Diabetic Nephropathy in People With Diabetes. Prevalence and Predictive Factors

Launched by HERLEV HOSPITAL · Jun 1, 2021

Keywords

ClinConnect Summary

This clinical trial is investigating how common kidney problems are in people with type 2 diabetes and what factors might predict these issues. Specifically, the study will involve 300 adults who have type 2 diabetes and high levels of protein in their urine, a condition known as macroalbuminuria. Researchers will collect kidney tissue samples through a biopsy, along with blood, urine, and stool samples, to analyze them for specific markers. The goal is to better understand kidney disease in diabetes, which may lead to more personalized treatment options based on individual risk factors.

To participate, you need to be at least 18 years old and diagnosed with type 2 diabetes, with a certain level of kidney function and protein in your urine. Some people may not be eligible if they have certain health conditions that could complicate the kidney biopsy or if they have had a kidney transplant. If you join the study, you can expect to undergo a kidney biopsy and provide various samples, helping researchers learn more about managing kidney health in diabetes. Your involvement could contribute to future treatments that could benefit many others facing similar challenges.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Age ≥ 18 years
• • Written informed consent
• • Diagnosis with T2DM according to the American diabetes Association (20)
• • eGFR \>30 mL/min/1.73 m2 (maximum six months old)
• • urine-albumin/creatinine-ratio (uACR) \> 700 mg/g or 24 hours urine albumin \>700 mg on more than one measurement
• Exclusion Criteria:
• • Signs of acute kidney failure according to the KDIGO classification (21) at the time for kidney biopsy or the last 6 months before kidney biopsy
• * Factors that increases the risk of complications due to kidney biopsy:
• • Hemoglobin \< 6 mmol/L
• • INR \>1,4 at the time for biopsy
• • Platelet count \< 100 x 109/l
• • Uncontrolled high blood pressure (defined as systolic blood pressure \> 160 mmHg and/or diastolic blood pressure \> 100 mmHg)
• • Only one functioning kidney
• • Evidence of urinary tract obstruction or hydronephrosis at the time of biopsy
• • Multiple bilateral kidney cysts
• • Kidney infection, peri-renal infection, or cutaneous infection that overlies the kidney at time for biopsy
• • Unwilling to receive blood transfusion
• • Unable to lie flat in bed six hours after biopsy
• • Any other contra-indications for percutaneous kidney biopsy according to local clinical guidelines
• • Unable to understand written and oral information
• • Kidney transplant recipient
• • Previous medical kidney biopsy
• • Women who are pregnant or planning to become pregnant before the kidney biopsy is performed
• • Treatment with Marcoumar (all other anticoagulants are accepted)
• • High thromboembolic risk combined with held in anticoagulation therapy according to the report "Perioperative regulation of antithrombotic treatment" (PRAB) (22)
• • mechanical heart valve
• • atrial fibrillation AND CHA2DS2-VASc\> 5 and/or stroke within the last three months
• • recurrent venous thromboembolism OR venous thromboembolism within the last three months
• • less than 6 weeks after uncomplicated Acute Coronary Syndrome (ACS) with or without revascularization (Percutaneous Coronary Intervention (PCI)) with Bare Metal Stents (BMS) or Coronary Artery Bypass Grafting (CABG))
• • less than 3 months after uncomplicated ACS with revascularization (PCI with Drug Eluting Stent (DES))
• • less than 9-12 months after complicated ACS (e.g. reinfarction or stent thrombosis)
• • less than 1 month after revascularization in individuals with stable Coronary Artery Disease (CAD) (PCI with BMS or CABG)
• • less than 3 months after revascularization in individuals with stable CAD (PCI with DES)
• • less than 3 months after stroke, or Transient Ischemic Attack (TIA)
• • Inability to withdraw nonsteroidal anti-inflammatory drugs (NSAID) 7 days before biopsy
• • If a participant meets one or more exclusion criteria, that are reversible, the participant can be rescreened later on, to evaluate whether or not the participant now is qualified for participation.