NCT01472328

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable obesity

Timeline
Completed

Started Mar 2012

Typical duration for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 13, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 16, 2011

Completed
4 months until next milestone

Study Start

First participant enrolled

March 1, 2012

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2015

Completed
Last Updated

June 13, 2023

Status Verified

June 1, 2023

Enrollment Period

3 years

First QC Date

November 13, 2011

Last Update Submit

June 11, 2023

Conditions

ObesityNon-insulin-dependent Diabetes Mellitus

Keywords

Oxidative stressInsulin resistance

Outcome Measures

Primary Outcomes (1)

  • Skeletal muscle insulin sensitivity

    Determination of the influence of 2 hours hyperoxygenation on insulin sensitivity redox balance and lipid metabolites of skeletal muscle in patients with T2DM

    2 years

Study Arms (2)

Hyperbaric oxygen therapy

EXPERIMENTAL

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

Procedure: HBO therapy

Hyperbaric room air

SHAM COMPARATOR

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

Procedure: Hyperbaric room air

Interventions

HBO therapyPROCEDURE

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

Also known as: oxidative stress, antioxidative capacity
Hyperbaric oxygen therapy
Hyperbaric room airPROCEDURE

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

Also known as: HBO therapy, oxidative stress
Hyperbaric room air

Eligibility Criteria

Age30 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

German Diabetes Center

Düsseldorf, 40225, Germany

Location

Related Links

MeSH Terms

Conditions

ObesityDiabetes Mellitus, Type 2Insulin Resistance

Interventions

Oxidative Stress

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsDiabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesEndocrine System DiseasesHyperinsulinism

Intervention Hierarchy (Ancestors)

MetabolismStress, PhysiologicalPhysiological Phenomena

Study Officials

  • Michael Roden, Prof., MD

    German Diabetes Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 13, 2011

First Posted

November 16, 2011

Study Start

March 1, 2012

Primary Completion

March 1, 2015

Study Completion

August 1, 2015

Last Updated

June 13, 2023

Record last verified: 2023-06

Locations

DE(1)