search
Back to results

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

Primary Purpose

Metabolic Syndrome

Status
Unknown status
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
2 weeks of exercise in low and moderate altitude
Sponsored by
Pure Mountain Solda
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Metabolic Syndrome focused on measuring Exercise, moderate altitude, hypoxia, metabolic syndrome

Eligibility Criteria

30 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

-

Sites / Locations

  • Gutwenger Ivana

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Moderate altitude group

low altitude group

Arm Description

2 weeks of exercise at 1900 meters sea level

2 weeks of exercise at 400 meters sea level

Outcomes

Primary Outcome Measures

exercise test

Secondary Outcome Measures

BMI, BIA, metabolic and cardiorespiratory parameters

Full Information

First Posted
November 6, 2013
Last Updated
April 26, 2014
Sponsor
Pure Mountain Solda
Collaborators
Department of internal medicine, Central Hospital Bolzano, South Tyrol, Italy, Ospedale Generale Di Zona Silandro
search

1. Study Identification

Unique Protocol Identification Number
NCT02013947
Brief Title
Effects of Moderate Altitude Training on Metabolic Parameters in Voluntary Study Participants With Metabolic Syndrome
Official Title
Randomized Controlled Trial to Analyze the Effects of Moderate Altitude Training on Metabolic Parameters in Voluntary Study Participants With Metabolic Syndrome.
Study Type
Interventional

2. Study Status

Record Verification Date
April 2014
Overall Recruitment Status
Unknown status
Study Start Date
November 2013 (undefined)
Primary Completion Date
November 2013 (Actual)
Study Completion Date
December 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Pure Mountain Solda
Collaborators
Department of internal medicine, Central Hospital Bolzano, South Tyrol, Italy, Ospedale Generale Di Zona Silandro

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metabolic Syndrome
Keywords
Exercise, moderate altitude, hypoxia, metabolic syndrome

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Moderate altitude group
Arm Type
Other
Arm Description
2 weeks of exercise at 1900 meters sea level
Arm Title
low altitude group
Arm Type
Other
Arm Description
2 weeks of exercise at 400 meters sea level
Intervention Type
Other
Intervention Name(s)
2 weeks of exercise in low and moderate altitude
Intervention Description
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).
Primary Outcome Measure Information:
Title
exercise test
Time Frame
examination after 2 weeks of exercise
Secondary Outcome Measure Information:
Title
BMI, BIA, metabolic and cardiorespiratory parameters
Time Frame
examination on baseline and after the 2 weeks
Other Pre-specified Outcome Measures:
Title
blood pressure, heart rate
Time Frame
at baseline and after 2 weeks of exercise

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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 -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ivana Gutwenger
Organizational Affiliation
Pure Mountain Solda
Official's Role
Principal Investigator
Facility Information:
Facility Name
Gutwenger Ivana
City
Bressanone
State/Province
Bolzano
ZIP/Postal Code
39042
Country
Italy

12. IPD Sharing Statement

Citations:
PubMed Identifier
25885799
Citation
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.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs