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Desferal administration to improve the impaired reaction to hypoxia in diabetes (DESIRED) - A randomised, double-blind, placebo-controlled, cross-over study
EU CTIS ID: 2024-519562-48-00
What this study is testing
To investigate whether systemic administration of deferoxamine can improve the response to hypoxic challenge in patients with diabetes mellitus type 1.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Patients with diabetes mellitus type 1 with a duration of the disease between 5 and 40 years
- HbA1c 55-100 mmol/mol
- Age 18-55
- Normal ECG result, showing no signs of significant cardiac disorders
- Contraception: Female subjects must be postmenopausal, surgically sterile, or, if premenopausal (and not surgically sterile), use a highly effective method of contraception during the study and for 30 days after the last visit. Highly effective methods of contraception are considered to be those listed below: combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation; or progestogen-only hormonal contraception associated with inhibition of ovulation; or intrauterine device; or intrauterine hormonereleasing system; or bilateral tubal occlusion; or vasectomised partner; or sexual abstinence
- Signed informed consent
You likely can't join if
- Major cardiovascular complications such as coronary heart disease, unstable or stable angina, myocardial infarction, ventricular XML File Identifier: GVRsEn/+aiS1r4rVgVsURkq36HM= Page 11/21 arrhythmias, and atrial fibrillation in the last 3 months
- Definite cardiovascular autonomic dysfunction
- History of anemia, bleeding gastric ulcer, abundant menstruation
- Currently smoking
- History of alcohol or drug abuse
- Infections that necessitated antibiotic therapy during the last month
See the full eligibility criteria
Who can join
- Patients with diabetes mellitus type 1 with a duration of the disease between 5 and 40 years
- HbA1c 55-100 mmol/mol
- Age 18-55
- Normal ECG result, showing no signs of significant cardiac disorders
- Contraception: Female subjects must be postmenopausal, surgically sterile, or, if premenopausal (and not surgically sterile), use a highly effective method of contraception during the study and for 30 days after the last visit. Highly effective methods of contraception are considered to be those listed below: combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation; or progestogen-only hormonal contraception associated with inhibition of ovulation; or intrauterine device; or intrauterine hormonereleasing system; or bilateral tubal occlusion; or vasectomised partner; or sexual abstinence
- Signed informed consent
What rules you out
- Major cardiovascular complications such as coronary heart disease, unstable or stable angina, myocardial infarction, ventricular XML File Identifier: GVRsEn/+aiS1r4rVgVsURkq36HM= Page 11/21 arrhythmias, and atrial fibrillation in the last 3 months
- Definite cardiovascular autonomic dysfunction
- History of anemia, bleeding gastric ulcer, abundant menstruation
- Currently smoking
- History of alcohol or drug abuse
- Infections that necessitated antibiotic therapy during the last month
- Malignancy (with the exception of in situ cancer) that has been declared treated within the last 5 years
- Participant in another ongoing pharmacological study
- Unwillingness to participate following oral and written information
- If female: plans to become pregnant, known pregnancy or a positive urine pregnancy test (confirmed by a positive serum pregnancy test), or lactating
- Any concomitant disease or condition that may interfere with the possibility for the subject to comply with or complete the study protocol
- Congestive heart failure (as suggested by anamnesis and by a value of NT-proBNP <155 ng/ml)
- Subjects with any other severe acute or chronic medical or psychiatric condition that make the subject inappropriate for the study in the judgment of the Investigator
- Known hypersensitivity to the active substance
- Treatment with Prochlorperazine
- History of asthma or chronic obstructive pulmonary disease
- Renal insufficiency (cystatin clearance <60 ml/min)
- Liver disease (ALAT/ASAT values >2 times the normal levels or INR > 1,2 or albumin levels < 36 g/ l or total bilirubin < 26 micromol/l or gamma GT <2 mikrokat/l)
- Therapy with β-blockers
- Severe hypertension (≥180 mmHg systolic or ≥110 mmHg diastolic blood pressure)
- Proliferative retinopathy
- Sign for peripheric diabetic neuropathy (decreased/absent sensitivity to 10 g monofilament, vibration, plantar reflex)
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.