Effects of probiotics and fibers on markers of nephropathy, inflammation, intestinal barrier dysfunction and endothelial dysfunction in individuals with type 1 diabetes and albuminuria. The ProFOS Study

IF 2.9 3区医学 Q3 ENDOCRINOLOGY & METABOLISM

Journal of diabetes and its complications Pub Date : 2024-10-24 DOI:10.1016/j.jdiacomp.2024.108892

Elisabeth B. Stougaard , Ninna Hahn Tougaard , Suvanjaa Sivalingam , Christian Stevns Hansen , Joachim Størling , Tine Willum Hansen , Marie Frimodt-Møller , Robert E. Steinert , Soheil Varasteh , Per-Henrik Groop , Hanne Salmenkari , Markku J. Lehto , Frederik Persson , Peter Rossing

{"title":"Effects of probiotics and fibers on markers of nephropathy, inflammation, intestinal barrier dysfunction and endothelial dysfunction in individuals with type 1 diabetes and albuminuria. The ProFOS Study","authors":"Elisabeth B. Stougaard , Ninna Hahn Tougaard , Suvanjaa Sivalingam , Christian Stevns Hansen , Joachim Størling , Tine Willum Hansen , Marie Frimodt-Møller , Robert E. Steinert , Soheil Varasteh , Per-Henrik Groop , Hanne Salmenkari , Markku J. Lehto , Frederik Persson , Peter Rossing","doi":"10.1016/j.jdiacomp.2024.108892","DOIUrl":null,"url":null,"abstract":"<div><h3>Aims</h3><div>To estimate whether a mix of pre- and probiotics would strengthen the gut barrier and protect the kidneys in individuals with type 1 diabetes and albuminuria.</div></div><div><h3>Methods</h3><div>Randomized, placebo-controlled, crossover study. Forty-one participants received synbiotic (pre- and probiotics) mix or placebo for 12 weeks with 6 weeks washout. Primary endpoint was change from baseline to end-of-period in UACR. Secondary endpoints were changes in endothelial glycocalyx thickness, inflammatory and intestinal barrier dysfunction markers, glomerular filtration rate (GFR) and ambulatory systolic blood pressure.</div></div><div><h3>Results</h3><div>Thirty-five participants completed the study. Mean age was 58 (SD 10) years, 73 % (<em>n</em> = 30) were male, median UACR was 134 (IQR 63–293) mg/g, estimated GFR was 75 (30) ml/min/1.73m<sup>2</sup>. There was no significant difference in UACR with a mean relative change (CI 95 %) from baseline to end-of-treatment of −3.0 (−18.4; 15.5) % in the synbiotic group and −12.0 (−29.6; 9.6) % in the placebo group with no significant difference between treatment periods (9.37 (−25.2; 44.0) percentage points; <em>p</em> = 0.60). No significant beneficial difference in the secondary end points was demonstrated.</div></div><div><h3>Conclusion</h3><div>Twelve weeks treatment with synbiotic mix had no effect on UACR or on any of the secondary endpoints in subjects with type 1 diabetes and albuminuria.</div></div>","PeriodicalId":15659,"journal":{"name":"Journal of diabetes and its complications","volume":"38 12","pages":"Article 108892"},"PeriodicalIF":2.9000,"publicationDate":"2024-10-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Journal of diabetes and its complications","FirstCategoryId":"3","ListUrlMain":"https://www.sciencedirect.com/science/article/pii/S1056872724002186","RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q3","JCRName":"ENDOCRINOLOGY & METABOLISM","Score":null,"Total":0}

引用次数: 0

Abstract

Aims

To estimate whether a mix of pre- and probiotics would strengthen the gut barrier and protect the kidneys in individuals with type 1 diabetes and albuminuria.

Methods

Randomized, placebo-controlled, crossover study. Forty-one participants received synbiotic (pre- and probiotics) mix or placebo for 12 weeks with 6 weeks washout. Primary endpoint was change from baseline to end-of-period in UACR. Secondary endpoints were changes in endothelial glycocalyx thickness, inflammatory and intestinal barrier dysfunction markers, glomerular filtration rate (GFR) and ambulatory systolic blood pressure.

Results

Thirty-five participants completed the study. Mean age was 58 (SD 10) years, 73 % (n = 30) were male, median UACR was 134 (IQR 63–293) mg/g, estimated GFR was 75 (30) ml/min/1.73m². There was no significant difference in UACR with a mean relative change (CI 95 %) from baseline to end-of-treatment of −3.0 (−18.4; 15.5) % in the synbiotic group and −12.0 (−29.6; 9.6) % in the placebo group with no significant difference between treatment periods (9.37 (−25.2; 44.0) percentage points; p = 0.60). No significant beneficial difference in the secondary end points was demonstrated.

Conclusion

Twelve weeks treatment with synbiotic mix had no effect on UACR or on any of the secondary endpoints in subjects with type 1 diabetes and albuminuria.

查看原文本刊更多论文

益生菌和纤维对 1 型糖尿病和白蛋白尿患者肾病、炎症、肠屏障功能障碍和内皮功能障碍指标的影响。ProFOS 研究

方法随机、安慰剂对照、交叉研究。41 名参与者接受合生元（前体和益生菌）混合物或安慰剂治疗，为期 12 周，其中 6 周为冲洗期。主要终点是 UACR 从基线到期末的变化。次要终点是内皮糖萼厚度、炎症和肠屏障功能障碍标志物、肾小球滤过率（GFR）和非卧床收缩压的变化。平均年龄为 58 (SD 10) 岁，73%（n = 30）为男性，UACR 中位数为 134 (IQR 63-293) mg/g，估计 GFR 为 75 (30) ml/min/1.73m2。从基线到治疗结束，合生元组 UACR 的平均相对变化（CI 95 %）为 -3.0 (-18.4; 15.5) %，安慰剂组为 -12.0 (-29.6; 9.6) %，治疗期间无明显差异（9.37 (-25.2; 44.0) 个百分点；P = 0.60）。结论对患有白蛋白尿的 1 型糖尿病患者来说，使用合生元组合进行为期 12 周的治疗对 UACR 或任何次要终点均无影响。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

求助全文

约1分钟内获得全文求助全文

来源期刊

Journal of diabetes and its complications 医学-内分泌学与代谢

CiteScore

5.90

自引率

3.30%

发文量

153

审稿时长

16 days

期刊介绍： Journal of Diabetes and Its Complications (JDC) is a journal for health care practitioners and researchers, that publishes original research about the pathogenesis, diagnosis and management of diabetes mellitus and its complications. JDC also publishes articles on physiological and molecular aspects of glucose homeostasis. The primary purpose of JDC is to act as a source of information usable by diabetes practitioners and researchers to increase their knowledge about mechanisms of diabetes and complications development, and promote better management of people with diabetes who are at risk for those complications. Manuscripts submitted to JDC can report any aspect of basic, translational or clinical research as well as epidemiology. Topics can range broadly from early prediabetes to late-stage complicated diabetes. Topics relevant to basic/translational reports include pancreatic islet dysfunction and insulin resistance, altered adipose tissue function in diabetes, altered neuronal control of glucose homeostasis and mechanisms of drug action. Topics relevant to diabetic complications include diabetic retinopathy, neuropathy and nephropathy; peripheral vascular disease and coronary heart disease; gastrointestinal disorders, renal failure and impotence; and hypertension and hyperlipidemia.