Impact of Eccentric Training in Hypoxia With Creatine on Metabolic Control and VO2max in Patients With Type 1 Diabetes
NCT ID: NCT06345612
Last Updated: 2024-04-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
28 participants
INTERVENTIONAL
2023-11-15
2025-07-31
Brief Summary
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Detailed Description
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Before starting the10 - week training program all participants will undergo preliminary examination by a cardiologist during which echocardiography and ECG will be conducted. Then the incremental exercise test and muscle strength test will be performed to determine aerobic capacity (VO2max) and select individual weights to train for each participant.
Patients enrolled to the study will be randomly assigned to one of the following 2 groups (training under normoxia or hypoxia conditions) and subgroups (with and without supplementation of creatine).
Randomization will be carried out in blocks of 4 people.
Training sessions will take place with the assistance of a personal trainer in the Hypoxia Laboratory and the Muscle Strength and Power Laboratory of Academy of Physical Education in Katowice twice a week for 60 minutes for a period of 10 weeks. The subjects will complete the same eccentric training program with individually selected weights.
Within whole training period glucose level will be monitored via Flash Glucose Monitoring system (Free Style Libre2). During training sessions concentration of asprosin, irisin, GH, IGF-1 within blood serum immediately before and afrer the first and last training will be assessed.
At baseline and after 10 weeks blood count, ALT, AST, creatinine, GFR, HbA1c, ACR (albumin/creatinine ratio) in a random urine sample, body weight, BMI, waist-hip circumference, body composition, quality of life according to the EQ-Worksheet questionnaire, daily insulin requirement, incremental exercise test, muscle strength test (1RM) will be investigated among all participants.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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1. exercise in hypoxia with creatine supplementation
* training program in normobaric hypoxic chamber set to contain equivalent to an altitude of 2500 meters above sea level (indoor air composition: 15,4% of O2 and 84,7% of N)
* with creatine supplementation
hypoxia
eccentric training program conducted within normobaric hypoxic chamber
creatine supplementation
5g of creatine per day
2. exercise in hypoxia without creatine supplementation
* training program in normobaric hypoxic chamber set to contain equivalent to an altitude of 2500 meters above sea level (indoor air composition: 15,4% of O2 and 84,7% of N)
* without creatine supplementation
hypoxia
eccentric training program conducted within normobaric hypoxic chamber
no creatine supplementation
no creatine supplementation
3. exercise in normoxia with creatine supplementation
* the same training program in normoxic conditions
* with creatine supplementation
normoxia
eccentric training program conducted within normoxic conditions
creatine supplementation
5g of creatine per day
4.exercise in normoxia without creatine supplementation
* the same training program in normoxic conditions
* without creatine supplementation
normoxia
eccentric training program conducted within normoxic conditions
no creatine supplementation
no creatine supplementation
Interventions
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hypoxia
eccentric training program conducted within normobaric hypoxic chamber
normoxia
eccentric training program conducted within normoxic conditions
creatine supplementation
5g of creatine per day
no creatine supplementation
no creatine supplementation
Eligibility Criteria
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Inclusion Criteria
* low physical activity,
* BMI:20-31 kg/m2,
* treated with multiple insulin injections (at least 4 daily) 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,
* experience in use of FreeStyleLibre2 (Flash Glucose Monitoring System, Abbott),
* Informed consent to participate in research signed by enrolled subjects
Exclusion Criteria
* 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
20 Years
45 Years
MALE
No
Sponsors
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Silesian Centre for Heart Diseases
OTHER
Responsible Party
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Principal Investigators
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Krzysztof Strojek, Prof.
Role: STUDY_CHAIR
Medical University of Silesia in Katowice
Locations
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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, Poland
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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Hypoxia-Exercise-DiabetesT1
Identifier Type: -
Identifier Source: org_study_id
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