Evidence-Based Complementary and Alternative Medicine

Volume 2021, Issue 1 6006802

Research Article

Open Access

Prevention of Diabetes in Overweight/Obese Adults through Traditional Chinese Patent Medicine: Study Protocol for a Prospective Cohort Study

Bing Pang

orcid.org/0000-0002-0069-5055

Department of Endocrinology, Guang’ Anmen Hospital of China Academy of Chinese Medical Sciences, Beijing, China min-saude.pt

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Yue-Ying Zhang,

Yue-Ying Zhang

orcid.org/0000-0002-5197-4126

Department of Endocrinology, Guang’ Anmen Hospital of China Academy of Chinese Medical Sciences, Beijing, China min-saude.pt

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Hua-Jie Hu,

Hua-Jie Hu

orcid.org/0000-0003-2079-5317

Department of Endocrinology, Beijing Shunyi District Hospital of Chinese Medicine, Beijing, China min-saude.pt

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Ye Sun,

Ye Sun

orcid.org/0000-0002-6448-6623

Department of Endocrinology, Beijing Pinggu District Hospital of Chinese Medicine, Beijing, China min-saude.pt

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Ai-Mei Cao,

Ai-Mei Cao

orcid.org/0000-0002-3128-5622

Department of Endocrinology, Beijing Changping District Hospital of Chinese Medicine, Beijing, China min-saude.pt

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Chun-Qian Lu,

Chun-Qian Lu

orcid.org/0000-0001-6908-1951

Department of Endocrinology, Beijing Miyun District Hospital of Chinese Medicine, Beijing, China min-saude.pt

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Wei-Hua Zhang,

Wei-Hua Zhang

orcid.org/0000-0001-8686-1597

Department of Endocrinology, Beijing Shijitan Hospital, Capital Medical University, Beijing, China ccmu.edu.cn

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Qing Ni,

Corresponding Author

Qing Ni

[email protected]

orcid.org/0000-0002-4786-4901

Department of Endocrinology, Guang’ Anmen Hospital of China Academy of Chinese Medical Sciences, Beijing, China min-saude.pt

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Bing Pang,

Bing Pang

orcid.org/0000-0002-0069-5055

Department of Endocrinology, Guang’ Anmen Hospital of China Academy of Chinese Medical Sciences, Beijing, China min-saude.pt

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Yue-Ying Zhang,

Yue-Ying Zhang

orcid.org/0000-0002-5197-4126

Department of Endocrinology, Guang’ Anmen Hospital of China Academy of Chinese Medical Sciences, Beijing, China min-saude.pt

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Hua-Jie Hu,

Hua-Jie Hu

orcid.org/0000-0003-2079-5317

Department of Endocrinology, Beijing Shunyi District Hospital of Chinese Medicine, Beijing, China min-saude.pt

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Ye Sun,

Ye Sun

orcid.org/0000-0002-6448-6623

Department of Endocrinology, Beijing Pinggu District Hospital of Chinese Medicine, Beijing, China min-saude.pt

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Ai-Mei Cao,

Ai-Mei Cao

orcid.org/0000-0002-3128-5622

Department of Endocrinology, Beijing Changping District Hospital of Chinese Medicine, Beijing, China min-saude.pt

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Chun-Qian Lu,

Chun-Qian Lu

orcid.org/0000-0001-6908-1951

Department of Endocrinology, Beijing Miyun District Hospital of Chinese Medicine, Beijing, China min-saude.pt

Search for more papers by this author

Wei-Hua Zhang,

Wei-Hua Zhang

orcid.org/0000-0001-8686-1597

Department of Endocrinology, Beijing Shijitan Hospital, Capital Medical University, Beijing, China ccmu.edu.cn

Search for more papers by this author

Qing Ni,

Corresponding Author

Qing Ni

[email protected]

orcid.org/0000-0002-4786-4901

Department of Endocrinology, Guang’ Anmen Hospital of China Academy of Chinese Medical Sciences, Beijing, China min-saude.pt

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First published: 08 November 2021

https://doi.org/10.1155/2021/6006802

Academic Editor: Mohamed Z.M. Salem

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Abstract

Background. Early intervention in prediabetes can prevent or delay the incidence of type 2 diabetes mellitus (T2DM). Traditional Chinese patent medicine (TCPM) is widely used in China to prevent T2DM. This study aims to evaluate the efficacy and safety of TCPMs for preventing T2DM. Method/Design. This study is a multicenter, cohort study with two arms. A total of 600 participants will be recruited. The participants will be divided into either intervention or control groups according to their own desire, and the exposure factor is the application of TCPMs. All participants will be encouraged to lead a healthy lifestyle, and the intervention group also used TCPMs based on syndrome differentiation. Incident diabetes and normalization of blood glucose are indexes of end point. Safety assessments and adverse event monitoring will also be conducted. The treatment duration is set for 24 weeks, and we will follow-up for another 2 years. Discussion. This trial may provide initial evidence regarding the efficacy and safety of TCPMs plus lifestyle intervention (LI) compared to LI alone for preventing T2DM and provide a comprehensive intervention plans that choose suitable TCPMs for diabetes prevention according to syndrome differentiation. Trial Registration Number. Chinese Clinical Trial Registry ID: ChiCTR1900023541, registered on 1 Jun 2019. The version identifier is 2018121702.

Conflicts of Interest

The authors declare no conflicts of interest.

Open Research

Data Availability

Once the main findings of the project are published, the trial steering committee will review all requests for data before access is granted. If appropriate, the anonymized data and associated documentation will be made available to users under a data-sharing agreement.

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Prevention of Diabetes in Overweight/Obese Adults through Traditional Chinese Patent Medicine: Study Protocol for a Prospective Cohort Study

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Prevention of Diabetes in Overweight/Obese Adults through Traditional Chinese Patent Medicine: Study Protocol for a Prospective Cohort Study

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