Cargando…
Effects of α lipoic acid combined with olmesartan medoxomil on blood glucose and oxidation indicators in patients with diabetic nephropathy: A protocol for a parallel, randomized, double-blind, controlled clinical trial
BACKGROUND: Diabetic nephropathy (DN) is a common microvascular complication of diabetes, which poses a serious threat to the health and life of patients. There is evidence that both α lipoic acid and olmesartan medoxomil have positive effects in the treatment of DN, but whether the 2 have synergist...
Autores principales: | , , , , |
---|---|
Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Lippincott Williams & Wilkins
2022
|
Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9276178/ https://www.ncbi.nlm.nih.gov/pubmed/35512068 http://dx.doi.org/10.1097/MD.0000000000029080 |
_version_ | 1784745660883402752 |
---|---|
author | Jiao, Shengfu Dong, Yuxia Chang, Xiang Wu, Yanan Li, Haifeng |
author_facet | Jiao, Shengfu Dong, Yuxia Chang, Xiang Wu, Yanan Li, Haifeng |
author_sort | Jiao, Shengfu |
collection | PubMed |
description | BACKGROUND: Diabetic nephropathy (DN) is a common microvascular complication of diabetes, which poses a serious threat to the health and life of patients. There is evidence that both α lipoic acid and olmesartan medoxomil have positive effects in the treatment of DN, but whether the 2 have synergistic effects and the effects on blood glucose and oxidation indicators are controversial. METHODS: This is a prospective parallel, randomized, double-blind, placebo-controlled trial to study the effects of α lipoic acid in combination with olmesartan medoxomil on blood glucose and oxidation indicators in patients with DN. Participants will be randomly assigned to a treatment group, which will receive α lipoic acid dispersive tablets combined with olmesartan medoxomil tablets, or a control group, which will receive olmesartan medoxomil tablets combined with placebo for 4 weeks, followed up for 12 weeks. Observation indicators include: glycemic indicators [fasting blood glucose, 2 hours postprandial blood glucose and glycosylated hemoglobin], the oxidation indicators [serum glutathione, superoxide dismutase, malondialdehyde, 8-hydroxydeox-yguanosine], and adverse reactions. Finally, SPASS 22.0 software will be used for statistical analysis of the data. DISCUSSION: This study will evaluate the effects of α lipoic acid combined with olmesartan medoxomil on blood glucose and oxidation indicators in patients with DN. The results of this study will provide a reference for the clinical use of α lipoic acid combined with olmesartan medoxomil in the treatment of DN. TRIAL REGISTRATION: OSF Registration number: DOI 10.17605/OSF.IO/VJWXS |
format | Online Article Text |
id | pubmed-9276178 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2022 |
publisher | Lippincott Williams & Wilkins |
record_format | MEDLINE/PubMed |
spelling | pubmed-92761782022-07-13 Effects of α lipoic acid combined with olmesartan medoxomil on blood glucose and oxidation indicators in patients with diabetic nephropathy: A protocol for a parallel, randomized, double-blind, controlled clinical trial Jiao, Shengfu Dong, Yuxia Chang, Xiang Wu, Yanan Li, Haifeng Medicine (Baltimore) 5200 BACKGROUND: Diabetic nephropathy (DN) is a common microvascular complication of diabetes, which poses a serious threat to the health and life of patients. There is evidence that both α lipoic acid and olmesartan medoxomil have positive effects in the treatment of DN, but whether the 2 have synergistic effects and the effects on blood glucose and oxidation indicators are controversial. METHODS: This is a prospective parallel, randomized, double-blind, placebo-controlled trial to study the effects of α lipoic acid in combination with olmesartan medoxomil on blood glucose and oxidation indicators in patients with DN. Participants will be randomly assigned to a treatment group, which will receive α lipoic acid dispersive tablets combined with olmesartan medoxomil tablets, or a control group, which will receive olmesartan medoxomil tablets combined with placebo for 4 weeks, followed up for 12 