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Diabetes MellitusDiab1FitNCT04968171

Diabetes Type 1 and Fitness.

An observational study of Diabetes Mellitus, run by Poznan University of Medical Sciences at 1 site in Poland.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 35 years
Conditions the study is for
Diabetes Mellitus
How many people
100 participants
Where
1 sitePoland
Study dates
1 Jan 2020to 31 Dec 2025
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 35 years
  • All sexes
  • No healthy volunteers
  • Adult

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.

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Poland1 site, 1 recruiting
  • Department of Internal Medicine and Diabetiology Poznan University of Medical Sciences

    Poznan, 60-834

    Justyna Flotyńska, 728328961 ext. +48, justynaflotynska@gmail.com

    Aleksandra Uruska, PhD, 607620750 ext. +48, aleksandrauruska@gmail.com

    Recruiting

Other trials in Poland

About this study

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.

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.

Read the detailed description

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.

Patients will be assessed: during the first hospitalization in the moment of diagnosis (prior to introduction of insulin treatment), after 3 weeks, after 6 months and after 12 months of insulin therapy. Further observations planned in the annual intervals. Further continuous observation with follow-up every year and evaluation of final end-points after 5 and 10 years. In addition, the study group will be under constant monitoring of metabolic evaluation every three months in the Outpatient Clinic. An additional visit to assess VO2max will be scheduled between 3 and 12 months of diabetes. The investigators will use an ergospirometer (COSMED K5 System) during an exercise test carried out on a cycloergometer (progressive exercise test). Moreover, the investigators will monitor glucose levels during the exercise test - using a continuous glucose monitoring system using the FreeStyle Libre Flash Glucose Monitoring System (Abbott). A week before the exercise test, the investigators will borrow a Garmin watch that assesses the patient's daily activities

During each follow-up will be assessed parameters:

  1. The presence of partial clinical remission, according to Mortensen: HbA1c (%) + [4 x dawka insuliny (j/kg/d)] ≤ 9.
  2. Data on lifestyle (diet, exercise), family history and smoking.
  3. Anthropometric data:
  4. BMI (body mass index) = weight [kg]/(height [m])2
  5. Waist circumference
  6. WHR - waist to hip ratio
  7. daily insulin requirement (U/kg m.c./d),
  8. eGDR (estimated glucose disposal rate) = 24.31-12.22(WHR)-3.29(hypertension 0/1)-0.57( HbA1c [mg/kg/min])
  9. VAI (visceral adiposity index): For women = [Waist circumference/36.58+(1.89xBMI)]x(TG/0.81)x(1.52/HDL), For men = [Waist circumference /39.68+(1.88xBMI)]x(TG/1.03)x(1.31/HDL),
  10. body composition analysis
  11. Parameters of diabetes metabolic control
  12. Lipid profile
  13. Glycated hemoglobin level (HbA1c)
  14. Protein glycation end products Expected impact of the research project on the development of science, civilization and society: The study confirms the great importance of aerobic physical activity in the treatment of people with DM1 from the beginning of the diagnosis. The project aims to pay attention to the importance of physical activity among people with DM1 and to popularize this method of treatment. The obtained results will be used for the prospective observation of this group to assess the impact of physical effort on the development of chronic complications and will allow planning intervention studies in this population. The results of this study will help enrich knowledge about the body's ability to exercise among people with DM1 and show new intervention solutions. It may contribute to changing the recommendations of scientific societies. What is more knowledge about prolonging partial clinical remission and thereby reducing the risk of developing chronic complications will contribute to the introduction of new recommendations. Research on exercise in diabetes and longevity proteins will increase the length and quality of life of people with DM1.
Keywords
Diabetes mellitus type 1, Physical activity, Clinical remission
Medical subject headings
Diabetes Mellitus, Diabetes Mellitus, Type 1, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT04968171
Study groupRoleWhat they receive
People with newly diagnosed diabetes mellitus type 1People 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. VO2max [ml/min/kg]

    VO2 max level evaluated during ergospirometry (COSMED K5)

    Measured: 1 year

  2. Partial clinical remission time

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

    Measured: 1 year

Secondary outcomes (12)
  1. Triglicerydes concentriation in serum [mg/dl]

    Changes in serum triglyceride levels

    Measured: Change from baseline in apolipoproteins' at 6 and 12 months

  2. LDL-C concentriation in serum [mg/dl]

    Changes in serum LDL levels

    Measured: Change from baseline in apolipoproteins' at 6 and 12 months

  3. HDL-C concentriation in serum [mg/dl]

    Changes in serum HDL levels

    Measured: Change from baseline in apolipoproteins' at 6 and 12 months

  4. Total Cholesterol concentriation in serum [mg/dl]

    Changes in serum Total-CH levels

    Measured: Change from baseline in apolipoproteins' at 6 and 12 months

  5. Lipid tissue content [%]

    Evaluation of lipid tissue content prior to yearly visit.

    Measured: 5 years

  6. A1c [%]

    Changes in serum A1c levels

    Measured: 5 years

  7. Daily insulin requirement [u/kg/d]

    Sum of insulin units administered in the day prior to yearly visit.

    Measured: 1 year

  8. Retinopathy

    Evaluation of retinopathy (ophthalmology assessment)

    Measured: 5 years

  9. Neuropathy

    Evaluation of presence of neuropathy peripheral and autonomic (clinical examination, Visual Analog Score for pain and ProsciCard)

    Measured: 5 years

  10. eGFR [ml/min/1,73m2]

    Assessment of glomerular filtration and renal filtration function

    Measured: 5 years

  11. Creatynine [mg/dl]

    Assessment of renal function

    Measured: 5 years

  12. Albumine to creatynine ratio ACR [mg/g]

    Assessment of renal function

    Measured: 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Jul 2021
  2. Study start1 Jan 2020
  3. Primary completion31 Dec 2022 (estimated)
  4. Study completion31 Dec 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Prospective
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04968171
Sponsor's protocol ID
1050/19
Acronym
Diab1Fit
Status last verified
Jul 2021
First submitted
13 Aug 2020
Last updated
20 Jul 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Diabetes Mellitus, run by Poznan University of Medical Sciences at 1 site in Poland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 20 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

VO2max [ml/min/kg] (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2021.

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