Diabetes Type 1 and Fitness.

NCT04968171 | Unknown

• 1 other identifier: 1050/19
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus

Keywords

Diabetes mellitus type 1; Physical activity; Clinical remission

Outcome Measures

Primary Outcomes (2)

• VO2max [ml/min/kg]

  VO2 max level evaluated during ergospirometry (COSMED K5)

  1 year

• Partial clinical remission time

  Presence \[(4 x insulin dose (j/kg/d)\] ≤ 9\] and duration \[time\] of partial clinical remission

  1 year

Secondary Outcomes (12)

• Triglicerydes concentriation in serum [mg/dl]

  Change from baseline in apolipoproteins' at 6 and 12 months

• LDL-C concentriation in serum [mg/dl]

  Change from baseline in apolipoproteins' at 6 and 12 months

• HDL-C concentriation in serum [mg/dl]

  Change from baseline in apolipoproteins' at 6 and 12 months

• Total Cholesterol concentriation in serum [mg/dl]

  Change from baseline in apolipoproteins' at 6 and 12 months

• Lipid tissue content [%]

  5 years

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Poznan University of Medical Sciences: lead

Study Sites (1)

Department of Internal Medicine and Diabetiology Poznan University of Medical Sciences

Poznan, 60-834, Poland

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus; Diabetes Mellitus, Type 1; Motor Activity

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases; Behavior

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 13, 2020
• First Posted: July 20, 2021
• Study Start: January 1, 2020
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2025
• Last Updated: July 20, 2021

Record last verified: 2021-07

Locations

PL (1)