Treating Patients With Renal Impairment and Altered Glucose MetAbolism With TherapeutIc Carbohydrate Restriction and Sglt2-Inhibiton - a Pilot Study

Sponsor

Department of Nephrology Clinic Ottakring Vienna (Other)

Overall Status

Recruiting

CT.gov ID

NCT06094231

Collaborator

(none)

Enrollment

Location

Arms

23.2

Anticipated Duration (Months)

1.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Kidney Diseases Diabetes Mellitus PreDiabetes Overweight and Obesity	Behavioral: Therapeutic carbohydrate restriction combined with an SGLT-2-Inhibitor	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Treating Patients With Renal Impairment and Altered Glucose MetAbolism With TherapeutIc Carbohydrate Restriction and Sglt2-Inhibiton - a Pilot Study

Actual Study Start Date :

Sep 25, 2023

Anticipated Primary Completion Date :

May 1, 2025

Anticipated Study Completion Date :

Sep 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Interventional Arm 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.	Behavioral: Therapeutic 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.
No Intervention: Control Arm 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.

Arm

Intervention/Treatment

Experimental: Interventional Arm

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.

Behavioral: Therapeutic 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.

No Intervention: Control Arm

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.

Outcome Measures

Primary Outcome Measures

Changes in HbA1c [after 3 Months]
Primary endpoint is difference in HbA1c after 3 months in the interventional group

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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