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

Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06094231
• Other study ID #: PRAGMATICS-Pilot
• Status: Recruiting
• Phase: N/A
• Start date: September 25, 2023
• Est. completion date: September 2025

Study information

• Verified date: October 2023
• Source: Department of Nephrology Clinic Ottakring Vienna
• Contact: Stefan Scherr, MDMD
• Phone: +431 49150 2605
• Email: stefan.scherr[@]gesundheitsverbund.at
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: September 2025
• Est. primary completion date: May 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Kidney Diseases
• Diabetes Mellitus
• Kidney Diseases
• Overweight
• Overweight and Obesity
• PreDiabetes
• Renal Insufficiency, Chronic

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
Austria	6th Medical Department with Nephrology and Dialysis, Clinik Ottakring	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Department of Nephrology Clinic Ottakring Vienna

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in HbA1c	Primary endpoint is difference in HbA1c after 3 months in the interventional group	after 3 Months
Secondary	Body composition	Body composition will be measured with a body composition monitoring device before and after the study period	after 3 Months
Secondary	Body weight	Body weight will be measured before and after the study period	after 3 Months
Secondary	Serum creatinine	Serum creatinine will be measured before and after the study period	after 3 Months
Secondary	Serum Cystatin C	Serum Cystatin C will be measured before and after the study period	after 3 Months
Secondary	Albuminuria	Albuminuria will be measured before and after the study period	after 3 Months
Secondary	Oral glucose tolerance	Oral glucose tolerance will be assessed using a 75g oral glucose tolerance test before and after the study period	after 3 Months
Secondary	Glucose variability	Glucose variability will be assessed using continuous glucose monitor	during the 3 Months of the study period
Secondary	Time in range	Time in range regarding glucose will be assessed using continuous glucose monitor	during the 3 Months of the study period