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Diabetes Type 1 and Fitness. (Diab1Fit)

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ClinicalTrials.gov Identifier: NCT04968171
Recruitment Status : Recruiting
First Posted : July 20, 2021
Last Update Posted : July 20, 2021
Sponsor:
Information provided by (Responsible Party):
Poznan University of Medical Sciences

Brief Summary:
The Diab1Fit Study project aims to a multidirectional assessment of physical activity and its impact in people with type 1 diabetes (DM1). To the study are recruited people with newly diagnosed DM1, treated with intensive functional insulin therapy from the beginning of the disease. The study is planned to cover a minimum of 100 people with newly diagnosed DM1 and lead prospective observation of this group (for a minimum of 5-10 years). The investigators will evaluate the effect of VO2max in people with newly diagnosed DM1 on partial clinical remission. What is more the investigators also assess quantitative and qualitative changes of plasma lipoproteins, with particular emphasis on HDL metabolism, mechanism linking VO2max with management of DM1 (longevity proteins, miostatin, insulin resistance) and immune function.

Condition or disease
Diabetes Mellitus

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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: 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.
Actual Study Start Date : January 1, 2020
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : December 31, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1

Group/Cohort
People with newly diagnosed diabetes mellitus type 1

People with newly diagnosed diabetes mellitus type 1 admitted to the Department of Internal Medicine and Diabetology.

Treated with intensive insulin therapy. Measurement of VO2max between 3 and 12 month after diagnosis. Further continuous observation with follow-up every year and evaluation of final end-points after 5 and 10 years.




Primary Outcome Measures :
  1. VO2max [ml/min/kg] [ Time Frame: 1 year ]
    VO2 max level evaluated during ergospirometry (COSMED K5)

  2. Partial clinical remission time [ Time Frame: 1 year ]
    Presence [(4 x insulin dose (j/kg/d)] ≤ 9] and duration [time] of partial clinical remission


Secondary Outcome Measures :
  1. Triglicerydes concentriation in serum [mg/dl] [ Time Frame: Change from baseline in apolipoproteins' at 6 and 12 months ]
    Changes in serum triglyceride levels

  2. LDL-C concentriation in serum [mg/dl] [ Time Frame: Change from baseline in apolipoproteins' at 6 and 12 months ]
    Changes in serum LDL levels

  3. HDL-C concentriation in serum [mg/dl] [ Time Frame: Change from baseline in apolipoproteins' at 6 and 12 months ]
    Changes in serum HDL levels

  4. Total Cholesterol concentriation in serum [mg/dl] [ Time Frame: Change from baseline in apolipoproteins' at 6 and 12 months ]
    Changes in serum Total-CH levels

  5. Lipid tissue content [%] [ Time Frame: 5 years ]
    Evaluation of lipid tissue content prior to yearly visit.

  6. A1c [%] [ Time Frame: 5 years ]
    Changes in serum A1c levels

  7. Daily insulin requirement [u/kg/d] [ Time Frame: 1 year ]
    Sum of insulin units administered in the day prior to yearly visit.

  8. Retinopathy [ Time Frame: 5 years ]
    Evaluation of retinopathy (ophthalmology assessment)

  9. Neuropathy [ Time Frame: 5 years ]
    Evaluation of presence of neuropathy peripheral and autonomic (clinical examination, Visual Analog Score for pain and ProsciCard)

  10. eGFR [ml/min/1,73m2] [ Time Frame: 5 years ]
    Assessment of glomerular filtration and renal filtration function

  11. Creatynine [mg/dl] [ Time Frame: 5 years ]
    Assessment of renal function

  12. Albumine to creatynine ratio ACR [mg/g] [ Time Frame: 5 years ]
    Assessment of renal function



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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
A minimum of 100 people with newly diagnosed type 1 diabetes hospitalized in the Department of Internal Medicine and Diabetology Poznan University of Medical Sciences.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04968171


Locations
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Poland
Department of Internal Medicine and Diabetiology Poznan University of Medical Sciences Recruiting
Poznan, Poland, 60-834
Contact: Justyna Flotyńska    728328961 ext +48    justynaflotynska@gmail.com   
Contact: Aleksandra Uruska, PhD    607620750 ext +48    aleksandrauruska@gmail.com   
Sponsors and Collaborators
Poznan University of Medical Sciences
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Responsible Party: Poznan University of Medical Sciences
ClinicalTrials.gov Identifier: NCT04968171    
Other Study ID Numbers: 1050/19
First Posted: July 20, 2021    Key Record Dates
Last Update Posted: July 20, 2021
Last Verified: July 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Poznan University of Medical Sciences:
Diabetes mellitus type 1
Physical activity
Clinical remission
Additional relevant MeSH terms:
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Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases