NCT01890876

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
32

participants targeted

Target at below P25 for not_applicable diabetes

Timeline
Completed

Started Jun 2013

Typical duration for not_applicable diabetes

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

Study Start

First participant enrolled

June 1, 2013

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

June 27, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 2, 2013

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

January 22, 2019

Status Verified

January 1, 2019

Enrollment Period

1.5 years

First QC Date

June 27, 2013

Last Update Submit

January 17, 2019

Conditions

Keywords

glucose tolerance, hypoxia, myokines, exercise

Outcome Measures

Primary Outcomes (1)

  • Glucose tolerance

    18 months

Secondary Outcomes (2)

  • Myokines

    18 months

  • Cardiovascular fitness

    18 months

Study Arms (2)

Low altitude

ACTIVE COMPARATOR

Walking uphill Walking downhill

Other: Walking uphillOther: Walking downhill

High altitude

ACTIVE COMPARATOR

Walking uphill Walking downhill

Other: Walking uphillOther: Walking downhill

Interventions

ascending about 500 m

High altitudeLow altitude

descending about 500 m

High altitudeLow altitude

Eligibility Criteria

Age50 Years - 65 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Sport Science, Medical Section, University of Innsbruck

Innsbruck, 6020, Austria

Location

Related Publications (4)

  • 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.

    PMID: 18339002BACKGROUND
  • 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.

    PMID: 23536585BACKGROUND
  • 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.

    PMID: 19741312BACKGROUND
  • 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.

MeSH Terms

Conditions

Diabetes MellitusHypoxiaMotor Activity

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and SymptomsBehavior

Study Officials

  • Martin Burtscher, Professor

    department of sport science, medical section, university innsbruck

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Univ.-Prof. Mag. DDr. Martin Burtscher

Study Record Dates

First Submitted

June 27, 2013

First Posted

July 2, 2013

Study Start

June 1, 2013

Primary Completion

December 1, 2014

Study Completion

December 1, 2015

Last Updated

January 22, 2019

Record last verified: 2019-01

Locations