Randomized Controlled Trial to Analyze the Effects of Moderate Altitude Training on Metabolic Parameters in Voluntary Study Participants With Metabolic Syndrome.
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Metabolic Syndrome
- Sponsor
- Pure Mountain Solda
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- exercise test
- Last Updated
- 12 years ago
Overview
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.
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.
Investigators
Dr. Gutwenger Ivana
Dr. med. Gutwenger Ivana
Pure Mountain Solda
Eligibility Criteria
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
Outcomes
Primary Outcomes
exercise test
Time Frame: examination after 2 weeks of exercise
Secondary Outcomes
- BMI, BIA, metabolic and cardiorespiratory parameters(examination on baseline and after the 2 weeks)