NCT03014908

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2014

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2014

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

December 12, 2016

Completed
28 days until next milestone

First Posted

Study publicly available on registry

January 9, 2017

Completed
Last Updated

January 9, 2017

Status Verified

January 1, 2017

Enrollment Period

8 months

First QC Date

December 12, 2016

Last Update Submit

January 6, 2017

Conditions

Type1diabetes

Keywords

Type 1 diabetes1H-NMR spectroscopyMetabolomicsPediatrics

Outcome Measures

Primary Outcomes (1)

  • Metabolic phenotype of type 1 diabetes mellitus

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

    10 months

Study Arms (2)

NMR-T1DM

type 1 diabetic children and adolescents

Other: Blood sampling

NMR-C

non-diabetic children and adolescents

Other: Blood sampling

Interventions

Blood samplingOTHER

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

NMR-CNMR-T1DM

Eligibility Criteria

Age8 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability Sample
Study Population

from 7 T1DM children and 7 non-diabetic controls aged 8 to 18 years, and matched for gender, age and BMI

You may qualify if:

  • aged between 8 and 18
  • normal-weight according to the International Obesity Task Force (IOTF) BMI criteria
  • fasted for at least 8 hours.

You may not qualify if:

  • lipid-lowering drugs or other medication

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hasselt University

Hasselt, Limburg, 3500, Belgium

Location

Related 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. doi: 10.1038/nprot.2007.376.

    PMID: 18007604BACKGROUND

  • 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.

    PMID: 26317989BACKGROUND

  • 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.

    PMID: 20479934BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood plasma for proton-NMR spectroscopy

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Peter Adriaensens, PhD

    Institute of Material Research, Hasselt University

    PRINCIPAL INVESTIGATOR

  • Guy Massa, PhD, MD

    Jessa Ziekenhuis Hasselt

    STUDY CHAIR

  • Wanda Guedens, PhD

    Hasselt University

    STUDY CHAIR

  • Evelyne Louis, PhD

    Hasselt University

    STUDY CHAIR

  • Jean-Paul Noben, PhD

    Hasselt University

    STUDY CHAIR

  • Liene Bervoets, PhD

    Hasselt University

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor (hoogleraar)

Study Record Dates

First Submitted

December 12, 2016

First Posted

January 9, 2017

Study Start

January 1, 2014

Primary Completion

September 1, 2014

Study Completion

December 1, 2014

Last Updated

January 9, 2017

Record last verified: 2017-01

Locations

BE(1)