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Influence of various fast-acting mealtime insulin preparations in individuals with type 1 diabetes, with slow, moderate, and rapid gastric emptying, on postprandial blood glucose and the formation of reactive oxygen species

Status
Recruiting
Phases
Phase 1
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-509217-37-00
Acronym
KKB_2023_FActIn-T1DM
Enrollment
20
Registered
2024-03-27
Start date
2024-06-25
Completion date
Unknown
Last updated
2025-09-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 1 Diabetes

Brief summary

The primary endpoint is defined as the proportion of participants who achieve the lowest AUC glucose with ultra-rapid-acting insulin analog in the tertiles with the fastest vs. the slowest gastric emptying (t1/2), compared to the proportion of participants who achieve the lowest AUCglucose with regular insulin in the tertiles with the slowest vs. the fastest gastric emptying (t1/2)

Detailed description

Comparison of meal-associated excursions of ROS (Nitrotyrosine, oxidized Low-Density Lipoproteins (oxLDL)), Comparison of meal-associated excursions of plasma glucose and triglyceride concentrations, Comparison of gastric emptying rates (t1/2), Coefficient of variation of gastric emptying variability (t1/2), Correlation of AUCglucose with gastric emptying (t1/2) considering the choice of insulin preparation (ultra-rapid-acting insulin, rapid-acting insulin, and regular insulin)

Interventions

DRUGHuminsulin® Normal 100 100 I.E./ml Injektionslösung in Durchstechflasche

Sponsors

Katholisches Klinikum Bochum gGmbH
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
The primary endpoint is defined as the proportion of participants who achieve the lowest AUC glucose with ultra-rapid-acting insulin analog in the tertiles with the fastest vs. the slowest gastric emptying (t1/2), compared to the proportion of participants who achieve the lowest AUCglucose with regular insulin in the tertiles with the slowest vs. the fastest gastric emptying (t1/2)

Secondary

MeasureTime frame
Comparison of meal-associated excursions of ROS (Nitrotyrosine, oxidized Low-Density Lipoproteins (oxLDL)), Comparison of meal-associated excursions of plasma glucose and triglyceride concentrations, Comparison of gastric emptying rates (t1/2), Coefficient of variation of gastric emptying variability (t1/2), Correlation of AUCglucose with gastric emptying (t1/2) considering the choice of insulin preparation (ultra-rapid-acting insulin, rapid-acting insulin, and regular insulin)

Countries

Germany

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026