Skip to main content
OpenTrials
Completed

NCT Number: NCT04450745

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Type1diabetes

Age range

30 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Department of Internal Diseases, Diabetology and Cardiometabolic Disorders, School of Medicine with the Division of Dentistry in Zabrze, Medical University of Silesia in Katowice, Poland

Zabrze, Silesian Voivodeship, 41-800, Poland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • type 1 diabetes of at least 10 years duration
  • low physical activity
  • BMI 20-30 kg/m2
  • treated with multiple insulin injections (at least 4) or insulin pump (continuous subcutaneous insulin infusion [CSII])
  • negative ECG exercise test
  • HbA1c ≤ 8,0%
  • high knowledge about functional insulin therapy, carbohydrate counting and diabetes management during exercise
  • use of advanced glucometer functions and experience in use of Free Style Libre (Flash Glucose Monitoring System, Abbott)

Exclusion criteria

  • HbA1c > 8,0%,
  • advanced complications of diabetes [pre-proliferative or proliferative retinopathy, and previous laser therapy, microalbuminuria or overt nephropathy, autonomic neuropathy (including lack of elevated heart rate during physical activity)]
  • patients physically active (regular physical activities more than once a week),
  • positive ECG exercise test, history of cardiovascular event or coronary heart disease.

Treatment and study plan

Exercise in hypoxia

Behavioral

60 minutes training program of mixed exercise in normobaric hypoxic chamber

Exercise in normoxia

Behavioral

60 minutes training program of mixed exercise in regular air conditions

Primary outcomes

  1. Maximum oxygen consumption (VO2max)

    Time frame: 6 weeks

    measured during Incremental exercise test

  2. Metabolic control of diabetes

    Time frame: 6 weeks

    HbA1c (%,mmol/mol)

  3. Glucose stability

    Time frame: 6 weeks

    Time In Range (TIR, %) while using Continous Glucose Monitoring System

Sponsors and collaborators

Lead sponsor

Silesian Centre for Heart Diseases

Other

Collaborators

  • The Jerzy Kukuczka Academy of Physical Education in Katowice

Registry information

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Jun 30, 2020
Registry last updated
Apr 28, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.