NCT04450745

Physical Exercise in Normobaric Hypoxia and Normoxia in Type 1 Diabetic Patients

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Silesian Centre for Heart Diseases · Academic / Other
• Sex: Male
• Age: 30 Years – 45 Years
• Healthy volunteers: Not accepted

Summary

Physical activity, along with proper nutrition, is the basis for the behavioral treatment of diabetes. In recent years exercise training in normobaric hypoxia is used in training programs for athletes and in rehabilitation. The aim of this study is the assessment of physical exercise in normobaric hypoxia condition on metabolic control of diabetes: blood glucose profile, its stability, HbA1c value, hypoglycemia: frequency, level, severity and time of occurrence, insulin demand, maximal muscle strength level, VO2max and anthropometric parameters.

Detailed description

Hypoxia leads to HIF-1 production (hypoxia inducible factor 1) which regulates expression of many genes (eg. gene responsible for erythropoetin production). It also stimulates angiogenesis, muscle hypertrophy and glycolytic energy production by transactivating genes involved in extracellular glucose import. Before starting the training program all participants will be assessed by cardiologist. Then the incremental exercise test will be performed to determine aerobic capacity (VO2max). Recruited patients ( type 1 male diabetic patients) will be divided into 2 arms: exercise in normoxia or in normobaric hypoxia. Hypoxic chamber is set to contain equivalent to an altitude of 2500 meters above see level (indoor air composition: 15,4% of O2 and 84,7% of N). Training program will be the same for all participants: 60 minutes sessions twice a week for 6 weeks of mixed exercise: aerobic and anaerobic. Glycemia will be monitored by Flash Glucose Monitoring (Free Style Libre) and the same glucometer model by all patients. At baseline and after 6 weeks: echocardiography, ECG and incremental exercise test, ECG and blood pressure monitoring, lipid profile and diabetes control parameters will be performed in all patients.

Conditions

• type1diabetes

Interventions

Type	Name	Description
BEHAVIORAL	Exercise in hypoxia	60 minutes training program of mixed exercise in normobaric hypoxic chamber
BEHAVIORAL	Exercise in normoxia	60 minutes training program of mixed exercise in regular air conditions

Timeline

• Start date: 2019-10-30
• Primary completion: 2020-08-31
• Completion: 2020-09-30
• First posted: 2020-06-30
• Last updated: 2022-04-28

Locations

1 site across 1 country: Poland