Hyppää sisältöön
    • Suomeksi
    • In English
  • Suomeksi
  • In English
  • Kirjaudu
Näytä aineisto 
  •   Etusivu
  • 3. UTUCris-artikkelit
  • Rinnakkaistallenteet
  • Näytä aineisto
  •   Etusivu
  • 3. UTUCris-artikkelit
  • Rinnakkaistallenteet
  • Näytä aineisto
JavaScript is disabled for your browser. Some features of this site may not work without it.

INnoVative trial design for testing the Efficacy, Safety and Tolerability of 6-month treatment with incretin-based therapy to prevent type 1 DIAbetes in autoantibody positive participants: A protocol for three parallel double-blind, randomised controlled trials (INVESTDIA)

Veijola Riitta; Kero Jukka; Pokka Tytti; Karsikas Sara; Lou Olivia; Koskenniemi Jaakko J.; Toppari Jorma

INnoVative trial design for testing the Efficacy, Safety and Tolerability of 6-month treatment with incretin-based therapy to prevent type 1 DIAbetes in autoantibody positive participants: A protocol for three parallel double-blind, randomised controlled trials (INVESTDIA)

Veijola Riitta
Kero Jukka
Pokka Tytti
Karsikas Sara
Lou Olivia
Koskenniemi Jaakko J.
Toppari Jorma
Katso/Avaa
Diabetic Medicine - 2022 - Kero - INnoVative trial design for testing the Efficacy Safety and Tolerability of 6‐month.pdf (226.3Kb)
Lataukset: 

WILEY
doi:10.1111/dme.14913
URI
https://onlinelibrary.wiley.com/doi/10.1111/dme.14913
Näytä kaikki kuvailutiedot
Julkaisun pysyvä osoite on:
https://urn.fi/URN:NBN:fi-fe2022091258513
Tiivistelmä

Aims beta-cell stress and dysfunction may contribute to islet autoimmunity and progression to clinical type 1 diabetes. We present a protocol of three randomised controlled trials assessing the effects of glucagon-like peptide 1 (GLP - 1) analogue liraglutide in three early stages of type 1 diabetes.

Methods We will test 10- to 30-year-old people with multiple islet autoantibodies for their glucose metabolism and randomise participants with stage 1 (multiple islet autoantibodies and normoglycaemia), stage 2 (multiple islet autoantibodies and dysglycaemia) and early stage 3 (clinical diagnosis) type 1 diabetes, 10-14 persons in each, to a 6-month intervention with liraglutide or placebo with 6-month follow-up in the stage 2 and stage 3 trials and 18-month follow-up in the stage 1 trial. Primary efficacy outcome in the stage 1 and stage 2 trials is a first-phase insulin response in an intravenous glucose tolerance test and C-peptide area under the curve in a 2-h mixed-meal tolerance test in the stage 3 trial. In addition, safety and tolerability of liraglutide treatment will be assessed.

Conclusions Most prevention trials of type 1 diabetes have targeted the immune system. Treatment with GLP-1 analogue liraglutide supports the pancreatic beta-cells, which should likewise attenuate islet autoimmunity. Our innovative study design allows simultaneous investigation of an intervention in three groups of people who represent various early stages of type 1 diabetes and maximises the eligibility to participate.

Trial registration NCT02611232 (stage 1 trial), NCT02898506 (stage 2 trial), NCT02908087 (stage 3 trial).

Kokoelmat
  • Rinnakkaistallenteet [19207]

Turun yliopiston kirjasto | Turun yliopisto
julkaisut@utu.fi | Tietosuoja | Saavutettavuusseloste
 

 

Tämä kokoelma

JulkaisuajatTekijätNimekkeetAsiasanatTiedekuntaLaitosOppiaineYhteisöt ja kokoelmat

Omat tiedot

Kirjaudu sisäänRekisteröidy

Turun yliopiston kirjasto | Turun yliopisto
julkaisut@utu.fi | Tietosuoja | Saavutettavuusseloste