Chronic Kidney Diseases, Diabetes Mellitus, Overweight and Obesity, PreDiabetes
Conditions
Keywords
Low Carbohydrate Diet, Carbohydrate Restriction, SGLT-2-Inhibitors
Brief summary
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.
Interventions
BEHAVIORALTherapeutic carbohydrate restriction combined with an SGLT-2-Inhibitor
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.
Sponsors
Department of Nephrology Clinic Ottakring Vienna
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Chronic Kidney Disease Stage KDIGO 3a-4 (eGFR eGFR 25-59 mg/min/1.73m²) * Prediabetes or Diabetes according to the Guideline of the American Diabetes Association (HbA1c \>5,7 percent, or fasting glucose values \> 100 mg/dL, or glucose levels \> 140 mg/dL at 2h during an oral glucose tolerance test) * Being overweight (Body Mass Index \> 25.0 kg/m²) * Being able to independently: * \- Perform measurements of blood glucose and ketone levels * \- Use a continous glucose monitor * \- Contact the study team
Exclusion criteria
* Patients who are allergic to SGLT-2-Inhibitors * Patients with autoimmune diabetes (Typ 1 or LADA) * Patients with pancreoprivic diabetes * Patients with a history of ketoacidosis or lactate acidosis * Patients with severe hypoglycemic episodes in the 6 moths prior to inclusion * Patients with bariatric surgery (in the past or planed) * Patients with nephritic range proteinuria (\>3,5g of Albumin/day) * Patients with active malignant diseases * Pregnant or breastfeeding patients
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in HbA1c | after 3 Months | Primary endpoint is difference in HbA1c after 3 months in the interventional group |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Body composition | after 3 Months | Body composition will be measured with a body composition monitoring device before and after the study period |
| Body weight | after 3 Months | Body weight will be measured before and after the study period |
| Serum creatinine | after 3 Months | Serum creatinine will be measured before and after the study period |
| Serum Cystatin C | after 3 Months | Serum Cystatin C will be measured before and after the study period |
| Albuminuria | after 3 Months | Albuminuria will be measured before and after the study period |
| Oral glucose tolerance | after 3 Months | Oral glucose tolerance will be assessed using a 75g oral glucose tolerance test before and after the study period |
| Glucose variability | during the 3 Months of the study period | Glucose variability will be assessed using continuous glucose monitor |
| Time in range | during the 3 Months of the study period | Time in range regarding glucose will be assessed using continuous glucose monitor |
Countries
Austria
Contacts
PRINCIPAL_INVESTIGATORStefan Scherr, MD
6th Medical Department with Nephrology and Dialysis, Clinik Ottakring, Vienna, Austria
Outcome results
None listed