Postprandial Lipid MetabolismNCT07172672
The TiMeD-T1D Project
A study testing 400 mL Fresubin Energy Drink and 100 mL heavy cream with the addition of the 18F-FTHA radiotracer in people with Postprandial Lipid Metabolism and Type 1 Diabetes (T1D), run by University of Aarhus at 1 site in Denmark.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Postprandial Lipid Metabolism, Type 1 Diabetes (T1D)
- What is being tested?
- 400 mL Fresubin Energy Drink and 100 mL heavy cream with the addition of the 18F-FTHA radiotracer
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Nov 2025to 1 Nov 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Type 1 diabetes duration > 3 years or c-peptide negative
- Written and informed consent
Who cannot join
- Medicine with an impact on blood glucose or blood pressure
- Affected screening blood sample as evaluated by the clinical responsible investigator.
- Alcohol or substance abuse
- BMI > 35 kg/m2 or < 18.5 kg/m2
- Participation in other clinical trials involving ionized radiation within the last 6 months
- Lactose intolerance
Show all 9Show fewer
- Doesn't speak and understand Danish.
- Severe claustrophobia.
- Commitment to special diets
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark1 site
Department of Nuclear Medicine & PET-Centre, AUH Palle Juul-Jensens Blvd. 165, 8200 Aarhus N, Denmark and Medical Research Laboratories/Steno Diabetes Center Aarhus, AUH Palle Juul-Jensens Blvd. 11, 8200 Aarhus N, Denmark
Aarhus, 8200
Jens H Voigt, MD, 26395294, Jens.voigt@clin.au.dk
About this study
Official title: Impact of Meal Insulin Dose Timing on Meal Fat Storage in Patients With Type 1 Diabetes: a Randomized Control Trial - the TiMeD-T1D Project
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.
Read the detailed description
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:
- Meal insulin bolus 20 min before consumption of a liquid mixed meal (as recommended)
- Meal insulin bolus 20 min after consumption of a liquid mixed meal
- Skipping the insulin bolus Insulin will be administered subcutaneously, with the dose determined based on the composition of the liquid mixed meal.
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.
- Being tested
- 400 mL Fresubin Energy Drink and 100 mL heavy cream with the addition of the 18F-FTHA radiotracer
- Keywords
- FTHA PET, Insulin, Postprandial metabolism, Human, Meal fat storage in skeletal muscle, liver, brain, and subcutaneous fat adipose tissue
- Medical subject headings
- Diabetes Mellitus, Type 1, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
400 mL Fresubin Energy Drink and 100 mL heavy cream with the addition of the 18F-FTHA radiotracerDietary supplement
400 mL Fresubin Energy Drink and 100 mL heavy cream with the addition of the 18F-FTHA radiotracer
| Study group | Role | What they receive |
|---|---|---|
| Meal insulin bolus 20 min before consumption of a liquid mixed meal | Experimental | Not described Receives: Dietary Supplement: 400 mL Fresubin Energy Drink and 100 mL heavy cream with the addition of the 18F-FTHA radiotracer |
| Meal insulin bolus 20 min after consumption of a liquid mixed meal | Experimental | Not described Receives: Dietary Supplement: 400 mL Fresubin Energy Drink and 100 mL heavy cream with the addition of the 18F-FTHA radiotracer |
| Skipping the insulin bolus | Experimental | Not described Receives: Dietary Supplement: 400 mL Fresubin Energy Drink and 100 mL heavy cream with the addition of the 18F-FTHA radiotracer |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 18F-FTHA PET scan 300 minutes after consumption of the liquid mixed meal
Secondary outcomes (3)
Difference in postprandial triglycerides
Postprandial triglycerides measured as area under the curve ( iAUC of plasma triglyceride concentration).
Measured: -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.
Measured: 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.
