Metabolic Effects of the SGLT-2 Inhibitor Empagliflozin in Patients With Diabetic Nephropathy (MEDiaN)
Overview
- Phase
- Phase 3
- Intervention
- Empagliflozin 10 MG
- Conditions
- Diabetic Nephropathies
- Sponsor
- Singapore General Hospital
- Enrollment
- 2
- Locations
- 1
- Primary Endpoint
- Change in ketone signature
- Status
- Terminated
- Last Updated
- 5 years ago
Overview
Brief Summary
The MEDiaN study aims to examine the state of fuel metabolism in participants with diabetic nephropathy (DN) before and after the use of the sodium-glucose transport protein 2 inhibitor (SGLT-2i) empagliflozin. The goals of the MEDiaN study are to better understand the contribution of fuel metabolism to the development of DN, and to determine if changes to fuel metabolism can have a positive impact on this disease.
The MEDiaN study is a single-center single-arm open-label intervention study to examine the effects of empagliflozin 10mg daily taken for 30 days on fuel oxidation patterns in participants with type 2 diabetes and DN.
Detailed Description
Diabetic nephropathy (DN) is a common cause of end-stage renal disease. MEDiaN study investigators hypothesize that dysregulated mitochondrial fuel oxidation is a major driver of diabetic nephropathy. The sodium-glucose transport protein 2 inhibitor (SGLT-2i) empagliflozin has been shown to slow the progression of DN in patients with diabetes. The MEDiaN study aims to examine the state of fuel metabolism in participants with DN before and after the use of the SGLT-2i empagliflozin. The goals of the MEDiaN study are to better understand the contribution of fuel metabolism to the development of DN, and to determine if changes to fuel metabolism can have a positive impact on this disease. The MEDiaN study is a single-center single-arm open-label intervention study to examine the effects of empagliflozin 10mg daily taken for 30 days on fuel oxidation patterns in participants with type 2 diabetes and DN. The MEDiaN study plans to recruit 40 participants aged 21 to 100 years of age with type 2 diabetes mellitus and diabetic nephropathy. Participants will receive treatment with oral empagliflozin 10mg daily for 30 days. The state of fuel metabolism will be examined through metabolomics analysis of blood and urine samples before and after empagliflozin 10mg daily taken for 30 days.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- •Type 1 diabetes mellitus
- •Ketosis-prone diabetes
- •Previous diabetic ketoacidosis
- •History of Fournier's gangrene or skin and soft tissue infections of the perineum
- •Recurrent or severe urinary tract or genital mycotic infections, or history of genitourinary infection within 2 weeks prior to informed consent
- •Significant renal impairment (estimated Glomerular Filtration Rate \< 45 ml/min/1.73m2\*\*)
- •Dialysis or kidney transplant
- •Renal artery stenosis
- •Alanine aminotransferase or aspartate aminotransferase above 3x upper limit of normal
- •Significant change in weight (≥10% in the preceding 6 months)
Arms & Interventions
Empagliflozin-treated
Oral empagliflozin tablets 10mg daily, taken for 30 days.
Intervention: Empagliflozin 10 MG
Outcomes
Primary Outcomes
Change in ketone signature
Time Frame: Baseline and after 30 days of treatment with empagliflozin 10mg daily
Change in ketone signature following 30 days of empagliflozin treatment
Change in amino acid metabolome signature
Time Frame: Baseline and after 30 days of treatment with empagliflozin 10mg daily
Change in amino acid metabolome signature following 30 days of empagliflozin treatment
Change in lipid metabolome signature
Time Frame: Baseline and after 30 days of treatment with empagliflozin 10mg daily
Change in lipid metabolome signature following 30 days of empagliflozin treatment