Clinical trial NCT03014908: Metabolic Profiling of Type 1 Diabetes Mellitus in Children and Adolescents
Official title: Metabolic Profiling of Type 1 Diabetes Mellitus in Children and Adolescents: a Case-control Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Type1diabetes
Keywords: Type 1 diabetes
1H-NMR spectroscopy
Metabolomics
Pediatrics
Lead sponsor: Hasselt University
Sponsor class: OTHER
Collaborators: name: Jessa Hospital
First posted: 2017-01-09
Enrollment: 14
Sex: ALL
Minimum age (years): 8
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: from 7 T1DM children and 7 non-diabetic controls aged 8 to 18 years, and matched for gender, age and BMI

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.

Eligibility criteria: 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

Primary outcomes:
measure: Metabolic phenotype of type 1 diabetes mellitus
timeFrame: 10 months
Secondary outcomes:
Other outcomes:
Locations:
city: Hasselt
country: Belgium
facility: Hasselt University
state: Limburg
Study officials:
affiliation: Institute of Material Research, Hasselt University
name: Peter Adriaensens, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Jessa Ziekenhuis Hasselt
name: Guy Massa, PhD, MD
role: STUDY_CHAIR
affiliation: Hasselt University
name: Wanda Guedens, PhD
role: STUDY_CHAIR
affiliation: Hasselt University
name: Evelyne Louis, PhD
role: STUDY_CHAIR
affiliation: Hasselt University
name: Jean-Paul Noben, PhD
role: STUDY_CHAIR
affiliation: Hasselt University
name: Liene Bervoets, PhD
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.