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

NCT06094231 | Terminated

• 1 other identifier: PRAGMATICS-Pilot
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

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

Keywords

Low Carbohydrate Diet; Carbohydrate Restriction; SGLT-2-Inhibitors

Outcome Measures

Primary Outcomes (1)

• Changes in HbA1c

  Primary endpoint is difference in HbA1c after 3 months in the interventional group

  after 3 Months

Secondary Outcomes (8)

• Body composition

  after 3 Months

• Body weight

  after 3 Months

• Serum creatinine

  after 3 Months

• Serum Cystatin C

  after 3 Months

• Albuminuria

  after 3 Months

Study Arms (2)

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.

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

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.

Interventions

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.

Interventional Arm

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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 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

Sponsors & Collaborators

• Department of Nephrology Clinic Ottakring Vienna: lead

Study Sites (1)

6th Medical Department with Nephrology and Dialysis, Clinik Ottakring

Vienna, 1160, Austria

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Diabetes Mellitus; Prediabetic State; Overweight; Obesity

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms

Study Officials

• Stefan Scherr, MD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 6, 2023
• First Posted: October 23, 2023
• Study Start: September 25, 2023
• Primary Completion: April 13, 2026
• Study Completion: April 13, 2026
• Last Updated: April 16, 2026

Record last verified: 2026-04

Locations

AU (1)