None listed
Conditions
Brief summary
The aim of this study is to determine the effects of salt restriction in people with type 2 diabetes and chronic kidney disease treated with the sodium-glucose co-transporter 2 inhibitor, empagliflozin compared with treatment with empagliflozin alone during liberal sodium intake. We hypothesise that in people with type 2 diabetes and chronic kidney disease treated with empagliflozin, salt restriction results in a greater reduction in 24-hour ambulatory blood pressure compared with liberal salt intake.
Interventions
Empagliflozin 10 mg once daily oral tablet for 4 weeks combined with sodium restriction for 4 weeks.
Participants will be randomised to start with empagliflozin combined with sodium restriction for 4 weeks or empagliflozin combined with their usual sodium intake for 4 weeks. Participants will then undergo a 2-week washout period and crossover to the alternative sodium intervention (usual sodium intake or sodium restriction) combined with empagliflozin for 4 weeks.
Adherence to taking empaglifloz
Empagliflozin 10 mg once daily oral tablet for 4 weeks combined with sodium restriction for 4 weeks. Participants will be randomised to start with empagliflozin combined with sodium restriction for 4 weeks or empagliflozin combined with their usual sodium intake for 4 weeks. Participants will then undergo a 2-week washout period and crossover to the alternative sodium intervention (usual sodium intake or sodium restriction) combined with empagliflozin for 4 weeks. Adherence to taking empagliflozin will be monitored with the use of a participant study diary to record the administration of each empagliflozin tablet. A Dietician with minimum 3 years experience will provide education to participants individually regarding sodium restriction over the internet or via telephone call. Participants can receive this virtual education at their homes. The Dietician will provide an initial education session (approximately 1-2 hours) at the time of randomisation to sodium restriction (in the week prior to starting empagliflozin treatment) and then have a follow-up session (approximately 30 minutes - 1 hour) 1-2 weeks after the initial individual education and after starting empagliflozin treatment. Information provided to participants at the initial education session will include discussion of foods high in sodium and how to substitute high sodium foods for foods lower in sodium during the sodium restriction period. At the follow-up session the Dietician will discuss the participant's progress with a sodium-restricted diet. The participant will be asked to follow a sodium-restricted diet for 4 weeks. Changes to sodium intake will be monitored with a participant food diary.
Sponsors
St Vincent's Hospital
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
- Age range: 18 - 75 years - Diagnosis of type 2 diabetes and HbA1c up to 10% - Stage 2, 3 or 4 CKD (eGFR 60-89 mL/min/1.73 m2 and urine albumin-to-creatinine ratio >30 mg/g, eGFR 30-59 mL/min/1.73m2 or 15 – 29 mL/min/1.73m2, respectively) at the time of screening, and stable renal function defined as a difference of <30% between two consecutive eGFR in the 3 months before the screening visit - On stable anti-hypertensive dose of an angiotensin-converting-enzyme (ACE) inhibitor or angiotensin-receptor blocker (ARB) in the one month before the screening visit - Willing to give written informed consent and willingness to participate to and comply with the study
Exclusion criteria
- Symptomatic hypotension, systolic blood pressure less than 110 mmHg or hypertension – systolic blood pressure greater than 170 mmHg - Liver disease (alanine aminotransferase (ALT), aspartate aminotransferase (AST) or alkaline phosphatase (ALP) greater than 3-times normal range limit) - On haemodialysis or peritoneal dialysis - Serum potassium of greater than or equal to 6.0 mmol/L - Type 1 diabetes, diabetes secondary to pancreatic disease, history of diabetic ketoacidosis - History of neoplastic disease (except for basal cell carcinoma) in the previous 1 year. - History of recurrent urinary tract infections, genital infections and/or urogenital structural abnormalities - Overt nephrotic syndrome - Acute coronary syndrome, stroke, transient ischaemic attack, or other cardiovascular event within 3 months of screening - Use of the following medications: current treatment with a SGLT2 inhibitor, current or recent (within 3 months) treatment with a glucagon-like peptide-1 (GLP1) agonist, treatment with a glucocorticoid, treatment with a non-steroidal anti-inflammatory drug (at least weekly), investigational new drug within the last 3 months - Previous bariatric surgery - Uncontrolled endocrine disorder except type 2 diabetes mellitus - Current smoker - Alcohol intake greater than or equal to 14 standard drinks per week - Women lactating, pregnant or of childbearing potential who are not willing to avoid becoming pregnant during the study - History of a psychological illness or condition such as to interfere with a person’s ability to understand the requirements of the study.
Outcome results
None listed