Assessing the impact of physical activity on newly diagnosed type 1 diabetes
Assessment of Physical Effort in People With Newly Diagnosed Type 1 Diabetes Mellitus and Its Impact on: Partial Clinical Remission, Insulin Resistance, HDL Cholesterol Function, Immune Function and Length of Life.
This study is testing how physical activity affects people who have just been diagnosed with type 1 diabetes to see if it helps them manage their condition better over time.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 35 Years |
| Sex | All |
| Sponsor | Poznan University of Medical Sciences Academic / other |
| Locations | 1 site (Poznan) |
| Trial ID | NCT04968171 on ClinicalTrials.gov |
What this trial studies
The Diab1Fit project focuses on evaluating how physical activity affects individuals with newly diagnosed type 1 diabetes. Participants will undergo intensive insulin therapy and will be monitored over a minimum of 5-10 years to assess various health metrics, including VO2max and plasma lipoprotein changes. The study aims to understand the relationship between physical fitness and clinical remission in type 1 diabetes, as well as the underlying mechanisms involved. Regular assessments will occur at multiple intervals to track progress and health outcomes.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 18-35 with newly diagnosed type 1 diabetes who are willing to participate in intensive insulin therapy.
Not a fit: Patients with contraindications to exercise testing or significant co-morbidities may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved management strategies for individuals with type 1 diabetes, enhancing their quality of life and health outcomes.
How similar studies have performed: While there have been studies on physical activity in diabetes management, this specific approach focusing on newly diagnosed type 1 diabetes and its long-term effects is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age 18-35 years, * New onset type 1 diabetes (confirmed by the presence of antibodies - antyGAD, ICA, IA2) * Treatment with intensive insulin therapy, * Written consent to participate in the study. Exclusion Criteria: * Contraindications to the exercise test (including: recent myocardial infarction, unstable coronary artery disease, hypertrophic cardiomyopathy, serious arrhythmias, myocarditis, advanced systemic diseases, hyperthyroidism, recurrent anemia), * Mental disorders, * Co-morbidities with potential impact on physical performance (e.g. cancer, renal failure, liver failure, rheumatic diseases, COPD, asthma, anemia, hypothyroidism and hyperthyroidism), * Pregnancy.
Where this trial is running
Poznan
- Department of Internal Medicine and Diabetiology Poznan University of Medical Sciences — Poznan, Poland (Recruiting)
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.