Eman M Ghonaim, Osama M Ibrahim, Sahar K Hegazy, Wael F Farrag, Hytham R Badr
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Secondary outcomes included fasting insulin, serum interleukin-6 (IL-6), high mobility group box 1 (HMGB-1), asprosin, and malondialdehyde (MDA). All outcomes were measured at baseline and after three months.</p><p><strong>Results: </strong>A between-groups comparison revealed significantly lower inflammatory markers with NTZ compared to control [IL-6: 23.64 ng/L (21.00-32.71) vs. 32.52 ng/L (29.63-36.13) and HMGB-1: 10.46 ng/mL (6.37-14.61) vs. 22.60 ng/mL (20.18-27.37), P < 0.001 for both]. HbA1c, fasting blood glucose, insulin, asprosin, and MDA were not considerably different between the two groups. Markedly lower levels of IL-6 (P = 0.009), HMGB-1 (P < 0.001), asprosin, (P = 0.002), and MDA (P < 0.001) were observed following NTZ treatment. Conversely, IL-6 and HMGB-1 increased significantly in the control group (P < 0.001 for both). Other biomarkers did not change significantly in both groups.</p><p><strong>Conclusion: </strong>NTZ may alleviate oxidative stress and inflammation in type 2 diabetes despite no improvement in glycemic parameters.</p><p><strong>Trial registration: </strong>This trial is registered on ClinicalTrials.gov under the name: Nitazoxanide as Adjuvant Therapy in Type 2 Diabetes Mellitus with the identifier: NCT06010992. 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引用次数: 0
摘要
目的：临床前数据表明硝唑尼特（nitazoxanide， NTZ）是一种潜在的PPAR-γ激动剂，对2型糖尿病有潜在的益处。该试点试验旨在探讨NTZ作为现有二甲双胍-维格列汀联合治疗的附加治疗对2型糖尿病患者血糖控制和炎症生物标志物的耐受性和初步影响。方法：对对照组和NTZ组88例患者（每组44例）进行分析。所有患者均采用二甲双胍-维格列汀联合治疗。NTZ组给予硝唑尼特500 mg口服，每日2次。主要终点是血糖控制，通过糖化血红蛋白（HbA1c）和空腹血糖来评估。次要结局包括空腹胰岛素、血清白介素-6 （IL-6）、高流动性组盒1 （HMGB-1）、阿斯丁蛋白酶和丙二醛（MDA）。在基线和三个月后测量所有结果。结果：组间比较显示，与对照组相比，NTZ组炎症指标明显降低[IL-6: 23.64 ng/L (21.00-32.71) vs. 32.52 ng/L（29.63-36.13）和HMGB-1: 10.46 ng/mL (6.37-14.61) vs. 22.60 ng/mL (20.18-27.37)]， P结论：NTZ可减轻2型糖尿病的氧化应激和炎症，但血糖参数没有改善。试验注册：该试验在ClinicalTrials.gov上注册，名称为：Nitazoxanide作为2型糖尿病的辅助治疗，标识符为：NCT06010992。报名日期：8-2023年。
Repurposing nitazoxanide in type 2 diabetes mellitus: a randomized controlled trial.
Objective: Preclinical data suggest nitazoxanide (NTZ) as a potential PPAR-γ agonist with potential benefits in type 2 diabetes. This pilot trial aimed to explore the tolerability and preliminary effects of NTZ as an add-on therapy to the existing metformin-vildagliptin combination on glycemic control and inflammatory biomarkers in type 2 diabetes patients.
Methods: Eighty-eight patients were analyzed in the control and NTZ groups (44 per group). All patients were treated with metformin-vildagliptin combination. The NTZ group received 500 mg nitazoxanide orally twice daily. The primary outcome was glycemic control, assessed by glycated hemoglobin (HbA1c) and fasting blood glucose. Secondary outcomes included fasting insulin, serum interleukin-6 (IL-6), high mobility group box 1 (HMGB-1), asprosin, and malondialdehyde (MDA). All outcomes were measured at baseline and after three months.
Results: A between-groups comparison revealed significantly lower inflammatory markers with NTZ compared to control [IL-6: 23.64 ng/L (21.00-32.71) vs. 32.52 ng/L (29.63-36.13) and HMGB-1: 10.46 ng/mL (6.37-14.61) vs. 22.60 ng/mL (20.18-27.37), P < 0.001 for both]. HbA1c, fasting blood glucose, insulin, asprosin, and MDA were not considerably different between the two groups. Markedly lower levels of IL-6 (P = 0.009), HMGB-1 (P < 0.001), asprosin, (P = 0.002), and MDA (P < 0.001) were observed following NTZ treatment. Conversely, IL-6 and HMGB-1 increased significantly in the control group (P < 0.001 for both). Other biomarkers did not change significantly in both groups.
Conclusion: NTZ may alleviate oxidative stress and inflammation in type 2 diabetes despite no improvement in glycemic parameters.
Trial registration: This trial is registered on ClinicalTrials.gov under the name: Nitazoxanide as Adjuvant Therapy in Type 2 Diabetes Mellitus with the identifier: NCT06010992. Registration date: 8-2023.
期刊介绍：
Well-established as a major journal in today’s rapidly advancing experimental and clinical research areas, Endocrine publishes original articles devoted to basic (including molecular, cellular and physiological studies), translational and clinical research in all the different fields of endocrinology and metabolism. Articles will be accepted based on peer-reviews, priority, and editorial decision. Invited reviews, mini-reviews and viewpoints on relevant pathophysiological and clinical topics, as well as Editorials on articles appearing in the Journal, are published. Unsolicited Editorials will be evaluated by the editorial team. Outcomes of scientific meetings, as well as guidelines and position statements, may be submitted. The Journal also considers special feature articles in the field of endocrine genetics and epigenetics, as well as articles devoted to novel methods and techniques in endocrinology.
Endocrine covers controversial, clinical endocrine issues. Meta-analyses on endocrine and metabolic topics are also accepted. Descriptions of single clinical cases and/or small patients studies are not published unless of exceptional interest. However, reports of novel imaging studies and endocrine side effects in single patients may be considered. Research letters and letters to the editor related or unrelated to recently published articles can be submitted.
Endocrine covers leading topics in endocrinology such as neuroendocrinology, pituitary and hypothalamic peptides, thyroid physiological and clinical aspects, bone and mineral metabolism and osteoporosis, obesity, lipid and energy metabolism and food intake control, insulin, Type 1 and Type 2 diabetes, hormones of male and female reproduction, adrenal diseases pediatric and geriatric endocrinology, endocrine hypertension and endocrine oncology.
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