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

January 6, 2017 updated by: Peter Adriaensens, Hasselt University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

14

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Limburg
      • Hasselt, Limburg, Belgium, 3500
        • Hasselt University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

8 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
10 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Collaborators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2014

Primary Completion (Actual)

September 1, 2014

Study Completion (Actual)

December 1, 2014

Study Registration Dates

First Submitted

December 12, 2016

First Submitted That Met QC Criteria

January 6, 2017

First Posted (Estimate)

January 9, 2017

Study Record Updates

Last Update Posted (Estimate)

January 9, 2017

Last Update Submitted That Met QC Criteria

January 6, 2017

Last Verified

January 1, 2017

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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