TerminatedNot Applicable

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

Stopped: Low number of participants

Austria4 participantsStarted 2023-09-25

Plain-language 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.

Who can participate

Age range18 Years – 70 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Changes in HbA1c

Timeframe: after 3 Months

Trial details

NCT IDNCT06094231

SponsorDepartment of Nephrology Clinic Ottakring Vienna

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-04-13