An interventional study of 400 mL Fresubin Energy Drink and 100 mL heavy cream with the addition of the 18F-FTHA radiotracer in Postprandial Lipid Metabolism and Type 1 Diabetes (T1D), sponsored by University of Aarhus. Not yet recruiting at 1 site in Denmark. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-09-26.
Sponsored by University of Aarhus · Not applicable, Interventional, and Basic science
The aim of the proposed study is to investigate the metabolic consequences of varying the timing of meal insulin boluses and skipping boluses altogether in individuals with type 1 diabetes.
The investigator hypothesize that delaying or skipping meal insulin boluses leads to greater ectopic fat storage due to a delayed stimulation of lipoprotein activity and delayed suppression of lipolysis and VLDL-TG secretion.
The study will be carried out as a randomized cross-over clinical investigational trial. The investigators will include 10 individuals with type 1 diabetes. The subjects will be invited for four visits in total: one screening visit and three test days separated by a one-week washout period. At the test days, subjects will consume a liquid mixed meal and: 1) take a meal bolus of insulin 20 min before consuming a liquid mixed meal or 2) take a meal bolus of insulin 20 min after the meal or 3) skip the meal bolus of insulin.
The investigators will apply the 18F-FTHA meal fat tracer method to the liquid mixed meal to determine whole-body organ-specific meal fat storage.
The volunteers will arrive fasted (8 hours) at the Department of Nuclear Medicine \& PET-Centre at 9.00 a.m. Upon arrival, participants will be placed in a bed and have an arterial catheter placed for arterial blood sampling collected at baseline and during the entire trial day. Approximately one hour after arriving, participants will consume a liquid mixed meal consisting of 400 mL Fresubin Energy Drink and 100 mL heavy cream with the addition of the 18F-FTHA radiotracer. 5 hours after consumption of the liquid mixed meal one static whole-body PET-scan will be performed with a duration of 1 hours. After the PET-scan participants will be provided with a meal. Subsequently, the investigator will make sure the participants is metabolic corrected and then the trial day is ended, and they can go home.
The three test days will be conducted in the same way, except for the timing of insulin bolus administration relative to the meal, which will vary as follows:
To correct for attenuation, the investigators will perform one ultra-low dose, non-contrast enhanced CT scan on each study day.
Results will be presented as means ± SD when possible. Primary and secondary outcomes will be analyzed using a two-way mixed model of linear regression with repeated measurements together with standard statistical methodology to compare results between study days. P-values \< 0.05 will be considered statistically significant. Statistical analyses will be carried out using R and visualization with GraphPad Prism.
The investigators base the sample size on our primary endpoint visceral meal fat uptake. Based on a previous (unpublished) study from our group with a test / re-test design using18F-FTHA PET together with a mixed meal, we can estimate a sample size based on the repeatability coefficient (RCP) of 45% in visceral adipose tissue. With a significance level of 0.05 and power of 80% and, the investigators will need 10 individuals to detect a 15% difference in meal fat uptake in adipose tissue. In the event of participant dropout, additional individuals will be recruited to ensure the intended sample size is maintained.
3,522 studies on the registry are indexed under Diabetes Mellitus, Type 1; 577 are open to participants now.
This study's planned enrollment of 10 is below the median of 40 across 2,649 interventional studies indexed under Diabetes Mellitus, Type 1.
Browse Diabetes Mellitus, Type 1 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:
Dietary Supplement: 400 mL Fresubin Energy Drink and 100 mL heavy cream with the addition of the 18F-FTHA radiotracer
Dietary Supplement: 400 mL Fresubin Energy Drink and 100 mL heavy cream with the addition of the 18F-FTHA radiotracer
Dietary Supplement: 400 mL Fresubin Energy Drink and 100 mL heavy cream with the addition of the 18F-FTHA radiotracer
400 mL Fresubin Energy Drink and 100 mL heavy cream with the addition of the 18F-FTHA radiotracer
Difference in meal fat storage in visceral adipose tissue
Difference in meal fat storage (18F-FTHA PET scan) in visceral adipose tissue following a liquid mixed meal and varying the timing or skipping of meal insulin boluses.
Time frame: 18F-FTHA PET scan 300 minutes after consumption of the liquid mixed meal
Difference in postprandial triglycerides
Postprandial triglycerides measured as area under the curve ( iAUC of plasma triglyceride concentration).
Time frame: -20 to 360 minutes after consumption of the mixed meal
Meal fat storage in target organs and tissues
Differences in meal fat storage in skeletal muscle, liver, brain, and subcutaneous fat adipose tissue (18F-FTHA PET scan) following a mixed meal, comparing different timings of insulin administration.
Time frame: 300 min after consumption of the mixed meal
Postprandial hormonal response and metabolites
Plasma concentrations of free fatty acids, insulin, glucagon, blood glucose, and potentially others following a liquid test meal, comparing different timings of insulin administration.
Time frame: -20 to 360 minutes after consumption of the mixed meal
Plan to share: No
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Aug 2025. 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