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Desferal Administration to Improve the Impaired Reaction to Hypoxia in Diabetes (DESIRED)

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ClinicalTrials.gov Identifier: NCT03085771
Recruitment Status : Recruiting
First Posted : March 21, 2017
Last Update Posted : August 9, 2018
Sponsor:
Information provided by (Responsible Party):
Sergiu Catrina, Karolinska University Hospital

Brief 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

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 1 Drug: desferal Drug: Isotonic saline Phase 2

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: This is a randomised, double-blind, placebo-controlled, cross-over, single center study of patients with diabetes mellitus type 1 without chronic complications.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: This is a double-blind study.
Primary Purpose: Treatment
Official Title: Desferal Administration to Improve the Impaired Reaction to Hypoxia in Diabetes
Actual Study Start Date : January 1, 2017
Estimated Primary Completion Date : December 12, 2020
Estimated Study Completion Date : December 12, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Desferal treatment
Patients will be randomized (by block randomization) to Desferal (DFO) treatment.
Drug: desferal
It is a blinded randomized cross-over study that investigates the efficacy of DFO (50mg/kg) given i.v before intermittent hypoxia (IH) to improve the cardiorespiratory and angiogenetic response in patients with diabetes.
Other Name: deferoxamine

Placebo Comparator: Isotonic saline treatment
Patients will be randomized (by block randomization) to isotonic saline treatment.
Drug: Isotonic saline
It is a blinded randomized cross-over study that investigates the efficacy of isotonic saline given i.v before intermittent hypoxia (IH) to improve the cardiorespiratory and angiogenetic response in patients with diabetes.
Other Name: Isotonic solution




Primary Outcome Measures :
  1. Endothelial precursor cell account (EPC) [ Time Frame: 24 hours ]
    The absolute amount of endothelial precursor cells in 10 ml of blood



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03085771


Contacts
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Contact: Sergiu Catrina, Ass. prof. +46-8-517 700 00 sergiu.catrina@ki.se
Contact: Neda Rajamand Ekberg, M.D./Ph.D. +46-8-51772769 neda.ekberg@ki.se

Locations
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Sweden
Karolinska University Hospital Recruiting
Stockholm, Sweden, 17176
Contact: Sergiu Catrina, ass prof MD    +46-8-51770000    sergiu-bogdan.Catrina@ki.se   
Contact: Neda Ekberg, PhD, MD    +46-(0)8 51775449    Neda.Ekberg@ki.se   
Sponsors and Collaborators
Karolinska University Hospital
Investigators
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Principal Investigator: Sergiu Catrina, Ass. prof. Karolinska University Hospital

Publications:

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Responsible Party: Sergiu Catrina, Senior consultant / associated professor, Karolinska University Hospital
ClinicalTrials.gov Identifier: NCT03085771     History of Changes
Other Study ID Numbers: 2016/1925-31
First Posted: March 21, 2017    Key Record Dates
Last Update Posted: August 9, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 1
Hypoxia
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Autoimmune Diseases
Immune System Diseases
Deferoxamine
Siderophores
Iron Chelating Agents
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action