Acute Hyperbaric Oxygen Treatment Increases Hepatic Insulin Sensitivity and Muscle Reactive Oxygen Species in T2D

NCT04219215 | Completed

• 1 other identifier: HBO
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

Diabetes mellitus type 2 (T2D) is characterized by insulin resistance of liver and skeletal muscle, which is at least partly due to impaired muscle mitochondrial function. Long-term HBO therapy, as applied for treating the diabetic foot syndrome, has been shown to improve blood glucose concentrations. To study the underlying mechanisms, we want to examin the short-term effect of HBO treatment on insulin sensitivity and mitochondrial oxidative capacity and production of reactive oxygen species (ROS) in a randomized, double blinded, placebo-controlled cross-over trial.

Conditions

Type 2-diabetes

Outcome Measures

Primary Outcomes (1)

• Change in rate of glucose disappearance

  measurement of whole body insulin sensitivity with hyperinsulinamic euglycemic clamp test

  12 months

Study Arms (2)

Hyperbaric oxygenation

EXPERIMENTAL

Patients with T2D receive an 2 hour treatment with 100 % oxygen in a hyperbaric chamber

Device: 100% O2 in oxygen chamber; Device: 21% O2 in oxygen chamber

Ambient Air

EXPERIMENTAL

Patients with T2D receive an 2 hour treatment with 21% oxygen in a hyperbaric chamber

Device: 100% O2 in oxygen chamber; Device: 21% O2 in oxygen chamber

Interventions

100% O2 in oxygen chamber DEVICE

Application of 100% O2 in an hyperbaric oxygen chamber

Ambient Air; Hyperbaric oxygenation

21% O2 in oxygen chamber DEVICE

Application of ambient air (21% O2) in an hyperbaric oxygen chamber

Ambient Air; Hyperbaric oxygenation

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 and ≤ 75 years
• Type 2 diabetes
• HbA1c ≥ 6 and ≤ 9%
• BMI ≤ 35 kg / m2

You may not qualify if:

• Treatment with thiazolidinedione in the last 6 months
• Uncontrolled hyperglycemia (FPG ≥ 240 mg / dl)
• vitamin supplement (washing out at least 4 weeks)
• Patients requiring revascularization
• Serum CRP ≥ 5 mg / dl
• Previous treatment for HBO therapy
• Secondary diabets according to ADA criteria (type 3 B-H, eg pancreopriver diabetes)
• Type 4 diabetes (gestational diabetes), pregnancy
• poor glycemic control (HbA1c\> 9.0%)
• Hyperlipidemia (low density triglycerides and lipoproteins ≥ double upper Reference limit)

Sponsors & Collaborators

• German Diabetes Center: lead

Study Sites (1)

German Diabetes Center

Düsseldorf, North Rhine-Westphalia, 40225, Germany

Location

Related Publications (1)

• Sarabhai T, Mastrototaro L, Kahl S, Bonhof GJ, Jonuscheit M, Bobrov P, Katsuyama H, Guthoff R, Wolkersdorfer M, Herder C, Meuth SG, Dreyer S, Roden M. Hyperbaric oxygen rapidly improves tissue-specific insulin sensitivity and mitochondrial capacity in humans with type 2 diabetes: a randomised placebo-controlled crossover trial. Diabetologia. 2023 Jan;66(1):57-69. doi: 10.1007/s00125-022-05797-0. Epub 2022 Sep 30.

  PMID: 36178534 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Michael Roden, Prof., MD

  German Diabetes Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 11, 2019
• First Posted: January 6, 2020
• Study Start: February 1, 2020
• Primary Completion: September 20, 2022
• Study Completion: September 20, 2022
• Last Updated: August 15, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)