Beta-Cell - Liver Interactions in Situations of Modified Beta-Cell Function
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age12-16
SponsorPhilippe Klee, MD-PhD
About this trial
The investigators will measure blood levels of 1,5-anhydroglucitol in obese children with or without type 2 diabetes and correlate them with parameters related to functional beta-cell mass and glucose metabolism. The values will be compared to those obtained in healthy volunteers. The aim of the study is to test the validity of 1,5-anhydroglucitol as a novel biomarker of beta-cell mass and function in children with obesity with or without type 2 diabetes.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Children aged 12 to 16 years
Obesity. Defined as a body-mass index above the 97th percentile.
Ability to give informed consent as documented by signature
Disqualifiers
Patients with diabetes mellitus and positive autoantibodies against islets, insulin, islet antigen 2, glutamic acid decarboxylase or Zinc transporter 8.
Patients with known liver disease (other than NAFLD)
Patients treated with an oral antidiabetic drug, glucagon-like peptide-1 analogues or insulin at the time of or less than 2 weeks prior to inclusion.
Patients treated with a drug known to affect liver function
Trial population
50 obese children aged 12 to 16 years who have a normal or altered glucose metabolism.
Trial design
Design model
Case-control
Time perspective
Prospective
Treatments tested in this trial
Measurement of biomarker
Other interventionMeasurement of blood levels of 1,5-anhydroglucitol
Treatment groups
50 Participants
are divided into 1 treatment groupGroup A: Children with obesity1 intervention
Trial outcomes
Primary outcomes
1
Correlation of 1,5-anhydroglucitol levels in obese children with indirect markers of beta-cell function and mass and with metabolic control
Blood levels of 1,5-anhydroglucitol will be correlated with indirect markers of beta-cell function at 2 timepoints
Time frame
First oral glucose tolerance test2
Correlation of 1,5-anhydroglucitol levels in obese children with indirect markers of beta-cell function and mass and with metabolic control
Blood levels of 1,5-anhydroglucitol will be correlated with indirect markers of beta-cell function at 2 timepoints
Time frame
Second oral glucose tolerance test, 2 years after the firstSecondary outcomes
1
Blood levels of 1,5-anhydroglucitol will be correlated with indicators of the liver function at different moments after diagnosis
Blood levels of 1,5-anhydroglucitol will be correlated with indicators of the liver function at 2 timepoints
Time frame
First oral glucose tolerance test2
Blood levels of 1,5-anhydroglucitol will be correlated with indicators of the liver function at different moments after diagnosis
Blood levels of 1,5-anhydroglucitol will be correlated with indicators of the liver function at 2 timepoints
Time frame
Second oral glucose tolerance test, 2 years after the firstSponsors and contacts
Click on the lead sponsor to view all of their trials.
Philippe Klee, MD-PhD
Lead sponsor
University Hospital, Geneva
Sponsor institution
University of Geneva, Switzerland
Collaborator
Source ClinicalTrials.gov