Effects of Ezetimibe/Simvastatin and Rosuvastatin on Oxidative Stress in Diabetic Neuropathy: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial

Objective. To evaluate the effects of ezetimibe/simvastatin (EZE/SIMV) and rosuvastatin (ROSUV) on oxidative stress (OS) markers in patients with diabetic polyneuropathy (DPN).Methods. We performed a randomized, double-blind, placebo-controlled phase III clinical trial in adult patients with Type 2 Diabetes Mellitus (T2DM) and DPN, as evaluated by composite scores and nerve conduction studies (NCS). Seventy-four subjects with T2DM were allocated 1 : 1 : 1 to placebo, EZE/SIMV 10/20 mg, or ROSUV 20 mg for 16 weeks. All patients were assessed before and after treatment: primary outcomes were lipid peroxidation (LPO), and nitric oxide (NO) surrogate levels in plasma; secondary outcomes included NCS, neuropathic symptom scores, and metabolic parameters. Data were expressed as mean ± SD or SEM, frequencies, and percentages; we used nonparametric analysis.Results. LPO levels were reduced in both statin arms after 16 weeks of treatment (p<0.05versus baseline), without changes in the placebo group. NO levels were not significantly affected by statin treatment, although a trend towards significance concerning increased NO levels was noted in both statin arms. No significant changes were observed for the NCS or composite scores.Discussion. EZE/SIMV and ROSUV are superior to placebo in reducing LPO in subjects with T2DM suffering from polyneuropathy. This trial is registered withNCT02129231.

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Effects of a Single Oral Megadose of Vitamin D3 on Inflammation and Oxidative Stress Markers in Overweight and Obese Women: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial

Diabetes Metabolic Syndrome and Obesity Targets and Therapy ◽

10.2147/dmso.s285597 ◽

2021 ◽

Vol Volume 14 ◽

pp. 525-534

Author(s):

Laine de Carvalho Guerra Pessoa Mamede ◽

Rafaela Lira Formiga Cavalcanti de Lima ◽

Alexandre Sérgio Silva ◽

João Carlos Lima Rodrigues Pita ◽

Nadjeanny Ingrid Galdino Gomes ◽

...

Keyword(s):

Oxidative Stress ◽

Clinical Trial ◽

Vitamin D3 ◽

Controlled Clinical Trial ◽

Oxidative Stress Markers ◽

Obese Women ◽

Double Blind ◽

Double Blind Placebo ◽

Stress Markers ◽

And Oxidative Stress

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The effects of resveratrol on markers of oxidative stress in patients with type 2 diabetes: a randomized, double-blind, placebo-controlled clinical trial

Acta Diabetologica ◽

10.1007/s00592-017-1098-3 ◽

2018 ◽

Vol 55 (4) ◽

pp. 341-353 ◽

Cited By ~ 44

Author(s):

ShadiSadat Seyyedebrahimi ◽

Hadi Khodabandehloo ◽

Ensieh Nasli Esfahani ◽

Reza Meshkani

Keyword(s):

Oxidative Stress ◽

Type 2 Diabetes ◽

Clinical Trial ◽

Controlled Clinical Trial ◽

Double Blind ◽

Double Blind Placebo ◽

Markers Of Oxidative Stress

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Evaluation of the Effects ofVaccinium arctostaphylosL. Fruit Extract on Serum Lipids and hs-CRP Levels and Oxidative Stress in Adult Patients with Hyperlipidemia: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial

Evidence-based Complementary and Alternative Medicine ◽

10.1155/2014/217451 ◽

2014 ◽

Vol 2014 ◽

pp. 1-6 ◽

Cited By ~ 21

Author(s):

Rasool Soltani ◽

Mustafa Hakimi ◽

Sedigheh Asgary ◽

Syed Mustafa Ghanadian ◽

Mahtab Keshvari ◽

...

Keyword(s):

Oxidative Stress ◽

Clinical Trial ◽

Serum Levels ◽

Adult Patients ◽

Controlled Clinical Trial ◽

Fruit Extract ◽

Double Blind ◽

Double Blind Placebo ◽

Hs Crp ◽

And Oxidative Stress

Background.Dyslipidemia produces atherosclerosis, which in turn results in coronary artery disease (CAD). Atherosclerosis is being considered as an inflammatory disease.Vaccinium arctostaphylosL. is a plant with fruits rich in anthocyanins. The aim of this study was to evaluate the effects of fruit extract of this plant on serum levels of lipids, hs-CRP, and malondialdehyde (MDA) as a marker of oxidative stress, in hyperlipidemic adult patients.Methods.In this randomized, double-blind, placebo-controlled clinical trial, 50 hyperlipidemic adult patients were randomly and equally assigned to receive either medicinal (V. arctostaphylosfruit extract) or placebo capsules twice daily for 4 weeks. Each medicinal capsule contained 45 ± 2 mg of anthocyanins. Fasting serum levels of total cholesterol, TG, LDL-C, HDL-C, hs-CRP, and MDA were obtained before and after the intervention and compared.Results. V. arctostaphylosfruit extract significantly reduced total cholesterol (P<0.001), LDL-C (P=0.004), TG (P<0.001), and MDA (P=0.013) compared to placebo but did not have any significant effect on HDL-C (P=0.631) and hs-CRP (P=0.190).Conclusion.Fruit extract ofVaccinium arctostaphyloshas beneficial effects on serum lipid profile and oxidative stress in hyperlipidemic adult patients. Therefore, it could be considered as a supplement for treatment of dyslipidemia and prevention of atherosclerosis development.

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