NCT07172672

Brief 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. 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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
18mo left

Started Nov 2025

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress26%
Nov 2025Nov 2027

First Submitted

Initial submission to the registry

September 8, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 15, 2025

Completed
2 months until next milestone

Study Start

First participant enrolled

November 1, 2025

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2027

Expected
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2027

Last Updated

September 26, 2025

Status Verified

August 1, 2025

Enrollment Period

1.3 years

First QC Date

September 8, 2025

Last Update Submit

September 22, 2025

Conditions

Postprandial Lipid MetabolismType 1 Diabetes (T1D)

Keywords

FTHA PETInsulinPostprandial metabolismHumanMeal fat storage in skeletal muscle, liver, brain, and subcutaneous fat adipose tissue

Outcome Measures

Primary Outcomes (1)

  • 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.

    18F-FTHA PET scan 300 minutes after consumption of the liquid mixed meal

Secondary Outcomes (3)

  • Difference in postprandial triglycerides

    -20 to 360 minutes after consumption of the mixed meal

  • Meal fat storage in target organs and tissues

    300 min after consumption of the mixed meal

  • Postprandial hormonal response and metabolites

    -20 to 360 minutes after consumption of the mixed meal

Study Arms (3)

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

Interventions

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

Meal insulin bolus 20 min after consumption of a liquid mixed mealMeal insulin bolus 20 min before consumption of a liquid mixed mealSkipping the insulin bolus

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Type 1 diabetes duration \> 3 years or c-peptide negative
  • Written and informed consent

You may not qualify if:

  • 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
  • Doesn't speak and understand Danish.
  • Severe claustrophobia.
  • Commitment to special diets

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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, Denmark

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1Insulin Resistance

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System DiseasesHyperinsulinism

Study Officials

  • Esben Søndergaard, MD, PhD

    Steno Diabetes Center Aarhus, Aarhus University Hospital, 8200 Aarhus, Denmark

    STUDY DIRECTOR

Central Study Contacts

Jens H. Voigt, MD

CONTACT

0026395294Jens.voigt@clin.au.dk

Esben Søndergaaard, MD, PhD

CONTACT

004528730943Esben.sondergaard@clin.au.dk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 8, 2025

First Posted

September 15, 2025

Study Start

November 1, 2025

Primary Completion (Estimated)

February 1, 2027

Study Completion (Estimated)

November 1, 2027

Last Updated

September 26, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations

DK(1)