NCT06094231Terminated
Treating Patients With Renal Impairment and Altered Glucose MetAbolism With TherapeutIc Carbohydrate Restriction and Sglt2-Inhibiton - a Pilot Study
Source: ClinicalTrials.gov · Last updated 16 Apr 2026
Reason given: Low number of participants
Brief summary (registry, in English)
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.
- Status (registry)
- Terminated
- Study type
- Interventional
- Enrollment
- 4 (actual)
- First submitted
- 6 Oct 2023
- Start date
- 25 Sept 2023
- Primary completion date
- 13 Apr 2026
- Lead sponsor
- Department of Nephrology Clinic Ottakring Vienna
- Diseases
- Chronic kidney disease, Obesity
- NCT number
- NCT06094231
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients with severe hypoglycemic episodes in the 6 moths prior to inclusion
- Patients with bariatric surgery (in the past or planed)
Other illness
- 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 active malignant diseases
Lab values
- Patients with nephritic range proteinuria (>3,5g of Albumin/day)
Other
- Pregnant or breastfeeding patients
Who the study is looking for
- 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
Age in the registry: 18 years to 70 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| 6th Medical Department with Nephrology and Dialysis, Clinik Ottakring | Vienna | Austria | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.