This randomized controlled trail will evaluate the efficacy and safety of a simultaneous therapeutic carbohydrate restriction and treatment with the Sodium-Glucose-Transporter-2-Inhibitor dapagliflozin in comparison to the standard of care treatment in patients with chronic kidney disease and prediabetes or type 2 diabetes mellitus. Participants will be randomized 1:1. The interventional group will be educated on how to implement a therapeutic carbohydrate restriction (50-100 grams of carbohydrates per day). Regarding safety, the patients of the interventional group will be provided with continuous glucose monitoring systems and blood ketone meters. The participants of the control group will continue to receive the standard of care therapy for the treatment of chronic kidney disease and prediabetes or type 2 diabetes mellitus. Both groups will be treated with dapagliflozin.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
4
The patients will be educated on how to implement a therapeutic carbohydrate restriction, which consists of 50 to 130 grams of carbohydrate per day, simultaneously they will continue to receive the SGLT-2-Inhibitor dapagliflozin.
6th Medical Department with Nephrology and Dialysis, Clinik Ottakring
Vienna, Austria
Changes in HbA1c
Primary endpoint is difference in HbA1c after 3 months in the interventional group
Time frame: after 3 Months
Body composition
Body composition will be measured with a body composition monitoring device before and after the study period
Time frame: after 3 Months
Body weight
Body weight will be measured before and after the study period
Time frame: after 3 Months
Serum creatinine
Serum creatinine will be measured before and after the study period
Time frame: after 3 Months
Serum Cystatin C
Serum Cystatin C will be measured before and after the study period
Time frame: after 3 Months
Albuminuria
Albuminuria will be measured before and after the study period
Time frame: after 3 Months
Oral glucose tolerance
Oral glucose tolerance will be assessed using a 75g oral glucose tolerance test before and after the study period
Time frame: after 3 Months
Glucose variability
Glucose variability will be assessed using continuous glucose monitor
Time frame: during the 3 Months of the study period
Time in range
Time in range regarding glucose will be assessed using continuous glucose monitor
Time frame: during the 3 Months of the study period
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