An interventional study of LPS in Ketoacidosis and Diabetes Mellitus Type 1, sponsored by University of Aarhus. Completed at 1 site in Denmark. Open to male participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2015-12-02.
Sponsored by University of Aarhus · Not applicable, Interventional, and Basic science
Hypothesis
The investigators plan to reduce in their regular insulin over night. In the morning we administer endotoxin, which together with a relative lack of insulin will initiate ketogenesis - a state of ketoacidosis. On another occasion strict glycemic control is imposed by means of intravenous insulin. The testing is done two separate days with at least 3 weeks in between and patients are admitted to hospital the evening before the day of testing. The investigators use isotopic tracers to determine metabolic fluxes and analyse fat (ATGL, G0/G1 switch gene) and muscle biopsies.
181 studies on the registry are indexed under Ketosis; 37 are open to participants now.
This study's enrollment of 9 is below the median of 25 across 144 interventional studies indexed under Ketosis.
Browse Ketosis studies →University of Aarhus is the lead sponsor of 1,274 studies on the registry; 183 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Insulin reduction and mimic infection with LPS
Biological: LPS
Normal insulin and no LPS
LPS is endotoxin from gram negative bacteria. It is used scientifically to mimic infection lasting 4-8 hours.
Insulin signaling expressed as a CHANGE in phosphorylation of intracellular target proteins and CHANGE in mRNA expression of target genes in muscle- and fat-tissue.
Change in phosphorylation of target proteins and messenger RNA (mRNA) expression of target genes assessed with western blotting technique.
Time frame: Muscle and fat biopsies obtained on each study day (arm): t1= 6.45 (-75min) am t2=11.15 (195min) am t3= 12.30 pm (270min)
Change in Intracellular markers of lipid metabolism in muscle- and fat tissue biopsies
Muscle and fat at t1 and t2. Muscle biopsy at t3. Intracellular markers are assessed by western blotting.
Time frame: Muscle and fat biopsies obtained on each study day (arm): t1= 6.45 am (-75min) t2=11.15 (195min) am t3= 12.30 pm (270min)
Metabolism
Change in glucose, fat and protein metabolism assessed by tracer kinetics on every study day (specific times below) and by indirect calorimetry. \[3H 3\]Glucose tracer from t=0 - 360min. Palmitic acid tracer from t=165min - 360min. Urea tracer from 0min - 240min. amino acid tracer from 60 min - 360 min.
Time frame: Change in glucose, fat and protein metabolism between study days and during each study day
Cytokines and stress hormones
Measurement of immune response to endotoxin and hypoinsulinaemia. Estimating the whole body stress during ketoacidosis and pre ketoacidosis.
Time frame: In basal period t=0-240 minutes and in clamp period t=240-390 minutes
This study is completed, as verified in Jun 2014. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
University of Aarhus