Status:
UNKNOWN
Treating Patients With Renal Impairment and Altered Glucose MetAbolism With TherapeutIc Carbohydrate Restriction and Sglt2-Inhibiton - a Pilot Study
Lead Sponsor:
Department of Nephrology Clinic Ottakring Vienna
Conditions:
Chronic Kidney Diseases
Diabetes Mellitus
Eligibility:
All Genders
18-70 years
Phase:
NA
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 dapagliflozi...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 25 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2025
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT06094231
Start Date
September 25 2023
End Date
September 1 2025
Last Update
October 23 2023
Active Locations (1)
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1
6th Medical Department with Nephrology and Dialysis, Clinik Ottakring
Vienna, Austria, 1160