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Altitude, Exercise and Glucose Metabolism in Pre-diabetic Men

Primary Purpose

Diabetes

Status
Completed
Phase
Not Applicable
Locations
Austria
Study Type
Interventional
Intervention
Walking uphill
Walking downhill
Sponsored by
Universitaet Innsbruck
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Diabetes focused on measuring glucose tolerance, hypoxia, myokines, exercise

Eligibility Criteria

50 Years - 65 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Pre-diabetes
  • male
  • age 50-65 years

Exclusion Criteria:

  • smoking
  • BMI > 30 kg/m2
  • diseases not compatible with intervention

Sites / Locations

  • Department of Sport Science, Medical Section, University of Innsbruck

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Low altitude

High altitude

Arm Description

Walking uphill Walking downhill

Walking uphill Walking downhill

Outcomes

Primary Outcome Measures

Glucose tolerance

Secondary Outcome Measures

Myokines
Cardiovascular fitness

Full Information

First Posted
June 27, 2013
Last Updated
January 17, 2019
Sponsor
Universitaet Innsbruck
Collaborators
Medical University Innsbruck
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1. Study Identification

Unique Protocol Identification Number
NCT01890876
Brief Title
Altitude, Exercise and Glucose Metabolism in Pre-diabetic Men
Official Title
Altitude-dependent Effects of Concentric and Eccentric Exercise on Glucose Metabolism in Pre-diabetic Men
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
June 2013 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universitaet Innsbruck
Collaborators
Medical University Innsbruck

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Concentric (CE) and eccentric (EE) exercises may differently affect glucose metabolism which may be additionally modified when exercises are performed in hypoxia, e.g. at moderate (1500 - 2500 m) or high (2500 - 3500 m) altitudes. However, data on the effects of glucose metabolism due to CE and EE in hypoxia are scarce but would be of utmost importance considering the increasing number of persons suffering from impaired glucose tolerance or diabetes and the unique opportunities provided by the mountainous regions of the Alps to perform CE (e.g. uphill hiking) and EE (downhill hiking, downhill skiing) at altitude between 1500 - 3500 m. Metabolic responses to exercise may be largely mediated by interleukin 6 (IL-6), which is predominantly derived from the contracting limbs and may support the maintenance of metabolic homeostasis during exercise. In addition, IL-6 is elevated with acute and chronic altitude exposure at least partly mediated via adrenergic stimulation. Thus, the type of exercise as well as hypoxia may contribute to IL-6 elevations and differences in serum IL-6 concentrations might help to explain distinctions between responses of glucose metabolism to CE and EE at low and moderate to high altitude. 32 male subjects suffering from pre-diabetes will be randomly assigned to a downhill (EE) or uphill (CE) walking group performing 9 sessions at low altitude (860 - 1360 m) and 9 sessions at moderate to high altitude (2000 - 2500 m). Between normoxic and hypoxic condition will be a break of approximately 12 month. Measurements of glucose metabolism, IL-6 plasma concentration will be performed pre, mid (day 5) and post intervention. Moreover anthropometric, strength and exercise capacity characteristics will be performed pre and post intervention. We hypothesize that EE in hypoxia is more effective in the modulation of glycemic control in pre-diabetic men than CE in hypoxia as well as EE and CE in normoxia. It is suggested that effects on glucose metabolism are associated with changes in plasma IL-6 concentrations. EE in hypoxia is expected to result in a more persistent rise of plasma IL-6 concentration than CE in hypoxia and in normoxia and to a more pronounced rise in plasma IL-6 than EE in normoxia.
Detailed Description
Not desired.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes
Keywords
glucose tolerance, hypoxia, myokines, exercise

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
32 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Low altitude
Arm Type
Active Comparator
Arm Description
Walking uphill Walking downhill
Arm Title
High altitude
Arm Type
Active Comparator
Arm Description
Walking uphill Walking downhill
Intervention Type
Other
Intervention Name(s)
Walking uphill
Intervention Description
ascending about 500 m
Intervention Type
Other
Intervention Name(s)
Walking downhill
Intervention Description
descending about 500 m
Primary Outcome Measure Information:
Title
Glucose tolerance
Time Frame
18 months
Secondary Outcome Measure Information:
Title
Myokines
Time Frame
18 months
Title
Cardiovascular fitness
Time Frame
18 months

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Pre-diabetes male age 50-65 years Exclusion Criteria: smoking BMI > 30 kg/m2 diseases not compatible with intervention
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Martin Burtscher, Professor
Organizational Affiliation
department of sport science, medical section, university innsbruck
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Sport Science, Medical Section, University of Innsbruck
City
Innsbruck
ZIP/Postal Code
6020
Country
Austria

12. IPD Sharing Statement

Citations:
PubMed Identifier
18339002
Citation
Drexel H, Saely CH, Langer P, Loruenser G, Marte T, Risch L, Hoefle G, Aczel S. Metabolic and anti-inflammatory benefits of eccentric endurance exercise - a pilot study. Eur J Clin Invest. 2008 Apr;38(4):218-26. doi: 10.1111/j.1365-2362.2008.01937.x.
Results Reference
background
PubMed Identifier
23536585
Citation
Duennwald T, Gatterer H, Groop PH, Burtscher M, Bernardi L. Effects of a single bout of interval hypoxia on cardiorespiratory control and blood glucose in patients with type 2 diabetes. Diabetes Care. 2013 Aug;36(8):2183-9. doi: 10.2337/dc12-2113. Epub 2013 Mar 27.
Results Reference
background
PubMed Identifier
19741312
Citation
Burtscher M, Gatterer H, Kunczicky H, Brandstatter E, Ulmer H. Supervised exercise in patients with impaired fasting glucose: impact on exercise capacity. Clin J Sport Med. 2009 Sep;19(5):394-8. doi: 10.1097/JSM.0b013e3181b8b6dc.
Results Reference
background
PubMed Identifier
27652031
Citation
Philippe M, Junker G, Gatterer H, Melmer A, Burtscher M. Acute effects of concentric and eccentric exercise matched for energy expenditure on glucose metabolism in healthy females: a randomized crossover trial. Springerplus. 2016 Aug 30;5(1):1455. doi: 10.1186/s40064-016-3062-z. eCollection 2016.
Results Reference
derived

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Altitude, Exercise and Glucose Metabolism in Pre-diabetic Men

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