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

Primary Purpose

type1diabetes

Status
Completed
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
Exercise in hypoxia
Exercise in normoxia
Sponsored by
Silesian Centre for Heart Diseases
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for type1diabetes

Eligibility Criteria

30 Years - 45 Years (Adult)MaleDoes not accept healthy volunteers

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.

Sites / Locations

  • 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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Exercise in hypoxia

Exercise in normoxia

Arm Description

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)

Patients randomized to this arm will have the same training program in normoxic conditions

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
June 21, 2020
Last Updated
April 27, 2022
Sponsor
Silesian Centre for Heart Diseases
Collaborators
The Jerzy Kukuczka Academy of Physical Education in Katowice
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1. Study Identification

Unique Protocol Identification Number
NCT04450745
Brief Title
Physical Exercise in Normobaric Hypoxia and Normoxia in Type 1 Diabetic Patients
Official Title
Physical Exercise in Normobaric Hypoxia and Normoxia in Type 1 Diabetic Patients
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
October 30, 2019 (Actual)
Primary Completion Date
August 31, 2020 (Actual)
Study Completion Date
September 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Silesian Centre for Heart Diseases
Collaborators
The Jerzy Kukuczka Academy of Physical Education in Katowice

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
type1diabetes

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Exercise in hypoxia
Arm Type
Experimental
Arm Description
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)
Arm Title
Exercise in normoxia
Arm Type
Experimental
Arm Description
Patients randomized to this arm will have the same training program in normoxic conditions
Intervention Type
Behavioral
Intervention Name(s)
Exercise in hypoxia
Intervention Description
60 minutes training program of mixed exercise in normobaric hypoxic chamber
Intervention Type
Behavioral
Intervention Name(s)
Exercise in normoxia
Intervention Description
60 minutes training program of mixed exercise in regular air conditions
Primary Outcome Measure Information:
Title
Maximum oxygen consumption (VO2max)
Description
measured during Incremental exercise test
Time Frame
6 weeks
Title
Metabolic control of diabetes
Description
HbA1c (%,mmol/mol)
Time Frame
6 weeks
Title
Glucose stability
Description
Time In Range (TIR, %) while using Continous Glucose Monitoring System
Time Frame
6 weeks

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Krzysztof Strojek, Professor
Organizational Affiliation
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
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Marta Wróbel, PhD
Organizational Affiliation
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
Official's Role
Principal Investigator
Facility Information:
Facility Name
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
City
Zabrze
State/Province
Silesia
ZIP/Postal Code
41-800
Country
Poland

12. IPD Sharing Statement

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

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