Tests deferoxamine for weak body response to low oxygen in type 1 diabetes
Tests deferoxamine against placebo in adults with type 1 diabetes.
Plain-language title generated from the registry record
Registry title: Desferal administration to improve the impaired reaction to hypoxia in diabetes (DESIRED) - A randomised, double-blind, placebo-controlled, cross-over study
Key facts
- Where
- Solna, SwedenSee the site
- Phase
- Phase 2
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 64 years old?
Source: NCT03085771, who can take part
Where in Sweden
- Karolinska University HospitalSolna, SwedenTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Karolinska University Hospital
- Trial code
- NCT03085771EU 2024-519562-48-00
- Record updated
- 13 January 2025
- Original description
To investigate whether systemic administration of deferoxamine can improve the response to hypoxic challenge in patients with diabetes mellitus type 1.Read full original descriptionShow less
Desferal administration to improve the impaired reaction to hypoxia in diabetes (DESIRED) - A randomised, double-blind, placebo-controlled, cross-over study.
To investigate whether systemic administration of deferoxamine can improve the response to hypoxic challenge in patients with diabetes mellitus type 1.
Inclusion: 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.
Exclusion: Any concomitant disease or condition that may interfere with the possibility for the subject to comply with or complete the study protocol; Treatment with Prochlorperazine; Therapy with β-blockers; 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; History of anemia, bleeding gastric ulcer, abundant menstruation; 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; 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; History of asthma or chronic obstructive pulmonary disease; Severe hypertension (≥180 mmHg systolic or ≥110 mmHg diastolic blood pressure); If female: plans to become pregnant, known pregnancy or a positive urine pregnancy test (confirmed by a positive serum pregnancy test), or lactating; 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); Definite cardiovascular autonomic dysfunction; Currently smoking; Participant in another ongoing pharmacological study; Unwillingness to participate following oral and written information; Proliferative retinopathy; Sign for peripheric diabetic neuropathy (decreased/absent sensitivity to 10 g monofilament, vibration, plantar reflex).