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Add-on study of new biomarkers in Type 2 Diabetes Mellitus


- candidate number14948
- NTR NumberNTR4018
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR3-jun-2013
- Secondary IDs131461 PRACLINI
- Public TitleAdd-on study of new biomarkers in Type 2 Diabetes Mellitus
- Scientific TitlePILOT TRIAL IN TYPE 2 DIABETES MELLITUS PATIENTS TO EXPLORE NEW FINGERPRINTS AND FUNCTIONAL MARKERS DURING START AND STOP OF REGULAR PHARMACOLOGICAL GLUCOSE LOWERING TREATMENT AS ADD-ON TO NEW COMPOUND PHASE 1 STUDIES
- ACRONYM
- hypothesisObjectives
Primary: To examine the effects of regular glucose lowering treatment on inflammatory markers in type 2 Diabetes Mellitus Secondary: To identify markers/fingerprints that predict the response of a patient to glucose lowering therapy in type 2 Diabetes Mellitus and To identify fingerprints/markers related to pathogenic mechanisms of type 2 Diabetes Mellitus
- Healt Condition(s) or Problem(s) studiedDiabetes Mellitus Type 2 (DM type II), Metformin, Biomarkers
- Inclusion criteriaDiabetes Mellitus type 2 patients eligible to start wash-out as per criteria in new compound studies
- Exclusion criteriaN/A
- mec approval receivedyes
- multicenter trialno
- randomisedno
- group[default]
- TypeSingle arm
- Studytypeobservational
- planned startdate 16-jul-2013
- planned closingdate1-jan-2016
- Target number of participants30
- InterventionsNon interventional study in which only blood and urine samples will be collected. (add-on procedures on top of new compound phase 1 studies, only for patients).
- Primary outcomeN/A
- Secondary outcomeN/A
- Timepoints4 time points: Fasting blood and urine samples before and after wash-out and before restart and at follow-up of regular glucose lowering medication. Sample timing as per the main study visit schedule. For exploratory markers: samples of blood and urine before and after wash-out period and before and after restart regular glucose lowering medication
- Trial web siteN/A
- statusplanned
- CONTACT FOR PUBLIC QUERIESMD, PhD, R.G. Tiessen
- CONTACT for SCIENTIFIC QUERIESMD, PhD, R.G. Tiessen
- Sponsor/Initiator
- Funding
(Source(s) of Monetary or Material Support)
TNO
- PublicationsN/A
- Brief summaryPILOT TRIAL IN TYPE 2 DIABETES MELLITUS PATIENTS TO EXPLORE NEW FINGERPRINTS AND FUNCTIONAL MARKERS DURING START AND STOP OF REGULAR PHARMACOLOGICAL GLUCOSE LOWERING TREATMENT AS ADD-ON TO NEW COMPOUND PHASE 1 STUDIES Objectives
Primary: To examine the effects of regular glucose lowering treatment on inflammatory markers in type 2 Diabetes Mellitus

Secondary: To identify markers/fingerprints that predict the response of a patient to glucose lowering therapy in type 2 Diabetes Mellitus
To identify fingerprints/markers related to pathogenic mechanisms of type 2 Diabetes Mellitus

Methodology Design:Non interventional study in which only blood and urine samples will be collected. (add-on procedures on top of new compound phase 1 studies, only for patients)

Procedures and assessments
Blood and urine sampling: Fasting blood and urine samples before and after wash-out and before restart and at follow-up of regular glucose lowering medication. Sample timing as per the main study visit schedule. For exploratory markers: samples of blood and urine before and after wash-out period and before and after restart regular glucose lowering medication
Assessments: No assessments. Patient data which is already collected during screening, wash-out and restart periods in a new compound phase 1 study will be used (copy of data)
Bio analysis: Paired (before/after) analysis of samples using an established method. The analyses will include a) a panel of (tissue-specific) functional markers which are determined by ELISA or multiplex analyses to assess the metabolic and inflammatory state of the entire organism as well as of specific organs (tissue-specific functional markers), b) metabolomics/lipidomics (analysis of specific lipids, metabolites, peptides) and c) a targeted analysis of miRNAs associated with cardiometabolic disease.

Diagnosis and main criteria for inclusion
Criteria: Diabetes Mellitus type 2 patients eligible to start wash-out as per criteria in new compound studies
Pathology: Type 2 Diabetes Mellitus
Patients: Patients who are selected to participate in a new compound phase 1 study and who are willing to give their consent for this add-on study (minimum n=30)

Criteria for evaluation
Pharmacodynamics: changes in concentration from baseline of known and exploratory markers of regular glucose lowering medication
Markers: Biomarkers to be used for evaluation of tissue-specific markers of inflammation include:
- Liver-related: Fibrinogen,CRP, SAA, IL-10, specific miRNAs (e.g. miRNA34a), DNA, mRNA, betatrophin
- Adipose tissue related: Adipokines such as leptin, adiponectin, resistin, PAI-1, MCP-1, betatrophin
- Muscle related: Myokines, irisin, branched chain amino acids
- Vasculature/ Endothelial dysfunction : VCAM, ICAM, vWF, E-selectin,
- Pancreas: insulin, C-peptide, glucagon
- Lipid-mediators and metabolites associated with metabolic imbalance and inflammation among which bioactive lipids, phospholipids, amino acids, peptides, carbohydrates, nucleotides, hormones, T1AM, carnitine and derivates, vitamins) . These analytes will be determined (semi-quantitatively) by an established combined lipidomics and metabolomics platform.

Statistical methods
PD parameters: explorative descriptive statistics.
- Main changes (audit trail)
- RECORD3-jun-2013 - 15-jun-2013


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