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Trial record 40 of 2791 for:    Type 1 Diabetes

Metabolic Profiling of Type 1 Diabetes Mellitus in Children and Adolescents (T1DM)

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ClinicalTrials.gov Identifier: NCT03014908
Recruitment Status : Completed
First Posted : January 9, 2017
Last Update Posted : January 9, 2017
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment
Type1diabetes Other: Blood sampling

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 Design

Study Type : Observational
Actual Enrollment : 14 participants
Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: Metabolic Profiling of Type 1 Diabetes Mellitus in Children and Adolescents: a Case-control Study
Study Start Date : January 2014
Primary Completion Date : September 2014
Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1
U.S. FDA Resources

Groups and Cohorts

Group/Cohort Intervention/treatment
NMR-T1DM
type 1 diabetic children and adolescents
Other: Blood sampling
Determine the metabolic phenotype of blood plasma by proton-NMR spectroscopy
NMR-C
non-diabetic children and adolescents
Other: Blood sampling
Determine the metabolic phenotype of blood plasma by proton-NMR spectroscopy


Outcome Measures

Primary Outcome Measures :
  1. Metabolic phenotype of type 1 diabetes mellitus [ Time Frame: 10 months ]
    Significant metabolic changes in blood plasma of type 1 diabetic patients compared with control subjects


Biospecimen Retention:   Samples Without DNA
Blood plasma for proton-NMR spectroscopy

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   8 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03014908


Locations
Belgium
Hasselt University
Hasselt, Limburg, Belgium, 3500
Sponsors and Collaborators
Hasselt University
Jessa Hospital
Investigators
Principal Investigator: Peter Adriaensens, PhD Institute of Material Research, Hasselt University
Study Chair: 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
More Information

Publications:
Responsible Party: Peter Adriaensens, professor (hoogleraar), Hasselt University
ClinicalTrials.gov Identifier: NCT03014908     History of Changes
Other Study ID Numbers: LCRP-obesitas
First Posted: January 9, 2017    Key Record Dates
Last Update Posted: January 9, 2017
Last Verified: January 2017

Keywords provided by Peter Adriaensens, Hasselt University:
Type 1 diabetes
1H-NMR spectroscopy
Metabolomics
Pediatrics

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases