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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Interventional Arm | Experimental | The patients randomized to the interventional Arm will be simultaneously treated with therapeutic carbohydrate restriction and dapagliflozin for a period of three months. During this time repeated measurements of blood ketone levels and a continuous glucose monitoring will be performed. |
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| Control Arm | No Intervention | The patients randomized to the control arm will continue to receive the standard of care for chronic kidney disease and prediabetes or diabetes, which includes the use of dapagliflozin. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Therapeutic carbohydrate restriction combined with an SGLT-2-Inhibitor | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in HbA1c | Primary endpoint is difference in HbA1c after 3 months in the interventional group | after 3 Months |
| Measure | Description | Time Frame |
|---|---|---|
| Body composition | Body composition will be measured with a body composition monitoring device before and after the study period | after 3 Months |
| Body weight | Body weight will be measured before and after the study period |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stefan Scherr, MD | 6th Medical Department with Nephrology and Dialysis, Clinik Ottakring, Vienna, Austria | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 6th Medical Department with Nephrology and Dialysis, Clinik Ottakring | Vienna | 1160 | Austria |
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| after 3 Months |
| Serum creatinine | Serum creatinine will be measured before and after the study period | after 3 Months |
| Serum Cystatin C | Serum Cystatin C will be measured before and after the study period | after 3 Months |
| Albuminuria | Albuminuria will be measured before and after the study period | 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 | after 3 Months |
| Glucose variability | Glucose variability will be assessed using continuous glucose monitor | during the 3 Months of the study period |
| Time in range | Time in range regarding glucose will be assessed using continuous glucose monitor | during the 3 Months of the study period |
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D003920 | Diabetes Mellitus |
| D011236 | Prediabetic State |
| D050177 | Overweight |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
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