Effects of Moderate Altitude Training on Metabolic Parameters in Voluntary Study Participants With Metabolic Syndrome

NCT ID: NCT02013947

Last Updated: 2014-04-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-11-30

Study Completion Date

2014-12-31

Brief Summary

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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

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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

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Metabolic Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Investigators

Study Groups

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Moderate altitude group

2 weeks of exercise at 1900 meters sea level

Group Type OTHER

2 weeks of exercise in low and moderate altitude

Intervention Type OTHER

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).

low altitude group

2 weeks of exercise at 400 meters sea level

Group Type OTHER

2 weeks of exercise in low and moderate altitude

Intervention Type OTHER

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).

Interventions

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2 weeks of exercise in low and moderate altitude

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).

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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 -

Exclusion Criteria

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

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Minimum Eligible Age

30 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Department of internal medicine, Central Hospital Bolzano, South Tyrol, Italy

UNKNOWN

Sponsor Role collaborator

Ospedale Generale Di Zona Silandro

OTHER

Sponsor Role collaborator

Pure Mountain Solda

OTHER

Sponsor Role lead

Responsible Party

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Dr. Gutwenger Ivana

Dr. med. Gutwenger Ivana

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ivana Gutwenger

Role: PRINCIPAL_INVESTIGATOR

Pure Mountain Solda

Locations

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Gutwenger Ivana

Brixen, Bolzano, Italy

Site Status

Countries

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Italy

References

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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.

Reference Type DERIVED
PMID: 25885799 (View on PubMed)

Other Identifiers

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ESF 2/308/2010

Identifier Type: -

Identifier Source: org_study_id

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