Measured: -20 to 360 minutes after consumption of the mixed meal
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2025
- Study start1 Nov 2025 (estimated)
- Primary completion1 Feb 2027 (estimated)
- Study completion1 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postprandial Lipid MetabolismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Esben Søndergaard, MD, PhD, Study director, Steno Diabetes Center Aarhus, Aarhus University Hospital, 8200 Aarhus, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07172672
- Sponsor's protocol ID
- TiMed-T1D
- Status last verified
- Aug 2025
- First submitted
- 8 Sep 2025
- Last updated
- 26 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Meal Insulin Dose Timing on Meal Fat Storage in Patients With Type 1 Diabetes: a Randomized Control Trial - the TiMeD-T1D Project
- ClinicalTrials.gov ID
- NCT07172672
- Acronym / sponsor ID
- TiMed-T1D
- Keywords
- FTHA PET, Insulin, Postprandial metabolism, Human, Meal fat storage in skeletal muscle, liver, brain, and subcutaneous fat adipose tissue
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- 1 Nov 2025 (estimated)
- Primary completion
- 1 Feb 2027 (estimated)
- Study completion
- 1 Nov 2027 (estimated)
- First posted
- 15 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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:
- Meal insulin bolus 20 min before consumption of a liquid mixed meal (as recommended)
- Meal insulin bolus 20 min after consumption of a liquid mixed meal
- Skipping the insulin bolus Insulin will be administered subcutaneously, with the dose determined based on the composition of the liquid mixed meal.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Meal insulin bolus 20 min before consumption of a liquid mixed meal | Experimental | Dietary Supplement: 400 mL Fresubin Energy Drink and 100 mL heavy cream with the addition of the 18F-FTHA radiotracer |
| Meal insulin bolus 20 min after consumption of a liquid mixed meal | Experimental | Dietary Supplement: 400 mL Fresubin Energy Drink and 100 mL heavy cream with the addition of the 18F-FTHA radiotracer |
| Skipping the insulin bolus | Experimental | Dietary Supplement: 400 mL Fresubin Energy Drink and 100 mL heavy cream with the addition of the 18F-FTHA radiotracer |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Type 1 diabetes duration > 3 years or c-peptide negative
- Written and informed consent
Key exclusion criteria (9 listed)
- Medicine with an impact on blood glucose or blood pressure
- Affected screening blood sample as evaluated by the clinical responsible investigator.
- Alcohol or substance abuse
- BMI > 35 kg/m2 or < 18.5 kg/m2
- Participation in other clinical trials involving ionized radiation within the last 6 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 400 mL Fresubin Energy Drink and 100 mL heavy cream with the addition of the 18F-FTHA radiotracer400 mL Fresubin Energy Drink and 100 mL heavy cream with the addition of the 18F-FTHA radiotracer | Dietary supplement | Meal insulin bolus 20 min after consumption of a liquid mixed meal, Meal insulin bolus 20 min before consumption of a liquid mixed meal, Skipping the insulin bolus |
Primary outcome
Difference in meal fat storage in visceral adipose tissue
Time frame: 18F-FTHA PET scan 300 minutes after consumption of the liquid mixed meal
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.
3 secondary outcomes
Difference in postprandial triglycerides
Time frame: -20 to 360 minutes after consumption of the mixed meal
Meal fat storage in target organs and tissues
Time frame: 300 min after consumption of the mixed meal
Postprandial hormonal response and metabolites
Time frame: -20 to 360 minutes after consumption of the mixed meal
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Esben Søndergaard, MD, PhD study director
Steno Diabetes Center Aarhus, Aarhus University Hospital, 8200 Aarhus, Denmark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 400 mL Fresubin Energy Drink and 100 mL heavy cream with the addition of the 18F-FTHA radiotracer in people with Postprandial Lipid Metabolism and Type 1 Diabetes (T1D), run by University of Aarhus at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 26 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jens H. Voigt, MD (0026395294, Jens.voigt@clin.au.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in meal fat storage in visceral adipose tissue (time frame: 18F-FTHA PET scan 300 minutes after consumption of the liquid mixed meal). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2025.