An interventional study of oral glucose load and exercise test in Diabetes Mellitus, Short Stature and Glycogen Deposition, sponsored by University of Lausanne. Completed at 2 sites in Switzerland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-05-08.
Sponsored by University of Lausanne · Not applicable, Interventional, and Other
Mauriac syndrome (MS) is an entity of individuals combining poorly controlled diabetes mellitus type 1, short stature and glycogenic hepatopathy. Thus, the functional significance of Mauriac syndrome for glucose metabolism remains disputed, and whether genetic defects in glycogen metabolism contribute to glycogenic hepatopathy in MS remains to be clarified.Coupling the genetic analysis of targeted genes involved in glucose regulation with a dynamic exploration will eventually determine if a genetic abnormality leads to the disease and explains the nature of the phenotype.
Investigation of glucose homeostasis in MS, after an oral glucose load followed by exercise, using a quantitative measurement of the substrate flux. This dynamic in vivo kinetics can be explored using stable, nonradioactive tracers with the help of gas or liquid chromatography.
Investigation of genetic factors associated with MS phenotype. Molecular analysis will be performed by next generation sequencing (exome or whole genome sequencing). In addition, a targeted analysis for pathogenic variants in genes implicated in homeostasis regulation will be done.
8,290 studies on the registry are indexed under Diabetes Mellitus; 1,077 are open to participants now.
This study's enrollment of 6 is below the median of 80 across 6,023 interventional studies indexed under Diabetes Mellitus.
Browse Diabetes Mellitus studies →University of Lausanne is the lead sponsor of 55 studies on the registry; 6 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria:
Inclusion criteria for subjects:
Exclusion criteria for subjects and controls :
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
An oral dose of glucose (labelled with 1% U-13C6-glucose) will be given at time 0 min followed by a 30-min cycling exercise at time 300 min.
Other: oral glucose load · Other: exercise test
An oral dose of glucose (labelled with 1% U-13C6-glucose) will be given at time 0 min followed by a 30-min cycling exercise at time 300 min.
Other: oral glucose load · Other: exercise test
oral glucose load (60g) followed by exercise at fixed wattage (60W) for 30 min
oral glucose load (60g) followed by exercise at fixed wattage (60W) for 30 min
In vivo kinetics of ingested glucose
Plasma glucose kinetics \[Time -90 min before ingestion of a test meal to Time 360 min after ingestion of a test meal\] * Baseline : \[Time -90min to Time 0min\] * After an oral glucose load (60g): \[Time 0min to Time 300min\] * During exercise at fixed wattage (60W) for 30 min: \[Time 300 min to Time 330 min\] * After exercise for 30 min \[Time 330 min to Time 360 min\] Trial stable isotope tracers (\[U-13C6\] glucose ingestion, will be used to assess ingested glucose flux at baseline and during the test.
Time frame: Time -90 minutes to Time 360 minutes
In vivo kinetics of endogenous glucose
Plasma glucose kinetics \[Time -90 min before ingestion of a test meal to Time 360 min after ingestion of a test meal\] * Baseline : \[Time -90min to Time 0min\] * After an oral glucose load (60g): \[Time 0min to Time 300min\] * During exercise at fixed wattage (60W) for 30 min: \[Time 300 min to Time 330 min\] * After exercise for 30 min \[Time 330 min to Time 360 min\] Trial stable isotope tracers \[6,6-2H2\] glucose infusion will be used to assess endogenous glucose flux at baseline and during the test.
Time frame: Time -90 minutes to Time 360 minutes
In vivo kinetics of lactate
Plasma lactate kinetics \[Time -90 min before ingestion of a test meal to Time 360 min after ingestion of a test meal\] * Baseline : \[Time -90min to Time 0min\] * After an oral glucose load (60g): \[Time 0min to Time 300min\] * During exercise at fixed wattage (60W) for 30 min: \[Time 300 min to Time 330 min\] * After exercise for 30 min \[Time 330 min to Time 360 min\] Trial stable isotope tracers \[1-13C1\]lactate infusion will be used to assess lactate flux at baseline and during the test.
Time frame: Time -90 minutes to Time 360 minutes
DNA Banking
10 ml of whole blood will be collected, at baseline, in two tubes EDTA 5ml for DNA extraction and banking in view of next generation sequencing (NGS) analysis.
Time frame: At inclusion period
Ran from Jan 2022 to primary completion in Jul 2022, 6 months.
Of 1,583 non-industry interventional studies with no phase under Diabetes Mellitus, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 43. This study's 6 months is below that.
Counting every sponsor, half of 1,743 studies reached it within 21 months; a quarter within 9 and three quarters within 42.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in May 2024. You cannot join it, but the record below documents what was studied.
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University of Lausanne