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

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.

Study Overview

• Status: Unknown
• Conditions: Metabolic Syndrome
• Intervention / Treatment: Other: 2 weeks of exercise in low and moderate altitude

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 Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Bolzano
    • Bressanone, Bolzano, Italy, 39042
      • Gutwenger Ivana

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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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Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: SINGLE_GROUP
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: Moderate altitude group; 2 weeks of exercise at 1900 meters sea level	Other: 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).
OTHER: low altitude group; 2 weeks of exercise at 400 meters sea level	Other: 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
exercise test	examination after 2 weeks of exercise

Secondary Outcome Measures

Outcome Measure	Time Frame
BMI, BIA, metabolic and cardiorespiratory parameters	examination on baseline and after the 2 weeks

Other Outcome Measures

Outcome Measure	Time Frame
blood pressure, heart rate	at baseline and after 2 weeks of exercise

Collaborators and Investigators

• Sponsor: Pure Mountain Solda
• Collaborators: Department of internal medicine, Central Hospital Bolzano, South Tyrol, Italy; Ospedale Generale Di Zona Silandro
• Investigators: Principal Investigator: Ivana Gutwenger, Pure Mountain Solda

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start: November 1, 2013
• Primary Completion (ACTUAL): November 1, 2013
• Study Completion (ANTICIPATED): December 1, 2014

Study Registration Dates

• First Submitted: November 6, 2013
• First Submitted That Met QC Criteria: December 11, 2013
• First Posted (ESTIMATE): December 17, 2013

Study Record Updates

• Last Update Posted (ESTIMATE): April 29, 2014
• Last Update Submitted That Met QC Criteria: April 26, 2014
• Last Verified: April 1, 2014

More Information

Terms related to this study

• Keywords: Exercise, moderate altitude, hypoxia, metabolic syndrome
• Additional Relevant MeSH Terms: Pathologic Processes; Glucose Metabolism Disorders; Metabolic Diseases; Disease; Insulin Resistance; Hyperinsulinism; Syndrome; Metabolic Syndrome
• Other Study ID Numbers: ESF 2/308/2010