- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03014908
Metabolic Profiling of Type 1 Diabetes Mellitus in Children and Adolescents (T1DM)
Metabolic Profiling of Type 1 Diabetes Mellitus in Children and Adolescents: a Case-control Study
Study Overview
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
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Limburg
-
Hasselt, Limburg, Belgium, 3500
- Hasselt University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
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
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
Sponsor
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
General Publications
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- LCRP-obesitas
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