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

Primary Purpose

Obesity, Non-insulin-dependent Diabetes Mellitus

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
HBO therapy
Hyperbaric room air
Sponsored by
German Diabetes Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Obesity focused on measuring Oxidative stress, Insulin resistance

Eligibility Criteria

30 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • German Diabetes Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Hyperbaric oxygen therapy

Hyperbaric room air

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
November 13, 2011
Last Updated
June 11, 2023
Sponsor
German Diabetes Center
Collaborators
Heinrich-Heine University, Duesseldorf
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1. Study Identification

Unique Protocol Identification Number
NCT01472328
Brief Title
Effects of HBO Therapy on Muscular Insulin Resistence in Type 2 Diabetes
Official Title
Effects of HBO Therapy on Muscular Insulin Resistence in Type 2 Diabetes
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
March 2012 (Actual)
Primary Completion Date
March 2015 (Actual)
Study Completion Date
August 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
German Diabetes Center
Collaborators
Heinrich-Heine University, Duesseldorf

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Non-insulin-dependent Diabetes Mellitus
Keywords
Oxidative stress, Insulin resistance

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Hyperbaric oxygen therapy
Arm Type
Experimental
Arm Description
Effect of 2 hrs HBO therapy on muscular insulin sensitivity and resistance in obesity and type 2 diabetes mellitus
Arm Title
Hyperbaric room air
Arm Type
Sham Comparator
Arm Description
Effect of 2 hrs hyperbaric room air herapy on muscular insulin sensitivity and resistance in obesity and type 2 diabetes mellitus
Intervention Type
Procedure
Intervention Name(s)
HBO therapy
Other Intervention Name(s)
oxidative stress, antioxidative capacity
Intervention Description
Effect of 2 hrs HBO therapy on muscular insulin sensitivity and resistance in obesity and type 2 diabetes mellitus
Intervention Type
Procedure
Intervention Name(s)
Hyperbaric room air
Other Intervention Name(s)
HBO therapy, oxidative stress
Intervention Description
Effect of 2 hrs hyperbaric room air on muscular insulin sensitivity and resistance in obesity and type 2 diabetes mellitus
Primary Outcome Measure Information:
Title
Skeletal muscle insulin sensitivity
Description
Determination of the influence of 2 hours hyperoxygenation on insulin sensitivity redox balance and lipid metabolites of skeletal muscle in patients with T2DM
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Roden, Prof., MD
Organizational Affiliation
German Diabetes Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
German Diabetes Center
City
Düsseldorf
ZIP/Postal Code
40225
Country
Germany

12. IPD Sharing Statement

Links:
URL
https://ddz.de/
Description
Homepage

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

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