Efficacy of Hyperbaric Oxygen Therapy (HBOT) in New-onset Type-1 Diabetes Mellitus

Launched by ASSAF-HAROFEH MEDICAL CENTER · Jun 1, 2020

Keywords

ClinConnect Summary

This clinical trial is studying the effects of Hyperbaric Oxygen Therapy (HBOT) on children and young adults who have recently been diagnosed with Type 1 Diabetes Mellitus (T1DM). Type 1 diabetes is a condition where the body cannot produce insulin due to an autoimmune response that destroys insulin-producing cells in the pancreas. The goal of the trial is to see if HBOT can help preserve the function of these insulin-producing cells, improve blood sugar control, and reduce the amount of insulin needed by the participants.

To be eligible for this study, participants must be between the ages of 2 and 18, have been diagnosed with T1DM within the last 12 weeks, and have certain blood test results indicating they can participate safely. Throughout the 24-week study, participants will be divided into two groups: one group will receive HBOT treatment, while the other will follow standard diabetes management practices. Both groups will be monitored for changes in their blood sugar levels, insulin usage, and other health markers. This trial aims to explore a potential new treatment option for T1DM that may improve the quality of life for those living with this condition.

Gender

ALL

Eligibility 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.