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Completed

NCT Number: NCT06345612

Impact of Eccentric Training in Hypoxia With Creatine on Metabolic Control and VO2max in Patients With Type 1 Diabetes

Exercise plays an important role in treatment of diabetes. In recent years exercise training in normobaric hypoxia is used in training programs for athletes and in rehabilitation and also commercially. The aim of the study is to assess the impact of eccentric training conducted in conditions of normobaric hypoxia or normoxia and creatine supplementation on metabolic control: profile and stability of glucose concentration, HbA1c value, hypoglycemia and insulin demand, as well as the level of muscle strength, VO2max and anthropometric parameters

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Key information

Age range

20 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

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

About this study

People with type 1 diabetes benefit from training in normobaric hypoxia - the composition of the air in the training room is: 15.4% oxygen 84.7% nitrogen, which corresponds to hypoxia at an altitude of 2,500 m above sea level. Hypoxia leads to the production of HIF-1 (hypoxia-inducible transcription factor ), which is a regulator of the expression of many genes responsible for angiogenesis, muscle hypertrophy and glucose stability.

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 (protein hormone encoded by the C-terminal region of the FBN1 gene, which encodes fibrillin-1 protein), irisin, GH (growth hormone), IGF-1 (Insulin-like growth factor-1) within blood serum immediately before and after the first and last training will be assessed.

At baseline and after 10 weeks blood count, Alanine aminotransferase (ALT), Aspartate aminotransferase (AST), creatinine, GFR (glomerular filtration rate), 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-5D-5L (EuroQol Five-Dimension Five-Level scale), daily insulin requirement, incremental exercise test, muscle strength test (10RM-10 repetition maximum) will be investigated among all participants.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • type 1 diabetes of at least 10 years duration,
  • 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

  • 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

Treatment and study plan

hypoxia

Behavioral

eccentric training program conducted within normobaric hypoxic chamber

normoxia

Behavioral

eccentric training program conducted within normoxic conditions

creatine supplementation

Dietary Supplement

5g of creatine per day

no creatine supplementation

Dietary Supplement

no creatine supplementation

Primary outcomes

  1. Metabolic control of diabetes

    Time frame: before and after 10 weeks

    HbA1c (%, mmol/mol)

  2. Time in range (TIR)

    Time frame: before and after 10 weeks

    TIR- percentage of time with blood glucose in a target range: 70-180 mg/dl (%)

  3. Time below range (TBR)

    Time frame: before and after 10 weeks

    TBR - percentage of time with blood glucose levels<70 mg/dl (%)

  4. Maximum oxygen consumption (VO2max)

    Time frame: before and after 10 weeks

    measured during incremental exercise test

Sponsors and collaborators

Lead sponsor

Silesian Centre for Heart Diseases

Other

Registry information

Official study title

Impact of Eccentric Training Conducted in the Conditions of Normobaric Hypoxia, Normoxia and Creatine Supplementation on Metabolic Control, Muscle Strength Level, Maximum Oxygen Consumption (VO2max) in Patients With Type 1diabetes Mellitus

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Apr 3, 2024
Registry last updated
May 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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