Metabolic SyndromeNCT02013947
Effects of Moderate Altitude Training on Metabolic Parameters in Voluntary Study Participants With Metabolic Syndrome
A study testing 2 weeks of exercise in low and moderate altitude in people with Metabolic Syndrome, run by Pure Mountain Solda at 1 site in Italy.
Trial summary
The metabolic syndrome is a cluster of metabolic disorders (obesity, hyperglycemia, dyslipidemia and hypertension) and it is a risk factor for the development of type 2 diabetes and atherosclerotic cardiovascular disease. There are several definitions for the metabolic syndrome. Read more about this study
- Who is it for?
- Ages 30 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Metabolic Syndrome
- What is being tested?
- 2 weeks of exercise in low and moderate altitude
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteItaly
- Study dates
- Nov 2013to Dec 2014
- 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 30 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- waist circumference in men >102 cm, in women >88cm serum triglycerides >150 mg/dl or drug treatment serum HDL cholesterol < 40 mg/dl in men or <50 mg/dl in women or drug treatment blood pressure >130/95 or drug treatment fasting plasma glucose >100 mg/dl or drug treatment 3 from this 5 criteria -
Who cannot join
- positive anamnesis for myocardial infarction,chronic heart disease, cerebral ischemic occurrences , mental and psychic disorders, not controlled hypertension or hyperglycemia, tumor desease, lung disorders,pregnancy
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Controlled Trial to Analyze the Effects of Moderate Altitude Training on Metabolic Parameters in Voluntary Study Participants With Metabolic Syndrome.
The metabolic syndrome is a cluster of metabolic disorders (obesity, hyperglycemia, dyslipidemia and hypertension) and it is a risk factor for the development of type 2 diabetes and atherosclerotic cardiovascular disease. There are several definitions for the metabolic syndrome. The AHA/NHLBI (American Heart association/National Heart Lung Blood Institution)and IDF (International Diabetes Federation)2009 criteria are frequently used to comparing data from studies. Prevention or reduction of obesity and lifestyle modification with physical activity is the main therapeutic goal in patients with metabolic syndrome. Recent studies have shown that exercise in moderate altitude or in moderate hypoxia improved glycemic parameters. The influence of training in moderate altitude on circulating metabolites and hormones in terms of substrate utilization is unclear. The adiponectin seems to play an important role in the homeostasis of adipose tissue and in the pathogenesis of the metabolic syndrome and physical activity seems to have a positive effect on adiponectin concentrations. In this study with randomized controlled pretest-posttest-design we want to investigate the effects of physical activity in moderate hypoxia on biomarkers of metabolic syndrome.
Read the detailed description
Participate can subjects aged 40-70 years with metabolic syndrome according to the definition of AHA/NHLBI and IDF 2009 after declaring orally and written consent and if they authorize to process personal and sanitary data. The study involve 80 subjects with metabolic syndrome. They will be recruited by general practitioner, elect from the principal investigator and invited to participate in the trial. The 80 participants will be randomized in two groups.
Group A, moderate altitude group, 1900 m, 40 participants Group B, low altitude group, 400m, 40 participants Group A will spend 2 weeks at an altitude of 1900m and participants absolve a training program (3h, 4x a week, total training time 24h, training intensity 55-65% of maximal heart rate).
Group B will spend spend 2 weeks at an altitude of 400m and participants absolve a training program (3h, 4x a week, total training time 24h, training intensity 55-65% of maximal heart rate).
Nutrition does not follow any specific diet plan, both groups receive an equivalent balanced feeding.
Clinical examinations at the beginning and at the end of the study laboratory tests well be documented and compared(fasting plasma glucose, triglycerides, HDL-C, LDL-C, insulin, C-peptid, free fatty acids, adiponectin, leptin, HbA1c, Metabolon cluster, c reactive protein, vit D3). Also BMI, BIA bioimpedance analysis, blood pressure, heart rate, egg, Physical status, exercise test.
