Back to resultsTreating Patients With Renal Impairment and Altered Glucose MetAbolism With TherapeutIc Carbohydrate Restriction and Sglt2-Inhibiton - a Pilot Study
Primary Purpose
Chronic Kidney Diseases, Diabetes Mellitus, PreDiabetes
Status
Recruiting
Phase
Not Applicable
Locations
Austria
Study Type
Interventional
Intervention
Therapeutic carbohydrate restriction combined with an SGLT-2-Inhibitor
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Kidney Diseases focused on measuring Low Carbohydrate Diet, Carbohydrate Restriction, SGLT-2-Inhibitors
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
Sites / Locations
- 6th Medical Department with Nephrology and Dialysis, Clinik OttakringRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Interventional Arm
Control Arm
Arm Description
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.
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 Outcome Measures
Changes in HbA1c
Primary endpoint is difference in HbA1c after 3 months in the interventional group
Secondary Outcome Measures
Body composition
Body composition will be measured with a body composition monitoring device before and after the study period
Body weight
Body weight will be measured before and after the study period
Serum creatinine
Serum creatinine will be measured before and after the study period
Serum Cystatin C
Serum Cystatin C will be measured before and after the study period
Albuminuria
Albuminuria will be measured before and after the study period
Oral glucose tolerance
Oral glucose tolerance will be assessed using a 75g oral glucose tolerance test before and after the study period
Glucose variability
Glucose variability will be assessed using continuous glucose monitor
Time in range
Time in range regarding glucose will be assessed using continuous glucose monitor
Full Information
NCT ID
NCT06094231
First Posted
October 6, 2023
Last Updated
October 16, 2023
Sponsor
Department of Nephrology Clinic Ottakring Vienna
1. Study Identification
Unique Protocol Identification Number
NCT06094231
Brief Title
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
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 25, 2023 (Actual)
Primary Completion Date
May 2025 (Anticipated)
Study Completion Date
September 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Department of Nephrology Clinic Ottakring Vienna
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Diseases, Diabetes Mellitus, PreDiabetes, Overweight and Obesity
Keywords
Low Carbohydrate Diet, Carbohydrate Restriction, SGLT-2-Inhibitors
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Interventional Arm
Arm Type
Experimental
Arm Description
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.
Arm Title
Control Arm
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Therapeutic carbohydrate restriction combined with an SGLT-2-Inhibitor
Intervention Description
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.
Primary Outcome Measure Information:
Title
Changes in HbA1c
Description
Primary endpoint is difference in HbA1c after 3 months in the interventional group
Time Frame
after 3 Months
Secondary Outcome Measure Information:
Title
Body composition
Description
Body composition will be measured with a body composition monitoring device before and after the study period
Time Frame
after 3 Months
Title
Body weight
Description
Body weight will be measured before and after the study period
Time Frame
after 3 Months
Title
Serum creatinine
Description
Serum creatinine will be measured before and after the study period
Time Frame
after 3 Months
Title
Serum Cystatin C
Description
Serum Cystatin C will be measured before and after the study period
Time Frame
after 3 Months
Title
Albuminuria
Description
Albuminuria will be measured before and after the study period
Time Frame
after 3 Months
Title
Oral glucose tolerance
Description
Oral glucose tolerance will be assessed using a 75g oral glucose tolerance test before and after the study period
Time Frame
after 3 Months
Title
Glucose variability
Description
Glucose variability will be assessed using continuous glucose monitor
Time Frame
during the 3 Months of the study period
Title
Time in range
Description
Time in range regarding glucose will be assessed using continuous glucose monitor
Time Frame
during the 3 Months of the study period
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Stefan Scherr, MDMD
Phone
+431 49150 2605
Email
stefan.scherr@gesundheitsverbund.at
First Name & Middle Initial & Last Name or Official Title & Degree
Marcus D Säemann, MD
Phone
+431 49150 2605
Email
marcus.saemann@gesundheitsverbund.at
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stefan Scherr, MD
Organizational Affiliation
6th Medical Department with Nephrology and Dialysis, Clinik Ottakring, Vienna, Austria
Official's Role
Principal Investigator
Facility Information:
Facility Name
6th Medical Department with Nephrology and Dialysis, Clinik Ottakring
City
Vienna
ZIP/Postal Code
1160
Country
Austria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stefan Scherr, MD
Phone
+43 1 49150 2605
Email
stefan.scherr@gesundheitsverbund.at
First Name & Middle Initial & Last Name & Degree
Marcus D Säemann, MD
Phone
+43 1 49150 2605
Email
marcus.saemann@gesundheitsverbund.at
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Treating Patients With Renal Impairment and Altered Glucose MetAbolism With TherapeutIc Carbohydrate Restriction and Sglt2-Inhibiton - a Pilot Study
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