Eccentric training in hypoxia with creatine for metabolic control in type 1 diabetes
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
This study is testing if a special type of exercise in low-oxygen conditions, along with creatine supplements, can help people with type 1 diabetes better manage their blood sugar levels and improve their overall health.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 28 (estimated) |
| Ages | 20 Years to 45 Years |
| Sex | Male |
| Sponsor | Silesian Centre for Heart Diseases Academic / other |
| Locations | 1 site (Zabrze, Silesia) |
| Trial ID | NCT06345612 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effects of eccentric training conducted in normobaric hypoxia and normoxia, combined with creatine supplementation, on metabolic control in patients with type 1 diabetes. Participants will undergo a 10-week training program, with sessions held twice a week under the supervision of a personal trainer. The study will assess various outcomes, including glucose stability, HbA1c levels, muscle strength, and VO2max. Participants will be randomly assigned to different training conditions and monitored for their glucose levels throughout the program.
Who should consider this trial
Good fit: Ideal candidates are individuals with type 1 diabetes for at least 10 years, low physical activity levels, and specific HbA1c and BMI criteria.
Not a fit: Patients with advanced diabetes complications or those who are physically active more than once a week may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could improve metabolic control and physical fitness in patients with type 1 diabetes.
How similar studies have performed: While the specific combination of hypoxia and eccentric training in this context may be novel, similar studies have shown positive outcomes with exercise interventions in diabetes management.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Zabrze, Silesia
- 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, Poland (Recruiting)
Study contacts
- Study coordinator: Marta Wróbel, MD,PhD
- Email: mwrobel@sum.edu.pl
- Phone: +46606873060
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.