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

type1diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04450745
• Other study ID #: Hypoxia-DiabetesT1
• Status: Completed
• Phase: N/A
• Start date: October 30, 2019
• Est. completion date: September 30, 2020

Study information

• Verified date: April 2022
• Source: Silesian Centre for Heart Diseases
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: September 30, 2020
• Est. primary completion date: August 31, 2020
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 30 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hypoxia
• type1diabetes

Intervention

Behavioral:
• Exercise in hypoxia
60 minutes training program of mixed exercise in normobaric hypoxic chamber
• Exercise in normoxia
60 minutes training program of mixed exercise in regular air conditions

Locations

Country	Name	City	State
Poland	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	Silesia

Sponsors (2)

Lead Sponsor	Collaborator
Silesian Centre for Heart Diseases	The Jerzy Kukuczka Academy of Physical Education in Katowice

Country where clinical trial is conducted

Poland, 

Outcome

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