Using Hyperbaric Oxygen Therapy for New-onset Type 1 Diabetes
Randomized Controlled Study to Evaluate the Effect of Hyperbaric Oxygen Therapy (HBOT) on Treg-CD4+Cells, Cytokines Profile, and Beta Cells Reserve in New-onset Type-1 Diabetes Mellitus
This study is testing if Hyperbaric Oxygen Therapy can help children who have just been diagnosed with Type 1 Diabetes by improving their insulin production and blood sugar control.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 36 (estimated) |
| Ages | 8 Years to 21 Years |
| Sex | All |
| Sponsor | Assaf-Harofeh Medical Center Government |
| Locations | 2 sites (Tzrifin and 1 other locations) |
| Trial ID | NCT04412200 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the efficacy of Hyperbaric Oxygen Therapy (HBOT) in children diagnosed with new-onset Type 1 Diabetes Mellitus (T1DM) within the last 12 weeks. The study aims to evaluate the impact of HBOT on regulatory T cells, mesenchymal stem cells, and inflammatory cytokines, as well as its effect on preserving beta cell function and improving glycemic control. Participants will undergo treatment in a hyperbaric oxygen chamber while their insulin production and metabolic parameters are closely monitored. The goal is to determine if HBOT can lead to better clinical outcomes for pediatric patients with T1DM.
Who should consider this trial
Good fit: Ideal candidates are pediatric patients diagnosed with Type 1 Diabetes within the last 12 weeks who are currently on an insulin regimen.
Not a fit: Patients with significant inter-current illnesses or those requiring major surgery during the study period may not benefit from this therapy.
Why it matters
Potential benefit: If successful, this therapy could help preserve insulin production and improve metabolic control in children with new-onset T1DM.
How similar studies have performed: While the use of HBOT in diabetes management is not widely established, preliminary data suggest potential benefits, making this approach novel and exploratory.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * 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.
Where this trial is running
Tzrifin and 1 other locations
- Asaf harofe medical center — Tzrifin, Israel (Recruiting)
- Assaf Haroffeh Medical center — Zrifin, Israel (Recruiting)
Study contacts
- Study coordinator: Marianna Rachmiel
- Email: rmarianna@gmail.com
- Phone: 0537346636
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.