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

Department of Nephrology Clinic Ottakring Vienna

Status: Enrolling

Conditions: Chronic Kidney Diseases; Diabetes Mellitus; Overweight and Obesity; PreDiabetes

Treatments: Behavioral: Therapeutic carbohydrate restriction combined with an SGLT-2-Inhibitor

Study type: Interventional

Funder types: Other

Identifiers

NCT06094231

PRAGMATICS-Pilot

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No 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

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Interventional Arm

Experimental group

Description:

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.

Treatment:

Behavioral: Therapeutic carbohydrate restriction combined with an SGLT-2-Inhibitor

Control Arm

No Intervention group

Description:

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.