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

Type 1 Diabetes Clinical Trial

Official 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06345612
• Other study ID #: Hypoxia-Exercise-DiabetesT1
• Status: Recruiting
• Phase: N/A
• Start date: November 15, 2023
• Est. completion date: July 2025

Study information

• Verified date: February 2024
• Source: Silesian Centre for Heart Diseases
• Contact: Marta Wróbel, MD,PhD
• Phone: +46606873060
• Email: mwrobel[@]sum.edu.pl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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 the hypoxia-inducible transcription factor HIF-1, 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, 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 28
• Est. completion date: July 2025
• Est. primary completion date: June 2025
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 20 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Hypoxia
• Type 1 Diabetes

Intervention

Behavioral:
• hypoxia
eccentric training program conducted within normobaric hypoxic chamber
• normoxia
eccentric training program conducted within normoxic conditions

Dietary Supplement:
• creatine supplementation
5g of creatine per day
• no creatine supplementation
no creatine supplementation

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 (1)

Lead Sponsor	Collaborator
Silesian Centre for Heart Diseases

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Metabolic control of diabetes	HbA1c (%, mmol/mol)	before and after 10 weeks
Primary	Time in range	TIR- percentage of time with blood glucose in a target range: 70-180 mg/dl (%)	before and after 10 weeks
Primary	Time below range	TBR - percentage of time with blood glucose levels<70 mg/dl (%)	before and after 10 weeks
Primary	Maximum oxygen consumption (VO2max)	measured during incremental exercise test	before and after 10 weeks