NCT04450745

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 30, 2019

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

June 21, 2020

Completed
9 days until next milestone

First Posted

Study publicly available on registry

June 30, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2020

Completed
Last Updated

April 28, 2022

Status Verified

April 1, 2022

Enrollment Period

10 months

First QC Date

June 21, 2020

Last Update Submit

April 27, 2022

Conditions

type1diabetes

Outcome Measures

Primary Outcomes (3)

  • 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

Study Arms (2)

Exercise in hypoxia

EXPERIMENTAL

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

Exercise in normoxia

EXPERIMENTAL

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

Behavioral: Exercise in normoxia

Interventions

Exercise in hypoxiaBEHAVIORAL

60 minutes training program of mixed exercise in normobaric hypoxic chamber

Exercise in hypoxia
Exercise in normoxiaBEHAVIORAL

60 minutes training program of mixed exercise in regular air conditions

Exercise in normoxia

Eligibility Criteria

Age30 Years - 45 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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)

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Location

MeSH Terms

Interventions

Exercise

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • 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

    STUDY CHAIR

  • 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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 21, 2020

First Posted

June 30, 2020

Study Start

October 30, 2019

Primary Completion

August 31, 2020

Study Completion

September 30, 2020

Last Updated

April 28, 2022

Record last verified: 2022-04

Locations

PL(1)