Efficacy of Jiedu Tongluo Tiaogan Formula on Type 2 Diabetic Lower Extremity Arteriosclerosis Obliterans: Study Protocol for a Metabolomics-Based Randomized Controlled Clinical Trial

Abstract

Introduction: Diabetic lower extremity arteriosclerosis obstruction (DLASO) is a common macrovascular complication in type 2 diabetic mellitus (T2DM), which can cause amputations and a higher risk of cardiovascular events. However, there are few effective treatments for DLASO currently. To evaluate the safety and efficacy of Jiedu Tongluo Tiaogan Formula (JTTF) in type 2 diabetic lower extremity arteriosclerosis obliterans and looking for a mechanism of action, we designed a clinical trial and mechanism exploration based on metabolomics technology. Methods and Analysis: This study is designed as a randomized controlled clinical trial. A total of 80 participants will be recruited and randomized to a TCM group (JTTF + essential treatments) and a control group (essential treatments) in a ratio of 1:1. The treatment duration is 12 weeks. Changes in clinical symptom scores, color ultrasound Doppler hemodynamics of lower extremity arteries, and Ankle-Brachial Ratio (ABI) will be the primary outcomes. Changes in TCM symptoms scores, other indicators related to arteriosclerosis, blood glucose, lipids, and body mass will be the secondary outcomes. The primary and secondary outcomes will be evaluated at baseline and week 12. Safety outcomes and adverse events will also be properly assessed. After treatment completion, blood and urine samples from subjects will be tested for metabolomics. Discussion: This study aims to verify the efficacy and safety of JTTF in type 2 diabetic lower extremity arteriosclerosis obliterans and obtain the key action pathway. It helps to provide scientific evidence for TCM treatment of diabetic vascular complications. Ethics and Dissemination: This trial has been approved by the Ethics Committee (GZYLL(KY)-2021-024). Results of this trial will be published in journals and presented at scientific conferences. We share raw data in the ResMan network platform. All the authors declare that they have no conflicts of interest. Trial registration: Chinese Clinical Trials Register, ChiCTR2100051337. Registered on 20 September 2021.

Competing Interest Statement

The authors have declared no competing interest.

Clinical Trial

ChiCTR2100051337

Funding Statement

This study was supported by the National Natural Science Foundation of China (grant number: 81973813), the Scientific research project of Traditional Chinese Medicine Bureau of Guangdong Province (grant number: 20221329), and Shenzhen Science and Technology Innovation Program (grant number: JCY20190809110015528). The funder was not involved in the study design, collection, analysis, interpretation of data, the writing of this article, or the decision to submit it for publication.

Author Declarations

I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained.

Yes

The details of the IRB/oversight body that provided approval or exemption for the research described are given below:

Ethics committee (Shenzhen Hospital (Futian) of Guangzhou University of Chinese Medicine) gave ethical approval for this work. The approval number is GZYLL(KY)-2021-024.

I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals.

Yes

I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance).

Yes

I have followed all appropriate research reporting guidelines and uploaded the relevant EQUATOR Network research reporting checklist(s) and other pertinent material as supplementary files, if applicable.

Yes

Data Availability

All data produced in the present study are available upon reasonable request to the authors All data produced in the present work are contained in the manuscript All data produced are available online at the ResMan network platform (https://www.chictr.org.cn/edit.aspx?pid=134097&htm=4).

https://www.chictr.org.cn/edit.aspx?pid=134097&htm=4

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