weeks. Observation indicators include: glycemic indicators [fasting blood glucose, 2 hours postprandial blood glucose and glycosylated hemoglobin], the oxidation indicators [serum glutathione, superoxide dismutase, malondialdehyde, 8-hydroxydeox-yguanosine], and adverse reactions. Finally, SPASS 22.0 software will be used for statistical analysis of the data. DISCUSSION: This study will evaluate the effects of α lipoic acid combined with olmesartan medoxomil on blood glucose and oxidation indicators in patients with DN. The results of this study will provide a reference for the clinical use of α lipoic acid combined with olmesartan medoxomil in the treatment of DN. TRIAL REGISTRATION: OSF Registration number: DOI 10.17605/OSF.IO/VJWXS Lippincott Williams & Wilkins 2022-05-06 /pmc/articles/PMC9276178/ /pubmed/35512068 http://dx.doi.org/10.1097/MD.0000000000029080 Text en Copyright © 2022 the Author(s). Published by Wolters Kluwer Health, Inc. https://creativecommons.org/licenses/by/4.0/This is an open access article distributed under the Creative Commons Attribution License 4.0 (CCBY), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. http://creativecommons.org/licenses/by/4.0 (https://creativecommons.org/licenses/by/4.0/) |
spellingShingle | 5200 Jiao, Shengfu Dong, Yuxia Chang, Xiang Wu, Yanan Li, Haifeng Effects of α lipoic acid combined with olmesartan medoxomil on blood glucose and oxidation indicators in patients with diabetic nephropathy: A protocol for a parallel, randomized, double-blind, controlled clinical trial |
title | Effects of α lipoic acid combined with olmesartan medoxomil on blood glucose and oxidation indicators in patients with diabetic nephropathy: A protocol for a parallel, randomized, double-blind, controlled clinical trial |
title_full | Effects of α lipoic acid combined with olmesartan medoxomil on blood glucose and oxidation indicators in patients with diabetic nephropathy: A protocol for a parallel, randomized, double-blind, controlled clinical trial |
title_fullStr | Effects of α lipoic acid combined with olmesartan medoxomil on blood glucose and oxidation indicators in patients with diabetic nephropathy: A protocol for a parallel, randomized, double-blind, controlled clinical trial |
title_full_unstemmed | Effects of α lipoic acid combined with olmesartan medoxomil on blood glucose and oxidation indicators in patients with diabetic nephropathy: A protocol for a parallel, randomized, double-blind, controlled clinical trial |
title_short | Effects of α lipoic acid combined with olmesartan medoxomil on blood glucose and oxidation indicators in patients with diabetic nephropathy: A protocol for a parallel, randomized, double-blind, controlled clinical trial |
title_sort | effects of α lipoic acid combined with olmesartan medoxomil on blood glucose and oxidation indicators in patients with diabetic nephropathy: a protocol for a parallel, randomized, double-blind, controlled clinical trial |
topic | 5200 |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9276178/ https://www.ncbi.nlm.nih.gov/pubmed/35512068 http://dx.doi.org/10.1097/MD.0000000000029080 |
work_keys_str_mv | AT jiaoshengfu effectsofalipoicacidcombinedwitholmesartanmedoxomilonbloodglucoseandoxidationindicatorsinpatientswithdiabeticnephropathyaprotocolforaparallelrandomizeddoubleblindcontrolledclinicaltrial AT dongyuxia effectsofalipoicacidcombinedwitholmesartanmedoxomilonbloodglucoseandoxidationindicatorsinpatientswithdiabeticnephropathyaprotocolforaparallelrandomizeddoubleblindcontrolledclinicaltrial AT changxiang effectsofalipoicacidcombinedwitholmesartanmedoxomilonbloodglucoseandoxidationindicatorsinpatientswithdiabeticnephropathyaprotocolforaparallelrandomizeddoubleblindcontrolledclinicaltrial AT wuyanan effectsofalipoicacidcombinedwitholmesartanmedoxomilonbloodglucoseandoxidationindicatorsinpatientswithdiabeticnephropathyaprotocolforaparallelrandomizeddoubleblindcontrolledclinicaltrial AT lihaifeng effectsofalipoicacidcombinedwitholmesartanmedoxomilonbloodglucoseandoxidationindicatorsinpatientswithdiabeticnephropathyaprotocolforaparallelrandomizeddoubleblindcontrolledclinicaltrial |