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

This study is enrolling participants by invitation only.
Sponsor:
Collaborators:
Department of internal medicine, Central Hospital Bolzano, South Tyrol, Italy
Ospedale Generale Di Zona Silandro
Information provided by (Responsible Party):
Dr. Gutwenger Ivana, Pure Mountain Solda
ClinicalTrials.gov Identifier:
NCT02013947
First received: November 6, 2013
Last updated: April 26, 2014
Last verified: April 2014

November 6, 2013
April 26, 2014
November 2013
November 2013   (final data collection date for primary outcome measure)
exercise test [ Time Frame: examination after 2 weeks of exercise ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT02013947 on ClinicalTrials.gov Archive Site
BMI, BIA, metabolic and cardiorespiratory parameters [ Time Frame: examination on baseline and after the 2 weeks ] [ Designated as safety issue: Yes ]
Same as current
  • blood pressure, heart rate [ Time Frame: at baseline and after 2 weeks of exercise ] [ Designated as safety issue: Yes ]
  • blood pressure, heart rate [ Time Frame: at baseline and after 2 weeks of exercise ] [ Designated as safety issue: No ]
Same as current
 
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.

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.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Prevention
Metabolic Syndrome
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).

  • Moderate altitude group
    2 weeks of exercise at 1900 meters sea level
    Intervention: Other: 2 weeks of exercise in low and moderate altitude
  • low altitude group
    2 weeks of exercise at 400 meters sea level
    Intervention: Other: 2 weeks of exercise in low and moderate altitude
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Enrolling by invitation
40
December 2014
November 2013   (final data collection date for primary outcome measure)

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

-

Both
30 Years to 70 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Italy
 
NCT02013947
ESF 2/308/2010
Yes
Dr. Gutwenger Ivana, Pure Mountain Solda
Pure Mountain Solda
  • Department of internal medicine, Central Hospital Bolzano, South Tyrol, Italy
  • Ospedale Generale Di Zona Silandro
Principal Investigator: Ivana Gutwenger Pure Mountain Solda
Pure Mountain Solda
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP