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Clinical Trial NCT04412200 for T1DM is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.
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Efficacy of Hyperbaric Oxygen Therapy (HBOT) in New-onset Type-1 Diabetes Mellitus 36 Microbiome Randomized Pediatric Dietary

Recruiting
Clinical Trial NCT04412200 is an interventional study for T1DM that is recruiting. It started on 1 June 2020 with plans to enroll 36 participants. Led by Assaf-Harofeh Medical Center, it is expected to complete by 1 May 2026. The latest data from ClinicalTrials.gov was last updated on 21 September 2022.
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 according to glucose measurements and dietary restrictions, leading to short and long term complications. Current data demonstrate that even modest preservation of β-cell function and endogenous production of insulin (marked by...Show More
Official Title

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

Conditions
T1DM
Other Study IDs
  • 0290-19-ASF
NCT ID Number
NCT04412200
Start Date (Actual)
2020-06-01
Last Update Posted
2022-09-21
Completion Date (Estimated)
2026-05
Enrollment (Estimated)
36
Study Type
Interventional
PHASE
N/A
Status
Recruiting
Keywords
Hyperbaric chamber
autoimmune disease
inflammation
recent onset autoimmune diabetes
beta cells
diabetes mellitus type 1
pediatrics
Primary Purpose
Treatment
Design Allocation
Randomized
Interventional Model
Parallel
Masking
None (Open Label)
Arms / Interventions
Participant Group/ArmIntervention/Treatment
ExperimentalHyperbaric oxygen chamber Arm
Patients will be randomized at a ratio of 2:1, to hyperbaric chamber (100% oxygen at 2 ATA)
Hyperbaric oxygen chamber (HBOC)
HBOC group will receive 100% oxygen at 2 ATA for 90 min with 5 min air breaks every 20 min at each session. Intensive management period includes 60 daily sessions, 5 days per week within 12 weeks,
No InterventionControl arm
control group will receive common practice management.
N/A
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Regulatory T cells and B cells
24 weeks
Cytokine secretion
by stimulated peripheral blood mononuclear cells cultured with LPS or PHA for 72 hours, and in supernatant will be measured by relevant commercial ELISA kits
24 weeks
Secondary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
insulin daily dose (IDD) unit/kg/d
Difference between groups in achievement of glycemic targets according to ITDD, with a lower ITDD. assessed by: mean and SD of glucose, CV, time spent in range \>70%, and time spent at hypoglycemic range \< 1% at end of treatment periods, IDD according to weight.
24 weeks
C-max of stimulated C peptide
Difference between treatment groups (HBOT/SHBC) in change of β cell function (measured by C-max of stimulated C peptide) from screening to end of study (24 weeks).
24 weeks
AUC of stimulated C peptide
Difference between treatment groups (HBOT/SHBC) in change of β cell function (measured by AUC of stimulated C peptide) from screening to end of study (24 weeks).
24 weeks
Participation Assistant
Eligibility Criteria

Eligible Ages
Child, Adult
Minimum Age
8 Years
Eligible Sexes
All
  • 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

  • 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.
Assaf-Harofeh Medical Center logoAssaf-Harofeh Medical Center
Study Central Contact
Contact: Marianna Rachmiel, 0537346636, [email protected]
2 Study Locations in 1 Countries
Asaf harofe medical center, Tzrifin, 70300, Israel
Avital Leshem, Contact, 0528303012, [email protected]
Recruiting
Assaf Haroffeh Medical center, Zrifin, 70300, Israel
Marianna Rachmiel, md, Contact, 972-8-9542007, [email protected]
Recruiting