Treating kidney disease and diabetes with low carbohydrate diet and medication
Treating Patients With Renal Impairment and Altered Glucose MetAbolism With TherapeutIc Carbohydrate Restriction and Sglt2-Inhibiton - a Pilot Study
This study is testing if a low carbohydrate diet combined with a diabetes medication can help people with chronic kidney disease and diabetes feel better.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Department of Nephrology Clinic Ottakring Vienna Academic / other |
| Locations | 1 site (Vienna) |
| Trial ID | NCT06094231 on ClinicalTrials.gov |
What this trial studies
This pilot study aims to evaluate the effectiveness and safety of combining a therapeutic carbohydrate restriction with the SGLT-2 inhibitor dapagliflozin in patients suffering from chronic kidney disease and prediabetes or type 2 diabetes mellitus. Participants will be randomly assigned to either an intervention group, which will receive dietary education and continuous glucose monitoring, or a control group that will continue standard care. The study will assess the outcomes of both groups to determine the potential benefits of this combined approach.
Who should consider this trial
Good fit: Ideal candidates include individuals with chronic kidney disease stage 3a-4, prediabetes or type 2 diabetes, and a body mass index over 25.
Not a fit: Patients with autoimmune diabetes, severe hypoglycemic episodes, or those who have had bariatric surgery may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could improve management of chronic kidney disease and diabetes, potentially leading to better health outcomes for patients.
How similar studies have performed: While the combination of dietary intervention and SGLT-2 inhibitors is a novel approach, similar studies have shown promise in managing diabetes and kidney disease separately.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Vienna
- 6th Medical Department with Nephrology and Dialysis, Clinik Ottakring — Vienna, Austria (Recruiting)
Study contacts
- Principal investigator: Stefan Scherr, MD — 6th Medical Department with Nephrology and Dialysis, Clinik Ottakring, Vienna, Austria
- Study coordinator: Stefan Scherr, MDMD
- Email: stefan.scherr@gesundheitsverbund.at
- Phone: +431 49150 2605
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.