- Conditions
- Metabolic Syndrome
- Being tested
- 2 weeks of exercise in low and moderate altitude
- Keywords
- Exercise, moderate altitude, hypoxia, metabolic syndrome
- Medical subject headings
- Metabolic Syndrome, Motor Activity, Hypoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
2 weeks of exercise in low and moderate altitudeOther
Group A will spend 2 weeks at an altitude of 1900m and participants absolve a training program (3h, 4x a week, total training time 24h, training intensity 55-65% of maximal heart rate).
Group B will spend spend 2 weeks at an altitude of 400m and participants absolve a training program (3h, 4x a week, total training time 24h, training intensity 55-65% of maximal heart rate).
| Study group | Role | What they receive |
|---|---|---|
| Moderate altitude group | Other | 2 weeks of exercise at 1900 meters sea level Receives: Other: 2 weeks of exercise in low and moderate altitude |
| low altitude group | Other | 2 weeks of exercise at 400 meters sea level Receives: Other: 2 weeks of exercise in low and moderate altitude |
What is being measured
The primary outcome is the main question the study is designed to answer.
exercise test
Measured: examination after 2 weeks of exercise
Secondary outcomes (1)
BMI, BIA, metabolic and cardiorespiratory parameters
Measured: examination on baseline and after the 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2013 (estimated)
- Study startNov 2013
- Primary completionNov 2013
- Study completionDec 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Metabolic SyndromeStudies 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
- Single group
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pure Mountain Solda
- Sponsor type
- University, hospital or other
- Collaborators
- Department of internal medicine, Central Hospital Bolzano, South Tyrol, Italy, Ospedale Generale Di Zona Silandro
- Responsible party
- Principal investigator, Dr. Gutwenger Ivana, Pure Mountain Solda
- Investigators
- Ivana Gutwenger, Principal investigator, Pure Mountain Solda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02013947
- Sponsor's protocol ID
- ESF 2/308/2010
- Status last verified
- Apr 2014
- First submitted
- 6 Nov 2013
- Last updated
- 29 Apr 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Gutwenger I, Hofer G, Gutwenger AK, Sandri M, Wiedermann CJ. Pilot study on the effects of a 2-week hiking vacation at moderate versus low altitude on plasma parameters of carbohydrate and lipid metabolism in patients with metabolic syndrome. BMC Res Notes. 2015 Mar 28;8:103. doi: 10.1186/s13104-015-1066-3.
PubMed 25885799
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial to Analyze the Effects of Moderate Altitude Training on Metabolic Parameters in Voluntary Study Participants With Metabolic Syndrome.
- ClinicalTrials.gov ID
- NCT02013947
- Acronym / sponsor ID
- ESF 2/308/2010
- Conditions
- Metabolic Syndrome
- Keywords
- Exercise, moderate altitude, hypoxia, metabolic syndrome
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Pure Mountain SoldaUniversity, hospital or other
- Collaborators
- Department of internal medicine, Central Hospital Bolzano, South Tyrol, Italy, Ospedale Generale Di Zona Silandro
- Study start
- Nov 2013
- Primary completion
- Nov 2013 (actual)
- Study completion
- Dec 2014 (estimated)
- First posted
- 17 Dec 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.
The metabolic syndrome is a cluster of metabolic disorders (obesity, hyperglycemia, dyslipidemia and hypertension) and it is a risk factor for the development of type 2 diabetes and atherosclerotic cardiovascular disease. There are several definitions for the metabolic syndrome. The AHA/NHLBI (American Heart association/National Heart Lung Blood Institution)and IDF (International Diabetes Federation)2009 criteria are frequently used to comparing data from studies. Prevention or reduction of obesity and lifestyle modification with physical activity is the main therapeutic goal in patients with metabolic syndrome. Recent studies have shown that exercise in moderate altitude or in moderate hypoxia improved glycemic parameters. The influence of training in moderate altitude on circulating metabolites and hormones in terms of substrate utilization is unclear. The adiponectin seems to play an important role in the homeostasis of adipose tissue and in the pathogenesis of the metabolic syndrome and physical activity seems to have a positive effect on adiponectin concentrations. In this study with randomized controlled pretest-posttest-design we want to investigate the effects of physical activity in moderate hypoxia on biomarkers of metabolic syndrome.
