Reducing cardiometabolic risk with semaglutide in type 1 diabetes (RESET1): Study protocol of a phase 2 double-blinded randomised placebo-controlled trial.

Autor: Frampton R; Clinical Diabetes and Metabolism, Garvan Institute of Medical Research, Darlinghurst, New South Wales, Australia.; St Vincent's Clinical Campus, Faculty of Medicine and Health, University of New South Wales, Sydney, New South Wales, Australia.; Department of Diabetes and Endocrinology, St Vincent's Hospital Sydney, Darlinghurst, New South Wales, Australia.; Department of Diabetes and Endocrinology, The Canberra Hospital, Garran, Australian Capital Territory, Australia., Snaith JR; Clinical Diabetes and Metabolism, Garvan Institute of Medical Research, Darlinghurst, New South Wales, Australia.; St Vincent's Clinical Campus, Faculty of Medicine and Health, University of New South Wales, Sydney, New South Wales, Australia.; Department of Diabetes and Endocrinology, St Vincent's Hospital Sydney, Darlinghurst, New South Wales, Australia., Hocking S; Charles Perkins Centre, Sydney Medical School, The University of Sydney, New South Wales, Australia., Holmes-Walker J; Westmead Clinical School, Sydney Medical School, The University of Sydney, Westmead, New South Wales, Australia., Olsen N; Stats Central, University of New South Wales, Sydney, New South Wales, Australia., Greenfield JR; Clinical Diabetes and Metabolism, Garvan Institute of Medical Research, Darlinghurst, New South Wales, Australia.; St Vincent's Clinical Campus, Faculty of Medicine and Health, University of New South Wales, Sydney, New South Wales, Australia.; Department of Diabetes and Endocrinology, St Vincent's Hospital Sydney, Darlinghurst, New South Wales, Australia.
Jazyk: angličtina
Zdroj: Diabetic medicine : a journal of the British Diabetic Association [Diabet Med] 2024 Jun 09, pp. e15377. Date of Electronic Publication: 2024 Jun 09.
DOI: 10.1111/dme.15377
Abstrakt: Background: Premature cardiovascular disease is the leading cause of death in people living with type 1 diabetes. Therapies are urgently needed to address cardiovascular risk in this group. Semaglutide, a long-acting glucagon-like peptide-1 receptor agonist, has been shown to reduce cardiovascular events and improve weight and glycaemia in type 2 diabetes. Semaglutide may offer cardioprotective and metabolic benefits in type 1 diabetes.
Methods: We will study 60 adults aged 25-70 years with type 1 diabetes of duration at least 2 years, body mass index ≥25 kg/m 2 , HbA 1c ≥7% and at least one cardiovascular risk factor (microalbuminuria, hypertension or anti-hypertensive treatment, hyperlipidemia or lipid lowering therapy, current smoking). Participants will receive semaglutide up to 1.0 mg weekly or matched placebo for 26 weeks. The primary outcome is carotid femoral pulse wave velocity, a measure of arterial stiffness, as a surrogate marker of cardiovascular risk. Potential mechanisms for metabolic changes will be explored including change in insulin sensitivity determined by hyperinsulinaemic-euglycaemic clamp; and incretin and pancreatic hormone action measured during mixed meal tolerance test.
Conclusion: The REducing cardiometabolic risk with SEmaglutide in Type 1 diabetes study will investigate whether semaglutide, a long acting glucagon-like peptide receptor agonist, can improve markers of cardiometabolic health in T1D. Underlying mechanisms predicting response, including insulin resistance and incretin hormone status, will also be explored.
(© 2024 The Author(s). Diabetic Medicine published by John Wiley & Sons Ltd on behalf of Diabetes UK.)
Databáze: MEDLINE
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