AI Article Synopsis
- The study aims to evaluate the effects of the GLP-1 analogue liraglutide on β-cell stress and its potential impact on islet autoimmunity in early stages of type 1 diabetes.
- Participants aged 10 to 30 with multiple islet autoantibodies will be randomized into three groups based on the early stages of type 1 diabetes, receiving either liraglutide or a placebo for 6 to 18 months.
- The research seeks to assess the safety and effectiveness of liraglutide, with a focus on enhancing pancreatic β-cell function, and aims to provide insights that differ from previous studies by targeting both immune response and pancreatic support.
Article Abstract
Aims: β-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 β-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).
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|---|---|
| http://www.ncbi.nlm.nih.gov/pmc/articles/PMC9540026 | PMC |
| http://dx.doi.org/10.1111/dme.14913 | DOI Listing |
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