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Insulin Therapy and Lipoproteins' Profile in Type 1 Diabetes. (InLipoDiab1)

2. maj 2020 opdateret af: Aleksandra Uruska, Poznan University of Medical Sciences

Insulin Therapy and Quantitive and Qualitive Changes of Plasma Lipoproteins in Patients With Newly Diagnosed Type 1 Diabetes.

The aim of the study is to evaluate the effect of insulin therapy in patients with newly diagnosed type 1 diabetes on quantitative and qualitative changes of plasma lipoproteins, with particular emphasis on HDL metabolism, and analysis of the factors determining the effect of insulin therapy on lipid profile.The study is planned to cover a minimum of 100 people with newly diagnosed type 1 diabetes and lead prospective observation of this group (for a minimum of 5-10 years). 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. In addition, the study group will be under constant monitoring of metabolic evaluation every three months in the Outpatient Clinic.

During each follow-up will be assessed parameters evaluating the metabolism of plasma lipoprotein fractions and subfractions of HDL:

  1. The concentration of apolipoprotein: including A-I, A-II, A-IV, C (II and III), D and E
  2. Electrophoresis of plasma lipoproteins
  3. Electrophoresis of HDL
  4. The activity of enzymes: acyltransferase lecithin: cholesterol (LCAT) and plasma lipoprotein lipase Moreover, evaluation of factors which may potentially modify the relation between insulin therapy and lipoproteins will be assessed

    1. Anthropometric data and markers of insulin resistance (such as BMI, waist-hip ratio, the estimated rate of glucose distribution, VAI index, body fat, blood pressure),
    2. Metabolic management of diabetes,,
    3. Protein glycation end products
    4. The concentration of plasma adipokines.

Expected impact of the research project on the development of science, civilization and society The obtained results allow to assess the impact of exogenous insulin on quantitative and qualitative changes and metabolism of lipoproteins in the serum of patients with type 1 diabetes. Understanding the etiopathogenesis of this phenomenon and the factors affecting it seem to be very important in the treatment of patients with type 1 diabetes, where insulin is the treatment of choice and dosage adjustment appears to be extremely important. Remains unknown whether the changes in the lipoprotein profile result from the beginning of insulin therapy or other factors influence it. Selecting a group of patients with less favorable lipoprotein profile may allow better metabolic control, and thus will affect the quality and length of life of our patients. These studies will assess the impact of our therapeutic actions on the diagnosis of the disease on long-term consequences, such as the development of chronic complications.

Studieoversigt

Status

Rekruttering

Undersøgelsestype

Observationel

Tilmelding (Forventet)

300

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Undersøgelse Kontakt Backup

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 35 år (Voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Sandsynlighedsprøve

Studiebefolkning

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

Beskrivelse

Inclusion Criteria:

  • New onset type 1 diabetes and treatment with insulin.
  • Written consent to participate in the study.
  • There are no other medical conditions, and with no other additional drugs beyond insulin

Exclusion Criteria:

  • any other medical conditions, and any other additional drugs beyond insulin

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Observationsmodeller: Kun etui
  • Tidsperspektiver: Fremadrettet

Kohorter og interventioner

Gruppe / kohorte
Type 1 diabetic patients
Newly diagnosed diabetes type 1 admitted to the Department of Internal Medicine and Diabetology. Measurement of lipid profile and lipoproteins before and after administration of insulin. Further continuous observation with follow-up every year and evaluation of final end-points after 5 and 10 years.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Changes in lipoproteins' metabolism
Tidsramme: Change from Baseline in lipoproteins' metabolism at 6 and 12 months
Evaluation of HDL levels, subfractions and enzymes connected with HDL metabolism (LCAT, lipoprotein lipase)
Change from Baseline in lipoproteins' metabolism at 6 and 12 months
Factors influencing relationship between insulin treatment and lipoproteins
Tidsramme: 1 year
Metabolic control, presence of remission, insulin resistance, adipokines, daily insulin requirement
1 year

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Changes in apolipoproteins
Tidsramme: Change from baseline in apolipoproteins' at 6 and 12 months
Evaluation of apolipoproteins: A-I, A-II, A-IV, C (II i III), D i E
Change from baseline in apolipoproteins' at 6 and 12 months
Presence of insulin resistance
Tidsramme: 1 year
Evaluation of lipid tissue content, VAI, triglycerides/HDL ratio and estimated glucose disposal rate
1 year
Development of Retinopathy
Tidsramme: 1 year
Evaluation of retinopathy (ophthalmology assessment)
1 year
Development of Neuropathy
Tidsramme: 1 year
Evaluation of presence of neuropathy peripheral and autonomic (clinical examination and ProsciCard)
1 year
Development of Diabetic kidney disease
Tidsramme: 1 year
Evaluation of presence of diabetic kidney disease (albuminuria, GFR)
1 year

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. november 2014

Primær færdiggørelse (Forventet)

1. december 2022

Studieafslutning (Forventet)

1. januar 2023

Datoer for studieregistrering

Først indsendt

23. november 2014

Først indsendt, der opfyldte QC-kriterier

29. november 2014

Først opslået (Skøn)

3. december 2014

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

5. maj 2020

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

2. maj 2020

Sidst verificeret

1. maj 2020

Mere information

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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