Desferal Administration to Improve the Impaired Reaction to Hypoxia in Diabetes (DESIRED)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03085771|
Recruitment Status : Recruiting
First Posted : March 21, 2017
Last Update Posted : August 9, 2018
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
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|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.|
|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|
Placebo Comparator: Desferal treatment
Patients will be randomized (by block randomization) to Desferal (DFO) treatment.
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
- Endothelial precursor cell account (EPC) [ Time Frame: 24 hours ]The absolute amount of endothelial precursor cells in 10 ml of blood
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
|Contact: Sergiu Catrina, Ass. prof.||+46-8-517 700 firstname.lastname@example.org|
|Contact: Neda Rajamand Ekberg, M.D./Ph.D.||+email@example.com|
|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|
|Principal Investigator:||Sergiu Catrina, Ass. prof.||Karolinska University Hospital|