Clinical trial NCT06094231: Treating Patients With Renal Impairment and Altered Glucose MetAbolism With TherapeutIc Carbohydrate Restriction and Sglt2-Inhibiton - a Pilot Study
Official title: Treating Patients With Renal Impairment and Altered Glucose MetAbolism With TherapeutIc Carbohydrate Restriction and Sglt2-Inhibiton - a Pilot Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Chronic Kidney Diseases
Diabetes Mellitus
PreDiabetes
Overweight and Obesity
Keywords: Low Carbohydrate Diet
Carbohydrate Restriction
SGLT-2-Inhibitors
Lead sponsor: Department of Nephrology Clinic Ottakring Vienna
Sponsor class: OTHER
First posted: 2023-10-23
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Changes in HbA1c
timeFrame: after 3 Months
Secondary outcomes:
measure: Body composition
timeFrame: after 3 Months
measure: Body weight
timeFrame: after 3 Months
measure: Serum creatinine
timeFrame: after 3 Months
measure: Serum Cystatin C
timeFrame: after 3 Months
measure: Albuminuria
timeFrame: after 3 Months
measure: Oral glucose tolerance
timeFrame: after 3 Months
measure: Glucose variability
timeFrame: during the 3 Months of the study period
measure: Time in range
timeFrame: during the 3 Months of the study period
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: 6th Medical Department with Nephrology and Dialysis, Clinik Ottakring
Study officials:
affiliation: 6th Medical Department with Nephrology and Dialysis, Clinik Ottakring, Vienna, Austria
name: Stefan Scherr, MD
role: PRINCIPAL_INVESTIGATOR
References: