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Diabetes Type 1 and Fitness. (Diab1Fit)

7. Juli 2021 aktualisiert von: Poznan University of Medical Sciences

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.

Studienübersicht

Status

Rekrutierung

Bedingungen

Detaillierte Beschreibung

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:

    1. BMI (body mass index) = weight [kg]/(height [m])2
    2. Waist circumference
    3. WHR - waist to hip ratio
    4. daily insulin requirement (U/kg m.c./d),
    5. eGDR (estimated glucose disposal rate) = 24.31-12.22(WHR)-3.29(hypertension 0/1)-0.57( HbA1c [mg/kg/min])
    6. 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),

    7. body composition analysis
  4. Parameters of diabetes metabolic control

    1. Lipid profile
    2. Glycated hemoglobin level (HbA1c)
  5. 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.

Studientyp

Beobachtungs

Einschreibung (Voraussichtlich)

100

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

      • Poznan, Polen, 60-834
        • Rekrutierung
        • Department of Internal Medicine and Diabetiology Poznan University of Medical Sciences
        • Kontakt:
        • Kontakt:

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

18 Jahre bis 35 Jahre (Erwachsene)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Probenahmeverfahren

Nicht-Wahrscheinlichkeitsprobe

Studienpopulation

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.

Beschreibung

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.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Beobachtungsmodelle: Nur Fall
  • Zeitperspektiven: Interessent

Kohorten und Interventionen

Gruppe / Kohorte
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.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
VO2max [ml/min/kg]
Zeitfenster: 1 year
VO2 max level evaluated during ergospirometry (COSMED K5)
1 year
Partial clinical remission time
Zeitfenster: 1 year
Presence [(4 x insulin dose (j/kg/d)] ≤ 9] and duration [time] of partial clinical remission
1 year

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Triglicerydes concentriation in serum [mg/dl]
Zeitfenster: Change from baseline in apolipoproteins' at 6 and 12 months
Changes in serum triglyceride levels
Change from baseline in apolipoproteins' at 6 and 12 months
LDL-C concentriation in serum [mg/dl]
Zeitfenster: Change from baseline in apolipoproteins' at 6 and 12 months
Changes in serum LDL levels
Change from baseline in apolipoproteins' at 6 and 12 months
HDL-C concentriation in serum [mg/dl]
Zeitfenster: Change from baseline in apolipoproteins' at 6 and 12 months
Changes in serum HDL levels
Change from baseline in apolipoproteins' at 6 and 12 months
Total Cholesterol concentriation in serum [mg/dl]
Zeitfenster: Change from baseline in apolipoproteins' at 6 and 12 months
Changes in serum Total-CH levels
Change from baseline in apolipoproteins' at 6 and 12 months
Lipid tissue content [%]
Zeitfenster: 5 years
Evaluation of lipid tissue content prior to yearly visit.
5 years
A1c [%]
Zeitfenster: 5 years
Changes in serum A1c levels
5 years
Daily insulin requirement [u/kg/d]
Zeitfenster: 1 year
Sum of insulin units administered in the day prior to yearly visit.
1 year
Retinopathy
Zeitfenster: 5 years
Evaluation of retinopathy (ophthalmology assessment)
5 years
Neuropathy
Zeitfenster: 5 years
Evaluation of presence of neuropathy peripheral and autonomic (clinical examination, Visual Analog Score for pain and ProsciCard)
5 years
eGFR [ml/min/1,73m2]
Zeitfenster: 5 years
Assessment of glomerular filtration and renal filtration function
5 years
Creatynine [mg/dl]
Zeitfenster: 5 years
Assessment of renal function
5 years
Albumine to creatynine ratio ACR [mg/g]
Zeitfenster: 5 years
Assessment of renal function
5 years

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

1. Januar 2020

Primärer Abschluss (Voraussichtlich)

31. Dezember 2022

Studienabschluss (Voraussichtlich)

31. Dezember 2025

Studienanmeldedaten

Zuerst eingereicht

13. August 2020

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

7. Juli 2021

Zuerst gepostet (Tatsächlich)

20. Juli 2021

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

20. Juli 2021

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

7. Juli 2021

Zuletzt verifiziert

1. Juli 2021

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Produkt, das in den USA hergestellt und aus den USA exportiert wird

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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