RecruitingRare disease

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

Verified siteRegistered drugNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

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.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 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
Step 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
Step 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
Step 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
Step 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 trial?

7 criteria

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 trial?

13 criteria

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

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Verified sites

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Medical University Of Graz
Verified
Graz, Austria

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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.

Prednisolone

What is already known about the treatment

Corticosteroids – A class of steroid hormones administered either orally or intravenously that are used to treat various inflammatory conditions, particularly in ANCA-associated vasculitis and rapid-progressive glomerulonephritis. These medications work by suppressing the immune system and reducing inflammation by binding to specific receptors in cells, thereby decreasing the production of inflammatory substances in the body. Corticosteroids belong to the glucocorticoid class of medications and are widely recognized in medical literature as a primary treatment for autoimmune and inflammatory conditions, though they require careful monitoring due to their effects on blood glucose levels and other potential side effects.

Investigated diseases

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.