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

NCT04412200 | Recruiting

• 1 other identifier: 0290-19-ASF
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 2

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 C-peptide) may result in meaningful clinical benefits including lower rates of complications, improved metabolic control, reduced insulin injections, and improved quality of life. Objective:

1. 1.To assess the effect of HBOT on Treg, mesanchymal stem cells, and pro-inflammatory cytokines ratio in pediatric population with new-onset T1DM Secondary
2. 2.To assess the effect of HBOT on beta cell reserve in pediatric population with new-onset T1DM
3. 3.To assess the effect of HBOT on glycemic control parameters including time in range, HbA1c and daily insulin dose, in the pediatric population with new-onset T1DM
4. 4.Immune system parameters will be assessed by blood levels of T-regulatory cells, diabetes auto-antibody and inflammatory cytokines.
5. 5.Pancreatic β cells function will be evaluated by measurements of blood area under the curve (AUC) C-peptide, peak C-peptide, and basal proinsulin/c-peptide ratio.
6. 6.glycemic control parameters will be evaluated by CGMS data regarding time spent in glycemic range, hypoglycemic and hyperglycemic ranges, total daily dose of insulin according to CLIPSULIN , and blood tests for glycated hemoglobin (HbA1c).
7. 7.Microbiome changes will be assessed by stool samples.

Conditions

T1DM

Keywords

Hyperbaric chamber; autoimmune disease; inflammation; recent onset autoimmune diabetes; beta cells; diabetes mellitus type 1; pediatrics

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• insulin daily dose (IDD) unit/kg/d

  24 weeks

• C-max of stimulated C peptide

  24 weeks

• AUC of stimulated C peptide

  24 weeks

Study Arms (2)

Hyperbaric oxygen chamber Arm

EXPERIMENTAL

Patients will be randomized at a ratio of 2:1, to hyperbaric chamber (100% oxygen at 2 ATA)

Device: Hyperbaric oxygen chamber (HBOC)

Control arm

NO INTERVENTION

control group will receive common practice management.

Interventions

Hyperbaric oxygen chamber (HBOC) DEVICE

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,

Hyperbaric oxygen chamber Arm

Eligibility Criteria

• Age: 8 Years - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assaf-Harofeh Medical Center: lead

Study Sites (2)

Asaf harofe medical center

Tzrifin, 70300, Israel

RECRUITING

Assaf Haroffeh Medical center

Zrifin, 70300, Israel

RECRUITING

MeSH Terms

Conditions

Autoimmune Diseases; Inflammation; Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Immune System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Central Study Contacts

Marianna Rachmiel

CONTACT

0537346636; rmarianna@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 29, 2020
• First Posted: June 2, 2020
• Study Start: June 1, 2020
• Primary Completion: November 1, 2024
• Study Completion: May 1, 2026
• Last Updated: September 21, 2022

Record last verified: 2022-09

Locations

IL (2)