DiabetesNCT01890876
Altitude, Exercise and Glucose Metabolism in Pre-diabetic Men
A study testing Walking uphill and Walking downhill in people with Diabetes, run by Universitaet Innsbruck at 1 site in Austria.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 65 years, men only
- Conditions the study is for
- Diabetes
- What is being tested?
- Walking uphill and Walking downhill
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteAustria
- Study dates
- Jun 2013to Dec 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 65 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Pre-diabetes
- male
- age 50-65 years
Who cannot join
- smoking
- BMI > 30 kg/m2
- diseases not compatible with intervention
Trial locations and contacts
1 site in 1 country.
Austria1 site
Department of Sport Science, Medical Section, University of Innsbruck
Innsbruck, 6020
About this study
Official title: Altitude-dependent Effects of Concentric and Eccentric Exercise on Glucose Metabolism in Pre-diabetic Men
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.
Read the detailed description
Not desired.
- Conditions
- Diabetes
- Being tested
- Walking uphill, Walking downhill
- Keywords
- glucose tolerance, hypoxia, myokines, exercise
- Medical subject headings
- Diabetes Mellitus, Hypoxia, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Walking uphillOther
ascending about 500 m
Walking downhillOther
descending about 500 m
| Study group | Role | What they receive |
|---|---|---|
| Low altitude | Active comparator | Walking uphill Walking downhill Receives: Other: Walking uphill; Other: Walking downhill |
| High altitude | Active comparator | Walking uphill Walking downhill Receives: Other: Walking uphill; Other: Walking downhill |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glucose tolerance
Measured: 18 months
Secondary outcomes (2)
Myokines
Measured: 18 months
Cardiovascular fitness
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2013 (estimated)
- Study startJun 2013
- Primary completionDec 2014
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitaet Innsbruck
- Sponsor type
- University, hospital or other
- Collaborators
- Medical University Innsbruck
- Responsible party
- Principal investigator, Martin Burtscher, Universitaet Innsbruck
- Investigators
- Martin Burtscher, Professor, Principal investigator, department of sport science, medical section, university innsbruck
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01890876
- Sponsor's protocol ID
- AN5029
- Status last verified
- Jan 2019
- First submitted
- 27 Jun 2013
- Last updated
- 22 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 18339002Duennwald 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.
PubMed 23536585Burtscher 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.
PubMed 19741312Philippe 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.
PubMed 27652031
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Altitude-dependent Effects of Concentric and Eccentric Exercise on Glucose Metabolism in Pre-diabetic Men
- ClinicalTrials.gov ID
- NCT01890876
- Acronym / sponsor ID
- AN5029
- Conditions
- Diabetes
- Keywords
- glucose tolerance, hypoxia, myokines, exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Universitaet InnsbruckUniversity, hospital or other
- Collaborators
- Medical University Innsbruck
- Study start
- Jun 2013
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 2 Jul 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low altitude | Active comparator | Other: Walking uphill, Other: Walking downhillWalking uphill Walking downhill |
| High altitude | Active comparator | Other: Walking uphill, Other: Walking downhillWalking uphill Walking downhill |
Who may qualify
- Ages
- 50 to 65 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Pre-diabetes
- male
- age 50-65 years
Key exclusion criteria (3 listed)
- smoking
- BMI > 30 kg/m2
- diseases not compatible with intervention
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Walking uphillascending about 500 m | Other | High altitude, Low altitude |
| Walking downhilldescending about 500 m | Other | High altitude, Low altitude |
Primary outcome
Glucose tolerance
Time frame: 18 months
2 secondary outcomes
Myokines
Time frame: 18 months
Cardiovascular fitness
Time frame: 18 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2019.
- Background: PubMed 18339002Drexel 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.
- Background: PubMed 23536585Duennwald 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.
- Background: PubMed 19741312Burtscher 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.
- Derived from this study: PubMed 27652031Philippe 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Martin Burtscher, Professor principal investigator
department of sport science, medical section, university innsbruck
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Walking uphill and Walking downhill in people with Diabetes, run by Universitaet Innsbruck at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glucose tolerance (time frame: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01890876, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2019.