The study will investigate the effect of deferoxamine on the impaired reaction to hypoxia in patients with diabetes mellitus type 1.
Conditions
Interventions
Trade Name: Desferal
Pharmaceutical Form: Powder for solution for injection/infusion
Pharmaceutical form of the placebo: Solution for infusion
Route of administration of the placebo: Intravenous use
Sponsors
Department of Endocrinology, Metabolism and Diabetes, Karolinska University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: •Patients with diabetes mellitus type 1 with a duration of the disease between 10 and 20 years •HbA1c 55-100 mmol/mol •Age 18-55 •Contraception: Female subjects must be postmenopausal, surgically sterile, or if premenopausal (and not surgically sterile), be prepared to use =1 effective method of contraception during the study and for 30 days after the last visit. Effective methods of contraception are considered to be those listed below: Double barrier method, i.e. (a) condom (male or female) or (b) diaphragm, with spermicide; or Intrauterine device; or Vasectomy (partner); or Hormonal (e.g. contraceptive pill, patch, intramuscular implant or injection); or Abstinence, if in line with the preferred and usual lifestyle of the subject. •Signed informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 30 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: •Major cardiovascular complications such as coronary heart disease, unstable or stable angina, myocardial infarction, ventricular arrhythmias, and atrial fibrillation in the last 3 months •Decompensated congestive heart failure of functional class 3-4. •Therapy with ß-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) •Definite autonomic dysfunction •History of anemia, bleeding gastric ulcer, abundant menstruation •Currently smoking •History of alcohol or drug abuse •Infections during the last month •Malignancy •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 •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 •Treatment with Prochlorperazine
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To investigate whether systemic administration of deferoxamine can reverse the impaired response to hypoxic challenge in patients with diabetes mellitus type 1.;Secondary Objective: Not applicable;Primary end point(s): Endothelial Precursor Cells number increase after intermittent hypoxia exposure;Timepoint(s) of evaluation of this end point: 24 hours after intermittent hypoxia exposure compared to baseline | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Changes in the levels of angiogenetic chemokines (SDF-1, EPO, VEGF) 2. Changes in the levels of angiogenetic and hypoxic induced genes (VEGFA, SDF-1, BPNP3, GLUT3, PDK1) 3. Changes in electrophysiological parameters important for the cardiorespiratory response: o R-R interval change o the standard deviation of the R-R interval (SDNN) o systolic and diastolic blood pressure o end-tidal carbon dioxide (CO2-et) o arterial oxygen saturation (SaO2) o breathing rate o tidal volume (Vt), minute ventilation (VE), and the ratio between Vt and inspiration time (Vt/Ti) o baroreflex sensitivity (BRS) o arterial function parameters: pulse wave velocity, augmentation index (AI), augmentation index corrected for heart rate (AI75) ;Timepoint(s) of evaluation of this end point: 1. 6 hours after intermittent hypoxia exposure compared to baseline 2. 3 and 6 hours after intermittent hypoxia exposure compared to baseline 3. Immediately after and 3 and 6 hours after intermittent hypoxia exposure compared to baseline | — |
Countries
Sweden
Contacts
Public ContactSergiu Bogdan Catrina
Department of Endocrinology, Metabolism and Diabetes, Karolinska University Hospital
Outcome results
None listed