Treating Patients With Renal Impairment and Altered Glucose MetAbolism With TherapeutIc Carbohydrate Restriction and Sglt2-Inhibiton - a Pilot Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- Enrollment
- 4
- Locations
- 2
- Primary Endpoint
- Changes in HbA1c
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Interventional Arm
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.
Intervention: Therapeutic carbohydrate restriction combined with an SGLT-2-Inhibitor (Behavioral)
Control Arm
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.
Outcomes
Primary Outcomes
Changes in HbA1c
Time Frame: after 3 Months
Primary endpoint is difference in HbA1c after 3 months in the interventional group
Secondary Outcomes
- Serum creatinine(after 3 Months)
- Body composition(after 3 Months)
- Albuminuria(after 3 Months)
- Body weight(after 3 Months)
- Serum Cystatin C(after 3 Months)
- Oral glucose tolerance(after 3 Months)
- Glucose variability(during the 3 Months of the study period)
- Time in range(during the 3 Months of the study period)