Status:
RECRUITING
Efficacy of Hyperbaric Oxygen Therapy (HBOT) in New-onset Type-1 Diabetes Mellitus
Lead Sponsor:
Assaf-Harofeh Medical Center
Conditions:
T1DM
Eligibility:
All Genders
8-21 years
Phase:
NA
Brief Summary
Type 1 Diabetes Mellitus (T1DM) is caused by an autoimmune process that progressively destroys the pancreatic β-cells, and leads to dependence on multiple daily insulin subcutaneous injections accordi...
Eligibility Criteria
Inclusion
- Parent/guardian willing and able to sign an informed consent
- Participant willing and able to sign an assent
- Diagnosed with type 1 diabetes within 12 weeks prior to randomization
- Treated with insulin by basal-bolus regimen (injections or pump)
- Peak C-peptide ≥ 0.2 pmol/ml
- At least 1 positive diabetes auto-antibody
- No significant abnormalities in hematology and serum chemistry according to the investigator's judgment, taking into consideration the potential effects of the diabetic illness
- No significant abnormalities in urinalysis, taking into considerations the potential effects of the diabetic illness
- For females of child bearing potential: whose screening pregnancy test is negative and who are using contraceptive methods deemed reliable by the investigator
Exclusion
- Planned major surgery within the study period
- Clinically significant inter-current illnesses, including (but not limited to): lung, cardiac, hepatic, renal, eye, neurological, hematological, neoplastic, immunological, skeletal or other, that in the opinion of the investigator, could interfere with the safety, compliance or other aspects of this study. Patients with well-controlled, chronic diseases could be possibly included after consultation with the investigator at site.
- Presence of psychiatric/ mental disorder or any other medical disorder which might impair the patient's ability to give informed consent or to comply with the requirements of the study protocol
- Participation in another interventional clinical trial
- Inability to attend scheduled clinic visits and/or comply with the study protocol
- Current use of any medication known to influence glucose tolerance (e.g., β-blockers, angiotensin-converting enzyme inhibitors, interferons, quinidine anti-malarial drugs, lithium, niacin, metformin, sulfonylureas, glinides, thiazolidinediones, exenatide, liraglutide, DPP-IV inhibitors or amylin).
- Lung disease, middle ear disease, inner ear disease, history of epileptic seizures or any other condition that based on the physician clinical judgment is not suitable to get the hyperbaric treatment.
- Any other factor that, in the opinion of the investigator, would prevent the patient form complying with the requirements of the protocol.
Key Trial Info
Start Date :
June 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2026
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT04412200
Start Date
June 1 2020
End Date
May 1 2026
Last Update
September 21 2022
Active Locations (2)
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1
Asaf harofe medical center
Tzrifin, Israel, 70300
2
Assaf Haroffeh Medical center
Zrifin, Israel, 70300