Detailed description
Participate can subjects aged 40-70 years with metabolic syndrome according to the definition of AHA/NHLBI and IDF 2009 after declaring orally and written consent and if they authorize to process personal and sanitary data. The study involve 80 subjects with metabolic syndrome. They will be recruited by general practitioner, elect from the principal investigator and invited to participate in the trial. The 80 participants will be randomized in two groups.
Group A, moderate altitude group, 1900 m, 40 participants Group B, low altitude group, 400m, 40 participants Group A will spend 2 weeks at an altitude of 1900m and participants absolve a training program (3h, 4x a week, total training time 24h, training intensity 55-65% of maximal heart rate).
Group B will spend spend 2 weeks at an altitude of 400m and participants absolve a training program (3h, 4x a week, total training time 24h, training intensity 55-65% of maximal heart rate).
Nutrition does not follow any specific diet plan, both groups receive an equivalent balanced feeding.
Clinical examinations at the beginning and at the end of the study laboratory tests well be documented and compared(fasting plasma glucose, triglycerides, HDL-C, LDL-C, insulin, C-peptid, free fatty acids, adiponectin, leptin, HbA1c, Metabolon cluster, c reactive protein, vit D3). Also BMI, BIA bioimpedance analysis, blood pressure, heart rate, egg, Physical status, exercise test.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Moderate altitude group | Other | Other: 2 weeks of exercise in low and moderate altitude2 weeks of exercise at 1900 meters sea level |
| low altitude group | Other | Other: 2 weeks of exercise in low and moderate altitude2 weeks of exercise at 400 meters sea level |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- waist circumference in men >102 cm, in women >88cm serum triglycerides >150 mg/dl or drug treatment serum HDL cholesterol < 40 mg/dl in men or <50 mg/dl in women or drug treatment blood pressure >130/95 or drug treatment fasting plasma glucose >100 mg/dl or drug treatment 3 from this 5 criteria -
Key exclusion criteria (2 listed)
- positive anamnesis for myocardial infarction,chronic heart disease, cerebral ischemic occurrences , mental and psychic disorders, not controlled hypertension or hyperglycemia, tumor desease, lung disorders,pregnancy
- -
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 |
|---|---|---|
| 2 weeks of exercise in low and moderate altitudeGroup A will spend 2 weeks at an altitude of 1900m and participants absolve a training program (3h, 4x a week, total training time 24h, training intensity 55-65% of maximal heart rate). Group B will spend spend 2 weeks at an altitude of 400m and participants absolve a training program (3h, 4x a week, total training time 24h, training intensity 55-65% of maximal heart rate). | Other | Moderate altitude group, low altitude group |
Primary outcome
exercise test
Time frame: examination after 2 weeks of exercise
1 secondary outcome
BMI, BIA, metabolic and cardiorespiratory parameters
Time frame: examination on baseline and after the 2 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2014.
- Derived from this study: PubMed 25885799Gutwenger I, Hofer G, Gutwenger AK, Sandri M, Wiedermann CJ. Pilot study on the effects of a 2-week hiking vacation at moderate versus low altitude on plasma parameters of carbohydrate and lipid metabolism in patients with metabolic syndrome. BMC Res Notes. 2015 Mar 28;8:103. doi: 10.1186/s13104-015-1066-3.
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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.
Ivana Gutwenger principal investigator
Pure Mountain Solda
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 2 weeks of exercise in low and moderate altitude in people with Metabolic Syndrome, run by Pure Mountain Solda at 1 site in Italy.
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 1 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 29 Apr 2014. 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 Italy. 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?
Results are not available in the source record.
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?
exercise test (time frame: examination after 2 weeks of exercise). 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 NCT02013947, which also lists 1 linked publication.
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 29 Apr 2014.