Treatment with Desferal to improve the impaired reaction to oxygen deficiency in patients with diabetes

Phase 1

• Conditions: The study will investigate the effect of deferoxamine on the impaired reaction to hypoxia in patients with diabetes mellitus type 1.; Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

• Registration Number: EUCTR2016-003621-41-SE
• Lead Sponsor: Department of Endocrinology, Metabolism and Diabetes, Karolinska University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-09-28
• Last Update Posted: 9 January 2017

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

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

•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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified