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

NCT ID: NCT06094231

Last Updated: 2023-10-23

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-09-25
• Study Completion Date: 2025-09-30

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Therapeutic carbohydrate restriction combined with an SGLT-2-Inhibitor

Intervention Type: 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.

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Department of Nephrology Clinic Ottakring Vienna

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Stefan Scherr, MD

Role: PRINCIPAL_INVESTIGATOR

6th Medical Department with Nephrology and Dialysis, Clinik Ottakring, Vienna, Austria

Locations

6th Medical Department with Nephrology and Dialysis, Clinik Ottakring

Vienna, , Austria

Site Status: RECRUITING

Countries

Austria

Central Contacts

Stefan Scherr, MDMD

Role: CONTACT

stefan.scherr@gesundheitsverbund.at

+431 49150 2605

Marcus D Säemann, MD

Role: CONTACT

marcus.saemann@gesundheitsverbund.at

+431 49150 2605

Facility Contacts

Stefan Scherr, MD

Role: primary

stefan.scherr@gesundheitsverbund.at

+43 1 49150 2605

Marcus D Säemann, MD

Role: backup

marcus.saemann@gesundheitsverbund.at

+43 1 49150 2605

Other Identifiers

PRAGMATICS-Pilot

Identifier Type: -

Identifier Source: org_study_id