Understanding Diabetic Kidney Disease in Patients with Type 2 Diabetes

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to investigate the prevalence and predictive factors of diabetic nephropathy in patients with Type 2 diabetes and macroalbuminuria. A cohort of 300 patients will undergo kidney biopsies, and various biomarkers will be collected from blood, urine, and feces to analyze the transcriptome and other profiles. The goal is to enhance diagnostic accuracy and treatment precision by identifying molecular and clinical profiles that indicate risks of disease progression. Participants will be followed for 20 years to assess outcomes and refine personalized treatment approaches.

Why it matters

Who can join: the full rules

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.

Where it's running

• Aarhus Universitetshospital, Skejby
  Skejby, Aarhus, Denmark Recruiting
• Steno Diabetes Center Copenhagen
  Copenhagen, Gentofte, Denmark Recruiting
• Kristine D Schandorff
  Hillerød, Hillerød, Denmark Recruiting
• Holbæk Hospital
  Holbæk, Holbæk, Denmark Recruiting
• Rigshospitalet
  Copenhagen, København Ø, Denmark Recruiting
• Sjællands Universitetshospital, Køge
  Køge, Køge, Denmark Recruiting

Study contacts

• Study coordinator: Marie Møller
• Email: marie.moeller@regionh.dk
• Phone: +4561695364

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Assessing the impact of KidneyIntelX on managing chronic kidney disease in diabetes patients

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• Clinical decision support to help consider SGLT2 inhibitors after AKI in type 2 diabetes

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.