Status:
WITHDRAWN
Exogenous Ketones in People With Type 1 Diabetes
Lead Sponsor:
Insel Gruppe AG, University Hospital Bern
Conditions:
Ketosis, Diabetic
Eligibility:
MALE
18-45 years
Phase:
NA
Brief Summary
The aim of this pilot study is to investigate the metabolic effects of exogenous ketone ester food supplements, by assessing the change in blood acid-base balance, and the level of blood beta-hydroxy-...
Detailed Description
The ketone bodies acetoacetate, β-hydroxybutyrate (βHB) and acetone are small lipid-derived molecules that are produced in the liver under certain conditions such as starvation, very low carbohydrate ...
Eligibility Criteria
Inclusion
- Type 1 diabetes for \>1 year
- Male and female aged 18-45 years old
- HbA1c \<8.5% (69 mmol/mol) based on analysis from the central laboratory unit of Bern University Hospital
- Using either continuous subcutaneous insulin infusion or multiple daily injections
- Wearing a continuous glucose monitor (CGM) or flash glucose monitor (fGM)
- Written informed consent
Exclusion
- Physical or psychological disease likely to interfere with the normal conduct of the study and interpretation of the results as judged by the investigator
- Current treatment with drugs known to interfere with metabolism e.g. systemic corticosteroids, statins, SGLT2 inhibitors, GLP1 agonists
- Relevant diabetic complications as judged by the investigator
- Body mass index \> 30 kg/m2
- Uncontrolled hypertension (\>180/100 mmHg)
Key Trial Info
Start Date :
August 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2023
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04487678
Start Date
August 1 2023
End Date
December 1 2023
Last Update
September 1 2023
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