Ignite Creation Date:
2024-05-06 @ 8:21 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06345612
Status:
RECRUITING
Last Update Posted:
2024-04-03
First Post:
2024-02-23
Brief Title:
Impact of Eccentric Training in Hypoxia With Creatine on Metabolic Control and VO2max in Patients With Type 1 Diabetes
Sponsor:
Silesian Centre for Heart Diseases
Organization:
Silesian Centre for Heart Diseases
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Detailed Description:
People with type 1 diabetes benefit from training in normobaric hypoxia - the composition of the air in the training room is 154 oxygen 847 nitrogen which corresponds to hypoxia at an altitude of 2500 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 albumincreatinine 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
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 albumincreatinine 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None