Metabolic Profiling of Type 1 Diabetes Mellitus in Children and Adolescents

Type1diabetes Clinical Trial

— T1DM  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03014908
• Other study ID #: LCRP-obesitas
• Status: Completed
• Phase: N/A
• First received: December 12, 2016
• Last updated: January 6, 2017
• Start date: January 2014
• Est. completion date: December 2014

Study information

• Verified date: January 2017
• Source: Hasselt University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Comité voor Medische Ethiek UHasselt
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: December 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 8 Years to 18 Years

Eligibility

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

Observational Model: Case Control, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Type1diabetes

Intervention

Other:
• Blood sampling
Determine the metabolic phenotype of blood plasma by proton-NMR spectroscopy

Locations

Country	Name	City	State
Belgium	Hasselt University	Hasselt	Limburg

Sponsors (2)

Lead Sponsor	Collaborator
Hasselt University	Jessa Hospital

Country where clinical trial is conducted

Belgium, 

References & Publications (3)

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. — View Citation

Brugnara L, Mallol R, Ribalta J, Vinaixa M, Murillo S, Casserras T, Guardiola M, Vallvé 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Metabolic phenotype of type 1 diabetes mellitus	Significant metabolic changes in blood plasma of type 1 diabetic patients compared with control subjects	10 months	No