Metabolic Effects of the SGLT-2 Inhibitor Empagliflozin in Patients With Diabetic Nephropathy (MEDiaN)
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 2
- 试验地点
- 1
- 主要终点
- Change in ketone signature
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •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)
- •Treatment with anti-obesity drugs
- •Previous bariatric surgery or other gastrointestinal surgeries that induce chronic malabsorption
- •Treatment with systemic glucocorticoids
- •Blood dyscrasias or clinically significant anaemia (Haemoglobin < 10 g/L)
- •Medical condition likely to limit survival to less than 3 years
- •Uncontrolled thyrotoxicosis, untreated hypothyroidism
- •Any ongoing acute medical illnesses
- •Hospitalization within 1 month prior to enrolment
- •Nursing mothers
- •Pregnancy, currently trying to become pregnant, or of child-bearing potential and not practicing an acceptable method of birth control or do not plan to continue using this method throughout the study
- •Excessive alcohol intake (> 1 unit per day for women and > 2 units per day for men)
- •History of drug abuse
- •Pancreatic insulin deficiency from any cause (history of pancreatitis, pancreatic surgery)
- •Known intolerance or allergic reactions to empagliflozin or other SGLT-2 inhibitors
- •Current participation in another clinical trial, or ingestion of investigational drug in another trial within 30 days prior to enrolment.
- •Presence of any non-DN renal glomerular disease (e.g. IgA nephropathy, lupus nephritis, membranous glomerulonephritis, focal segmental glomerular sclerosis)
- •Any previous organ transplantation
- •Any factors likely to limit adherence to interventions (e.g. dementia; alcohol or substance abuse; history of unreliability in medication taking or appointment keeping; significant concerns about participation in the study from spouse, significant other or family members)
- •Failure to obtain informed consent from participant
- •Presence of postural hypotension or clinically significant dehydration (reduced skin turgor, dry oral mucosa, hypotension)
研究组 & 干预措施
Empagliflozin-treated
Oral empagliflozin tablets 10mg daily, taken for 30 days.
干预措施: Empagliflozin 10 MG (Drug)
结局指标
主要结局
Change in ketone signature
时间窗: 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
时间窗: 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
时间窗: Baseline and after 30 days of treatment with empagliflozin 10mg daily
Change in lipid metabolome signature following 30 days of empagliflozin treatment
次要结局
未报告次要终点