study_id

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