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

NCT02013947 | Unknown DMC

• 1 other identifier: ESF 2/308/2010
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Metabolic Syndrome

Keywords

Exercise, moderate altitude, hypoxia, metabolic syndrome

Outcome Measures

Primary Outcomes (1)

• exercise test

  examination after 2 weeks of exercise

Secondary Outcomes (1)

• BMI, BIA, metabolic and cardiorespiratory parameters

  examination on baseline and after the 2 weeks

Other Outcomes (1)

• blood pressure, heart rate

  at baseline and after 2 weeks of exercise

Study Arms (2)

Moderate altitude group

OTHER

2 weeks of exercise at 1900 meters sea level

Other: 2 weeks of exercise in low and moderate altitude

low altitude group

OTHER

2 weeks of exercise at 400 meters sea level

Other: 2 weeks of exercise in low and moderate altitude

Interventions

2 weeks of exercise in low and moderate altitude 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).

Moderate altitude group; low altitude group

Eligibility Criteria

• Age: 30 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 -

You may not qualify if:

• 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

Sponsors & Collaborators

• Pure Mountain Solda: lead
• Department of internal medicine, Central Hospital Bolzano, South Tyrol, Italy: collaborator
• Ospedale Generale Di Zona Silandro: collaborator

Study Sites (1)

Gutwenger Ivana

Brixen, Bolzano, 39042, Italy

Location

Related Publications (1)

• 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.

  PMID: 25885799 DERIVED

MeSH Terms

Conditions

Metabolic Syndrome; Motor Activity; Hypoxia

Interventions

Exercise

Condition Hierarchy (Ancestors)

Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Behavior; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Ivana Gutwenger

  Pure Mountain Solda

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. med. Gutwenger Ivana

Study Record Dates

• First Submitted: November 6, 2013
• First Posted: December 17, 2013
• Study Start: November 1, 2013
• Primary Completion: November 1, 2013
• Study Completion: December 1, 2014
• Last Updated: April 29, 2014

Record last verified: 2014-04

Locations

IT (1)