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.

Study Overview

• Status: Completed
• Conditions: type1diabetes
• Intervention / Treatment: Behavioral: Exercise in hypoxia; Behavioral: Exercise in normoxia

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.

• Study Type: Interventional
• Enrollment (Actual): 16
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Poland
  • Silesia
    • Zabrze, Silesia, Poland, 41-800
      • 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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 45 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Exercise in hypoxia; Patients randomized to this arm will have training program in normobaric hypoxic chamber 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)	Behavioral: Exercise in hypoxia; 60 minutes training program of mixed exercise in normobaric hypoxic chamber
EXPERIMENTAL: Exercise in normoxia; Patients randomized to this arm will have the same training program in normoxic conditions	Behavioral: Exercise in normoxia; 60 minutes training program of mixed exercise in regular air conditions

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maximum oxygen consumption (VO2max)	measured during Incremental exercise test	6 weeks
Metabolic control of diabetes	HbA1c (%,mmol/mol)	6 weeks
Glucose stability	Time In Range (TIR, %) while using Continous Glucose Monitoring System	6 weeks

Collaborators and Investigators

• Sponsor: Silesian Centre for Heart Diseases
• Collaborators: The Jerzy Kukuczka Academy of Physical Education in Katowice
• Investigators: Study Chair: Krzysztof Strojek, Professor, 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; Principal Investigator: Marta Wróbel, PhD, 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

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 30, 2019
• Primary Completion (ACTUAL): August 31, 2020
• Study Completion (ACTUAL): September 30, 2020

Study Registration Dates

• First Submitted: June 21, 2020
• First Submitted That Met QC Criteria: June 24, 2020
• First Posted (ACTUAL): June 30, 2020

Study Record Updates

• Last Update Posted (ACTUAL): April 28, 2022
• Last Update Submitted That Met QC Criteria: April 27, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Signs and Symptoms, Respiratory; Hypoxia
• Other Study ID Numbers: Hypoxia-DiabetesT1

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No