Fast-Acting Insulins and Their Post-Meal Effects in Type 1 Diabetes

Phase 1

Recruiting

Conditions: Type 1 Diabetes

Registration Number: 2023-509217-37-00

Lead Sponsor: Katholisches Klinikum Bochum gGmbH

Brief Summary: The primary objective of the study is to optimize postprandial blood glucose profiles (avoiding excessive hyperglycemia and its consequences on accompanying oxidative stress reactions) by considering the velocity of gastric emptying through the selection of the most suitable rapid-acting mealtime insulin.

Detailed Description: Not available

Recruitment & Eligibility

Status: Ongoing, recruiting

Sex: Not specified

Target Recruitment: 20

Inclusion Criteria

Diabetes mellitus type 1

HbA1c ≥ 6.0% [42 mmol/l] and ≤ 8.0% [64 mmol/l]

Generally good overall health

Age ≥ 18 and ≤ 80 years

Body mass index (BMI) ≥ 18.5 and ≤ 35 kg/m²

Exclusion Criteria

Other types of diabetes (e.g., type 2 diabetes) or unspecified diabetes mellitus

Blood donation within the past 12 weeks prior to the study

Pregnancy

Clinically relevant thyroid dysfunction (hypo- and hyperthyroidism) without stable treatment

Substance abuse (including alcohol consumption of more than 20g of alcohol or more than 10 cigarettes per day)

Indications of a severe illness that could impact participation in the study or the results (e.g., epilepsy, cardiovascular disease, pulmonary disease, active cancer)

Participation in other medical studies within the past three months

Inability to provide informed consent

Unwillingness to consume the test meal (e.g., refusal to eat chicken eggs)

Conventional insulin therapy

Proliferative retinopathy

Inadequate metabolic control (HbA1c < 6.0% [42 mmol/l] or > 8.0% [64 mmol/l])

Allergies or intolerances that could hinder the study's execution

Recurrent or severe hypoglycemia within the past four weeks before study enrollment, indicating a need for therapy optimization

Positive medical history of gastrointestinal diseases, especially symptomatic upper or lower gastrointestinal tract disorders (e.g., Crohn's disease, ulcerative colitis, celiac disease, pancreatitis, gastric conditions like gastroparesis)

History of gastrointestinal surgery (except uncomplicated cholecystectomy or appendectomy)

Use of medication within 2 weeks before the study or ongoing use of medications that could affect gastrointestinal motility, body weight, or appetite

Chronic kidney insufficiency (eGFR < 30 ml/min according to CKD-EPI formula)

Chronic liver disease (transaminases > 2 times the upper normal limit)

Anemia (Hb < 11.5 mg/dl in women or < 13.5 mg/dl in men)

Study & Design

Study Type: Not specified

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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)		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 Outcome Measures

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

Trial Locations

Locations (1): Katholisches Klinikum Bochum gGmbH
🇩🇪
Bochum, Germany
Katholisches Klinikum Bochum gGmbH
🇩🇪Bochum, Germany
Daniel Quast
Site contact
+49023245090
daniel.quast@ruhr-uni-bochum.de