Effects of HBO Therapy on Muscular Insulin Resistence in Type 2 Diabetes

NCT ID: NCT01472328

Last Updated: 2023-06-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-03-31

Study Completion Date

2015-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Hyperbaric oxygen therapy (HBO) is applied for several diseases. The effect on insulin sensitivity is yet unknown. Hypothesis: HBO therapy improves insulin sensitivity in patients.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

HBO therapy is applied to improve wound healing in diabetic patients with foot ulcera. However, it might induce oxidative stress as well as improve antioxidative capacity. The effects on insulin sensitivity in humans and will be tested in the study.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Obesity Non-insulin-dependent Diabetes Mellitus

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Hyperbaric oxygen therapy

Effect of 2 hrs HBO therapy on muscular insulin sensitivity and resistance in obesity and type 2 diabetes mellitus

Group Type EXPERIMENTAL

HBO therapy

Intervention Type PROCEDURE

Effect of 2 hrs HBO therapy on muscular insulin sensitivity and resistance in obesity and type 2 diabetes mellitus

Hyperbaric room air

Effect of 2 hrs hyperbaric room air herapy on muscular insulin sensitivity and resistance in obesity and type 2 diabetes mellitus

Group Type SHAM_COMPARATOR

Hyperbaric room air

Intervention Type PROCEDURE

Effect of 2 hrs hyperbaric room air on muscular insulin sensitivity and resistance in obesity and type 2 diabetes mellitus

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

HBO therapy

Effect of 2 hrs HBO therapy on muscular insulin sensitivity and resistance in obesity and type 2 diabetes mellitus

Intervention Type PROCEDURE

Hyperbaric room air

Effect of 2 hrs hyperbaric room air on muscular insulin sensitivity and resistance in obesity and type 2 diabetes mellitus

Intervention Type PROCEDURE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

oxidative stress antioxidative capacity HBO therapy oxidative stress

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Aged ≥ 30 years- ≤ 70 years
* Balanced sex (50: 50)
* BMI 20- 25 kg/m 2 normal- weight group
* BMI 35- 39,9 kg/m 2 (Obese typ II)

Exclusion Criteria

* Acute illness 2 weeks before start of examination
* Autoimmune or Immune disorder deseases (Leukozyten \< 5000/µl
* Renal insufficiency (Kreatin \> 1,5 mg/dl)
* Heart disease, condition after heart attack
* Anemia (Hb \<12g/l, contolled before every day of eximination) or blood donations 4weeks before eximinatin.
* Participation in another trial within the last 2 weeks
* Pharmacological- immuno therapy (Cortisol, Antihistaminika, ASS)
* Thyroid disorders
* Glitazone or Insulin- Therapy
* Pragnancy, Lactation, Menstruation
* Smoking cigaretts, Alcohol- and drug abuse
* Psychiatric disorders
* Risk for/ or diagnosed HIV/ AIDS or Hepatitis B/C
* Liver disease, which are not caused by non- alcoholic steato- hepatitis
* Working on night shifts or irregular rhythem of night- day
* Impaired wound healing or clotting disorders
* Allergic reaction to local anesthetics
* Malignant cancer
Minimum Eligible Age

30 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Heinrich-Heine University, Duesseldorf

OTHER

Sponsor Role collaborator

German Diabetes Center

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Michael Roden, Prof., MD

Role: PRINCIPAL_INVESTIGATOR

German Diabetes Center

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

German Diabetes Center

Düsseldorf, , Germany

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Germany

Related Links

Access external resources that provide additional context or updates about the study.

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

ROS Paradoxon

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Phase 1 Study of HBN-1
NCT04094857 UNKNOWN PHASE1
Heat Therapy in Type 2 Diabetes
NCT06596967 RECRUITING PHASE1