Chronic Kidney DiseasesNCT06094231
Treating Patients With Renal Impairment and Altered Glucose MetAbolism With TherapeutIc Carbohydrate Restriction and Sglt2-Inhibiton - a Pilot Study
A study testing Therapeutic carbohydrate restriction combined with an SGLT-2-Inhibitor in people with Chronic Kidney Diseases and Diabetes Mellitus, run by Department of Nephrology Clinic Ottakring Vienna at 1 site in Austria.
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… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Chronic Kidney Diseases, Diabetes Mellitus, PreDiabetes
- What is being tested?
- Therapeutic carbohydrate restriction combined with an SGLT-2-Inhibitor
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteAustria
- Study dates
- 25 Sep 2023to 13 Apr 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 9Show fewer
- Patients with nephritic range proteinuria (>3,5g of Albumin/day)
- Patients with active malignant diseases
- Pregnant or breastfeeding patients
Trial locations and contacts
1 site in 1 country.
Austria1 site
6th Medical Department with Nephrology and Dialysis, Clinik Ottakring
Vienna, 1160
About this study
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.
- Being tested
- Therapeutic carbohydrate restriction combined with an SGLT-2-Inhibitor
- Keywords
- Low Carbohydrate Diet, Carbohydrate Restriction, SGLT-2-Inhibitors
- Medical subject headings
- Renal Insufficiency, Chronic, Diabetes Mellitus, Prediabetic State, Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Therapeutic carbohydrate restriction combined with an SGLT-2-InhibitorBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Interventional Arm | Experimental | 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. Receives: Behavioral: Therapeutic carbohydrate restriction combined with an SGLT-2-Inhibitor |
| Control Arm | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in HbA1c
Primary endpoint is difference in HbA1c after 3 months in the interventional group
Measured: after 3 Months
Secondary outcomes (8)
Body composition
Body composition will be measured with a body composition monitoring device before and after the study period
Measured: after 3 Months
Body weight
Body weight will be measured before and after the study period
Measured: after 3 Months
Serum creatinine
Serum creatinine will be measured before and after the study period
Measured: after 3 Months
Serum Cystatin C
Serum Cystatin C will be measured before and after the study period
Measured: after 3 Months
Albuminuria
Albuminuria will be measured before and after the study period
Measured: after 3 Months
Oral glucose tolerance
Oral glucose tolerance will be assessed using a 75g oral glucose tolerance test before and after the study period
Measured: after 3 Months
Glucose variability
Glucose variability will be assessed using continuous glucose monitor
Measured: during the 3 Months of the study period
Time in range
Time in range regarding glucose will be assessed using continuous glucose monitor
Measured: during the 3 Months of the study period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2023
- Study start25 Sep 2023
- Primary completion13 Apr 2026
- Study completion13 Apr 2026
Why it stopped: Low number of participants
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Department of Nephrology Clinic Ottakring Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stefan Scherr, MD, Principal investigator, 6th Medical Department with Nephrology and Dialysis, Clinik Ottakring, Vienna, Austria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06094231
- Sponsor's protocol ID
- PRAGMATICS-Pilot
- Status last verified
- Apr 2026
- First submitted
- 6 Oct 2023
- Last updated
- 16 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treating Patients With Renal Impairment and Altered Glucose MetAbolism With TherapeutIc Carbohydrate Restriction and Sglt2-Inhibiton - a Pilot Study
- ClinicalTrials.gov ID
- NCT06094231
- Acronym / sponsor ID
- PRAGMATICS-Pilot
- Keywords
- Low Carbohydrate Diet, Carbohydrate Restriction, SGLT-2-Inhibitors
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Low number of participants
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Department of Nephrology Clinic Ottakring ViennaUniversity, hospital or other
- Study start
- 25 Sep 2023 (actual)
- Primary completion
- 13 Apr 2026 (actual)
- Study completion
- 13 Apr 2026 (actual)
- First posted
- 23 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Interventional Arm | Experimental | Behavioral: Therapeutic carbohydrate restriction combined with an SGLT-2-InhibitorThe 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. |
| Control Arm | No intervention | –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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Therapeutic carbohydrate restriction combined with an SGLT-2-InhibitorThe 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. | Behavioural | Interventional Arm |
Primary outcome
Changes in HbA1c
Time frame: after 3 Months
Primary endpoint is difference in HbA1c after 3 months in the interventional group
8 secondary outcomes
Body composition
Time frame: after 3 Months
Body weight
Time frame: after 3 Months
Serum creatinine
Time frame: after 3 Months
Serum Cystatin C
Time frame: after 3 Months
Albuminuria
Time frame: after 3 Months
Oral glucose tolerance
Time frame: after 3 Months
Glucose variability
Time frame: during the 3 Months of the study period
Time in range
Time frame: during the 3 Months of the study period
Results and safety
The study was stopped early (reason given: Low number of participants). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stefan Scherr, MD principal investigator
6th Medical Department with Nephrology and Dialysis, Clinik Ottakring, Vienna, Austria
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Therapeutic carbohydrate restriction combined with an SGLT-2-Inhibitor in people with Chronic Kidney Diseases and Diabetes Mellitus, run by Department of Nephrology Clinic Ottakring Vienna at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 16 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Low number of participants). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in HbA1c (time frame: after 3 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2026.