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

Not Applicable

Recruiting

• Conditions: Overweight and Obesity; PreDiabetes; Chronic Kidney Diseases; Diabetes Mellitus
• Interventions: Behavioral: Therapeutic carbohydrate restriction combined with an SGLT-2-Inhibitor

• Registration Number: NCT06094231
• Lead Sponsor: Department of Nephrology Clinic Ottakring Vienna

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-09-25
• Status Verified: 2023-10
• Study First Submitted: 2023-10-06
• Study First Submitted QC: 2023-10-16
• Last Update Submitted: 2023-10-16
• Study First Posted: 2023-10-23
• Last Update Posted: 2023-10-23
• Primary Completion: 2025-05
• Study Completion: 2025-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Interventional Arm	Therapeutic carbohydrate restriction combined with an SGLT-2-Inhibitor	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.

Primary Outcome Measures

Name	Time	Method
Changes in HbA1c	after 3 Months	Primary endpoint is difference in HbA1c after 3 months in the interventional group

Secondary Outcome Measures

Name	Time	Method
Body composition	after 3 Months	Body composition will be measured with a body composition monitoring device before and after the study period
Albuminuria	after 3 Months	Albuminuria will be measured before and after the study period
Body weight	after 3 Months	Body weight 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
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
Serum creatinine	after 3 Months	Serum creatinine will be measured before and after the study period

Trial Locations

Locations (1)

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