Comparison of Once Versus Twice Daily Prednisolone Administration on Blood Glucose Control in Patients with ANCA-Associated Vasculitis

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What is this study about?

This study focuses on patients with ANCA-associated vasculitis, a condition where the body’s immune system attacks its own blood vessels, and rapid-progressive glomerulonephritis, which affects kidney function. The study uses prednisolone, a corticosteroid medication that helps reduce inflammation and suppress the immune system response.

The purpose of this research is to determine if taking corticosteroid medication twice per day, instead of once daily, leads to better control of blood sugar levels. During the study, participants will receive Aprednislon tablets and will wear a special device that continuously monitors their blood sugar levels. The total treatment period lasts 14 days.

The study will track how long blood sugar levels stay within a healthy range throughout the day. Additional measurements will include various blood tests to monitor the effectiveness of treatment and its impact on overall health. Participants will also complete questionnaires about their quality of life during the study period.

1 Initial medication phase

You will receive Aprednislon tablets at a dose of 1mg per kilogram of your body weight

The medication will be administered in two different ways during the study: once daily or split into two doses per day

The tablets should be taken by mouth as prescribed

2 Blood glucose monitoring

A continuous glucose monitoring (CGM) device will be attached to monitor your blood sugar levels

The device will track your blood glucose values throughout the day and night

Target blood sugar range is between 70-180 mg/dl

Additional blood glucose measurements will be taken before meals and at bedtime

3 Insulin treatment

If needed, you will receive insulin therapy to manage your blood sugar levels

The number of insulin injections per day will be determined based on your blood glucose readings

4 Medical assessments

Regular blood tests will measure various health markers including HbA1c (long-term blood sugar level)

Kidney function tests will be performed to check creatinine levels and filtration rate

Urine tests will check for protein levels and other markers

Your overall disease activity will be measured using the Birmingham Vasculitis Score

5 Quality of life assessment

You will complete two questionnaires: SF-36 and KDQOL

These forms will help assess how the treatment affects your daily life and well-being

Who Can Join the Study?

  • Patient must provide written consent to participate in the study after receiving a detailed explanation
  • Both men and women can participate
  • Must have either a new diagnosis of ANCA-associated vasculitis (a condition where the immune system attacks blood vessels) or experiencing a relapse of previously diagnosed ANCA vasculitis
  • Must be between 18 and 80 years old at the time of tissue sampling (biopsy)
  • Must be currently taking Aprednislon (a corticosteroid medication) at a dose of 1mg per kilogram of body weight
  • Must be willing to wear a CGM system (Continuous Glucose Monitoring device – a small sensor that continuously measures blood sugar levels) throughout the study duration
  • Must be willing to receive insulin therapy if needed during the study (insulin is a hormone that helps control blood sugar levels)

Who Cannot Join the Study?

  • Patients under 18 years old or over 65 years old
  • Patients with known allergies or hypersensitivity to cortisone or similar medications
  • Patients with uncontrolled diabetes or severe blood sugar management issues
  • Patients with active infections that require immediate treatment
  • Pregnant or breastfeeding women
  • Patients currently participating in other clinical trials
  • Patients with severe kidney dysfunction (other than that related to ANCA-associated vasculitis or RPGN)
  • Patients unable to follow the study protocol or attend scheduled visits
  • Patients with psychiatric conditions that could interfere with the study compliance
  • Patients taking medications that could interact with the study treatment
  • Patients with uncontrolled hypertension (high blood pressure)
  • Patients with history of gastrointestinal bleeding or active ulcers
  • Patients with severe liver disease

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

Site Name City Country Status
Medical University Of Graz Graz Austria

Other Sites

No sites found in this category

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Austria Austria
Recruiting
15.09.2019

Trial locations

Investigated drugs:

Corticosteroids are medications that mimic the effects of hormones that your body naturally produces in your adrenal glands. In this study, they are used to treat ANCA-vasculitis, which is a condition where blood vessels become inflamed. These medications help reduce inflammation and suppress the immune system. The study compares how taking the same total amount of corticosteroids either once per day or split into two doses affects blood sugar levels in patients.

Anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis – A group of autoimmune conditions that cause inflammation of small blood vessels throughout the body. This disease occurs when the immune system mistakenly attacks the body’s own blood vessels, leading to inflammation and damage. It can affect multiple organs, including kidneys, lungs, and skin. The condition typically develops gradually, with symptoms appearing over several weeks or months.

Rapid-progressive glomerulonephritis (RPGN) – A kidney disease characterized by swift deterioration of kidney function due to severe inflammation in the glomeruli, which are the kidney’s filtering units. The condition develops rapidly over days to weeks, causing inflammation and damage to the kidneys’ filtering system. The disease can occur on its own or as part of other autoimmune conditions. It leads to the formation of crescents in the glomeruli, which interferes with the normal filtering process of the kidneys.

Trial ID:
2024-516141-39-00
Trial Phase:
Human Pharmacology (Phase I) – Other

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