Desferal Administration to Improve the Impaired Reaction to Hypoxia in Diabetes

• Status: Recruiting
• Trial end date: 2022-12-12
• Target enrollment: 0
• Participant gender: All

Summary

The general aim of this study is to investigate the influence of systemic administration of Desferal (Deferoxamine [DFO]) on the response to hypoxic challenge in patients with diabetes mellitus (DM).

The investigation will elucidate if DFO can restore:

• the impaired angiogenetic response to hypoxia in patients with type 1 DM.

• the disturbed respiratory and cardiovascular regulation in response to hypoxia in patients with DM type 1

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Karolinska University Hospital
• Treatments: Deferoxamine

Criteria

Inclusion Criteria:

1. Patients with type1 diabetes with a duration of the disease between 10-20 years (HbA1c ≥ 55 mmol/mol)

2. Age 18-55

3. Diabetes duration 5-40 years

4. Contraception: Female subjects must be postmenopausal, surgically sterile, or if premenopausal (and not surgically sterile), be prepared to use more than 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:

1. Double barrier method, i.e. (a) condom (male or female) or (b) diaphragm, with spermicide; or

2. Intrauterine device; or

3. Vasectomy (partner); or

4. Hormonal (e.g. contraceptive pill, patch, intramuscular implant or injection); or

5. Abstinence, if in line with the preferred and usual lifestyle of the subject.

5. Signed informed consent

Exclusion Criteria:

1. Smoking

2. Infections during the last month

3. Major cardiovascular complications such as coronary heart disease, unstable or stable angina, myocardial infarction, ventricular arrhythmias, and atrial fibrillation in the last 3 months

4. Decompensated congestive heart failure or functional class 3-4.

5. therapy with beta-blockers

6. severe hypertension (180 mmHg systolic or 110 mmHg diastolic blood pressure

7. proliferative retinopathy.

8. Sign for peripheral diabetic neuropathy (decreased/absent sensitivity to 10 g monofilament, vibration, plantar reflex)

9. definite autonomic dysfunction

10. HbA1c > 100 mmol/l

11. Any concomitant disease or condition that may interfere with the possibility for the patient to comply with or complete the study protocol

12. Malignancy

13. History of alcohol or drug abuse

14. Participant in another ongoing pharmacological study

15. If female: plans to become pregnant, known pregnancy or a positive urine pregnancy test (confirmed by a positive serum pregnancy test), or lactating

16. Unwillingness to participate following oral and written information

17. 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

18. History of anemia, bleeding gastric ulcer, abundant menstruation

19. Treatment with prochlorperazine