Study on Deferoxamine to Improve Hypoxia Response in Type 1 Diabetes Patients

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What is this study about?

This clinical trial is focused on studying the effects of a medication called Desferal on people with Type 1 Diabetes. Type 1 Diabetes is a condition where the body does not produce insulin, a hormone needed to control blood sugar levels. The study aims to see if Desferal can help improve how patients with this condition respond to low oxygen levels, a situation known as hypoxia.

Participants in the study will receive Desferal, which is given as an injection or infusion, meaning it is administered directly into the bloodstream. The study is designed to compare the effects of Desferal with a placebo, which is a substance with no active medication. This comparison helps researchers understand the true effects of Desferal. The study will follow a cross-over design, meaning participants will receive both Desferal and the placebo at different times during the study.

The main goal of the study is to determine if Desferal can improve the body’s response to hypoxia in patients with Type 1 Diabetes. This involves monitoring changes in certain cells and substances in the blood that are related to blood vessel growth and oxygen levels. The study will also look at various heart and lung functions to see how they are affected by the treatment. The trial is expected to continue until the end of 2026.

1 introduction to the trial

Upon joining the study, the patient will receive an overview of the trial’s purpose, which is to assess the effect of deferoxamine on the body’s response to low oxygen levels in individuals with type 1 diabetes.

The patient will be informed about the study’s design, which is randomised, double-blind, placebo-controlled, and cross-over, meaning that participants will receive both the active treatment and a placebo at different times.

2 medication administration

The patient will receive Desferal (deferoxamine mesilate) as a solution for injection or infusion. This medication will be administered intravenously.

The dosage and frequency of administration will be determined by the study protocol, ensuring the patient receives the correct amount to evaluate the treatment’s effectiveness.

3 monitoring and assessments

Throughout the trial, the patient will undergo regular monitoring to assess the number of endothelial precursor cells in the blood after exposure to intermittent low oxygen levels.

Additional assessments will include measuring changes in specific proteins and genes related to blood vessel growth and oxygen response, as well as evaluating heart and lung function through various physiological parameters.

4 completion of the trial

The trial is expected to conclude by December 26, 2026. Upon completion, the patient will have a final assessment to gather all necessary data.

The patient will be informed of the study’s outcomes and any potential implications for future treatment options for type 1 diabetes.

Who Can Join the Study?

Patients must have diabetes mellitus type 1, which is a condition where the body cannot produce insulin, for a duration between 5 and 40 years.
Their HbA1c levels, which is a measure of blood sugar control over the past 2 to 3 months, should be between 55 and 100 mmol/mol.
They should be between the ages of 18 and 55.
They must have a normal ECG result, which is a test that checks for problems with the electrical activity of the heart, showing no signs of significant heart disorders.
Female participants must either be postmenopausal, surgically sterile, or if they are premenopausal and not surgically sterile, they must use a highly effective method of contraception during the study and for 30 days after the last visit. These methods include hormonal contraception that stops ovulation, an intrauterine device, a hormone-releasing system, having their fallopian tubes blocked, having a partner who has had a vasectomy, or practicing sexual abstinence.
Participants must provide signed informed consent, which means they agree to participate in the study after being informed about all aspects of the trial.

Who Cannot Join the Study?

Patients who do not have diabetes mellitus type 1 cannot participate. This is a condition where the body does not produce insulin, a hormone needed to control blood sugar levels.
Patients who are not experiencing issues with their body’s reaction to hypoxia cannot participate. Hypoxia is a condition where the body or a part of the body is not getting enough oxygen.
Patients who are not within the specified age range for the study cannot participate. The study is looking for participants within a certain age group.
Patients who are part of a vulnerable population cannot participate. This means people who might need special protection or care.

Where you can join this trial?

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Other Sites

Site Name	City	Country	Status
Karolinska University Hospital	Solna	Sweden

Trial status

Country	Status	Recruitment Start
Sweden	Recruiting	01.11.2016

Trial locations

Investigated drugs:

Deferoxamine Mesilate

Desferal: This medication is used in the trial to see if it can help improve how patients with type 1 diabetes respond to low oxygen levels. It is being tested to understand if it can make the body react better to situations where there is not enough oxygen, which can be a problem for people with diabetes.

Investigated diseases:

Diabetes Mellitus Type 1 – This is a chronic condition where the pancreas produces little or no insulin, a hormone needed to allow sugar (glucose) to enter cells to produce energy. It typically appears in childhood or adolescence, but it can develop in adults. The disease progresses as the immune system mistakenly attacks and destroys insulin-producing cells in the pancreas. Over time, this leads to high blood sugar levels, which can cause various symptoms such as increased thirst, frequent urination, hunger, fatigue, and blurred vision. If not managed, it can lead to complications affecting the heart, blood vessels, nerves, eyes, and kidneys. Regular monitoring and management of blood sugar levels are crucial to managing the disease.

Trial ID:

2024-519562-48-00

Protocol code:

DESIRED

NCT ID:

NCT03085771

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on Deferoxamine to Improve Hypoxia Response in Type 1 Diabetes Patients

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