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Altitude, Exercise and Glucose Metabolism in Pre-diabetic Men

This study is enrolling participants by invitation only.
Sponsor:
Collaborator:
Medical University Innsbruck
Information provided by (Responsible Party):
Martin Burtscher, Universitaet Innsbruck
ClinicalTrials.gov Identifier:
NCT01890876
First received: June 27, 2013
Last updated: July 4, 2013
Last verified: July 2013
  Purpose

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.


Condition Intervention
Diabetes
Other: Walking uphill
Other: Walking downhill

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Altitude-dependent Effects of Concentric and Eccentric Exercise on Glucose Metabolism in Pre-diabetic Men

Resource links provided by NLM:


Further study details as provided by Universitaet Innsbruck:

Primary Outcome Measures:
  • Glucose tolerance [ Time Frame: 18 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Myokines [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  • Cardiovascular fitness [ Time Frame: 18 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 32
Study Start Date: June 2013
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Low altitude
Walking uphill Walking downhill
Other: Walking uphill
ascending about 500 m
Other: Walking downhill
descending about 500 m
Active Comparator: High altitude
Walking uphill Walking downhill
Other: Walking uphill
ascending about 500 m
Other: Walking downhill
descending about 500 m

Detailed Description:

Not desired.

  Eligibility

Ages Eligible for Study:   50 Years to 65 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • smoking
  • BMI > 30 kg/m2
  • diseases not compatible with intervention
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01890876

Locations
Austria
Department of Sport Science, Medical Section, University of Innsbruck
Innsbruck, Austria, 6020
Sponsors and Collaborators
Universitaet Innsbruck
Medical University Innsbruck
Investigators
Principal Investigator: Martin Burtscher, Professor department of sport science, medical section, university innsbruck
  More Information

Publications:
Responsible Party: Martin Burtscher, Univ.-Prof. Mag. DDr. Martin Burtscher, Universitaet Innsbruck
ClinicalTrials.gov Identifier: NCT01890876     History of Changes
Other Study ID Numbers: AN5029
Study First Received: June 27, 2013
Last Updated: July 4, 2013
Health Authority: Austria: Ethikkommission

Keywords provided by Universitaet Innsbruck:
glucose tolerance, hypoxia, myokines, exercise

Additional relevant MeSH terms:
Prediabetic State
Diabetes Mellitus
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on November 20, 2014