Effects of rosuvastatin/ezetimibe on senescence of CD8+ T-cell in type 2 diabetic patients with hypercholesterolemia: A study protocol.
Medicine (Baltimore)
; 101(47): e31691, 2022 Nov 25.
Article
en En
| MEDLINE
| ID: mdl-36451471
ABSTRACT
BACKGROUND:
A decade ago, systemic inflammation became widely recognized as an etiology of type 2 diabetes mellitus (T2DM) and complications thereof. Senescent CD8â +â T cells of T2DM patients exhibit increased secretion of pro-inflammatory cytokines and enhanced expression of cytotoxic molecules, contributing to systemic inflammation. Recently, many anti-inflammatory roles played by statins and ezetimibe (cholesterol-lowering drugs) have been reported. We will explore the effects of statin/ezetimibe therapy on CD8â +â T cell senescence in patients with T2DM and hypercholesterolemia.METHODS:
This 2-group, parallel, randomized, controlled clinical trial will recruit 108 subjects with T2DM and low-density lipoprotein-cholesterol (LDL-C) levelsâ ≥100 mg/dL and randomly assign them to rosuvastatin/ezetimibe and rosuvastatin groups at a 11 ratio. Blood samples will be drawn at baseline and after 12 weeks of medication. The primary outcomes will be the LDL-C-lowering effects after 12 weeks. The secondary outcomes will be changes in the senescent (CD28â -â CD57+) CD8â +â T cell proportions; the levels of circulating pro-inflammatory cytokines, cytotoxic molecules, interleukin-1, transforming growth factor-ß, fasting glucose, and HbA1c; and biochemical indices of kidney, liver, and muscle function. Symptoms and signs of predictable adverse events (myopathy and hepatitis) will be routinely monitored.DISCUSSION:
We will evaluate the effects of statin/ezetimibe on CD8â +â T cell senescence. Statin/ezetimibe may exert a beneficial immunomodulatory effect.
Texto completo:
1
Base de datos:
MEDLINE
Asunto principal:
Inhibidores de Hidroximetilglutaril-CoA Reductasas
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Diabetes Mellitus Tipo 2
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Hipercolesterolemia
Tipo de estudio:
Clinical_trials
/
Prognostic_studies
Límite:
Humans
Idioma:
En
Revista:
Medicine (Baltimore)
Año:
2022
Tipo del documento:
Article