Status:
UNKNOWN
Ketone Esters in T2DM
Lead Sponsor:
University of Portsmouth
Collaborating Sponsors:
Portsmouth Hospitals NHS Trust
Conditions:
Type 2 Diabetes
Eligibility:
All Genders
40-75 years
Phase:
NA
Brief Summary
Type 2 diabetes mellitus (T2DM) reduces the ability of the body to use sugar as a fuel. As an alternative people with T2DM can use fat from the blood stream instead. Fat is a good store of energy, how...
Detailed Description
Type 2 diabetes mellitus (T2DM) is a chronic and progressive metabolic disease associated with an increased prevalence of cardiovascular events, and therefore represents a significant global health co...
Eligibility Criteria
Inclusion
- • HbA1c \> 48 mmol/mol
Exclusion
- they present with severe renal impairment (eGFR \< 30ml/min)
- they use concomitantly GLP-1 Receptor agonists (which reduce glucagon and therefore hydroxybutyrate production);
- they currently participating in a very low calorie diet or restricted carbohydrate diet (which artificially increase endogenous ketone production);
- they present uncontrolled hypertension (systolic blood pressure \> 180 mmHg);
- they have a history of myocardial infarction or cerebro-vascular events in the last 3 months;
- have a a BMI \> 40 kg/m2;
- they are unable to exercise;
- they have an allergy or intolerance to ketone esters ;
- they are unable to give informed consent
- have any other serious medical condition which in the opinion of study investigators would interfere with safety or data interpretation.
Key Trial Info
Start Date :
April 26 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 21 2023
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT04854330
Start Date
April 26 2021
End Date
February 21 2023
Last Update
April 22 2021
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