Basis and Design of a Randomized Clinical Trial to Evaluate the Effect of Jinlida Granules on Metabolic Syndrome in Patients With Abnormal Glucose Metabolism.

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  • Additional Information
    • Source:
      Publisher: Frontiers Research Foundation] Country of Publication: Switzerland NLM ID: 101555782 Publication Model: eCollection Cited Medium: Print ISSN: 1664-2392 (Print) Linking ISSN: 16642392 NLM ISO Abbreviation: Front Endocrinol (Lausanne) Subsets: MEDLINE
    • Publication Information:
      Original Publication: [Lausanne : Frontiers Research Foundation]
    • Subject Terms:
      Biomarkers/*analysis ; Drugs, Chinese Herbal/*therapeutic use ; Glucose Intolerance/*complications ; Metabolic Syndrome/*drug therapy; Adolescent ; Adult ; Aged ; Blood Glucose/analysis ; China ; Double-Blind Method ; Female ; Follow-Up Studies ; Humans ; Male ; Metabolic Syndrome/etiology ; Metabolic Syndrome/pathology ; Middle Aged ; Prognosis ; Research Design ; Young Adult
    • Abstract:
      Background: Metabolic syndrome (MS) is a powerful risk factor for cardiovascular and cerebrovascular diseases. Although lifestyle intervention reduces several of the symptoms of the syndrome and cardiovascular risks, the lifestyle intervention that yields the benefits is restrictive. Jinlida is a Chinese patent medicine that has shown activity in type 2 diabetes, which has been approved in China. Preclinical studies in Jinlida granules support an improved role of abnormal glucose and lipids metabolism as well as reducing weight. Here, we describe the protocol of an ongoing clinical trial investigating a new therapy for metabolic syndrome in patients with abnormal glucose metabolism. Methods: This study will enroll 880 subjects (aged 18-70 years) who have metabolic syndromes with abnormal glucose metabolism. All the participants in a double-blind, parallel, randomized, placebo-controlled trial, will receive Jinlida or placebo, orally, 9 g/time, three times daily for 2-4 years period on the basis of lifestyle intervention. The primary outcome measure (Incidence of type 2 diabetes) will be assessed during intervention cycles. Adverse events were monitored. All statistical tests will be performed using a two-sided test, and a p ≤ 0.05 (two-sided test) will be considered to be statistically significant results. Discussion: Results from this study will provide evidence on whether incorporating oral Jinlida granules treatment into lifestyle intervention can delay or inhibit the development of diabetes mellitus in metabolic syndrome subjects with abnormal glucose metabolism. Clinical trial registration: Registered at http://www.chictr.org.cn/enIndex.aspx. Trial registration number: ChiCTR1900023241.
      (Copyright © 2020 Jin, Hou, Han, Chang, Gao, Zhao, Zhao, An, Song, Piao, Lian, Xiao-lin and Jia.)
    • Comments:
      Erratum in: Front Endocrinol (Lausanne). 2020 Sep 03;11:649. (PMID: 33013713)
    • References:
      Lancet Public Health. 2019 Jul;4(7):e343-e352. (PMID: 31204284)
      Diabetes Res Clin Pract. 2005 Mar;67(3):251-7. (PMID: 15713358)
      Lancet. 2005 Sep 24-30;366(9491):1059-62. (PMID: 16182882)
      Diabetes Obes Metab. 2014 Apr;16(4):326-33. (PMID: 24118860)
      Rev Cardiovasc Med. 2007 Summer;8(3):145-53. (PMID: 17938614)
      Am J Chin Med. 2013;41(1):21-32. (PMID: 23336504)
      Diabetologia. 2005 Sep;48(9):1749-55. (PMID: 16059716)
      J Clin Endocrinol Metab. 2014 Feb;99(2):648-55. (PMID: 24432995)
      Int J Clin Exp Med. 2015 Mar 15;8(3):4620-34. (PMID: 26064395)
      J Diabetes. 2019 Jul;11(7):540-551. (PMID: 30430757)
      Lancet. 2008 May 24;371(9626):1783-9. (PMID: 18502303)
      Diabetes. 2003 May;52(5):1210-4. (PMID: 12716754)
      Zhonghua Liu Xing Bing Xue Za Zhi. 2003 Jul;24(7):551-3. (PMID: 12975005)
      J Ethnopharmacol. 2015 Feb 23;161:99-107. (PMID: 25510732)
      Diabetes Care. 2013 Jun;36(6):1687-94. (PMID: 23462666)
      N Engl J Med. 2010 Mar 25;362(12):1090-101. (PMID: 20335585)
      Lancet. 2005 Apr 16-22;365(9468):1415-28. (PMID: 15836891)
      J Ethnopharmacol. 2015 Mar 13;162:244-52. (PMID: 25577992)
    • Contributed Indexing:
      Keywords: Chinese medicine; Jinlida granules; abnormal glucose metabolism; clinical trial; metabolic syndrome
    • Molecular Sequence:
      ChiCTR ChiCTR1900023241
    • Accession Number:
      0 (Biomarkers)
      0 (Blood Glucose)
      0 (Drugs, Chinese Herbal)
      0 (jinlida)
    • Publication Date:
      Date Created: 20200717 Date Completed: 20210528 Latest Revision: 20231103
    • Publication Date:
      20240628
    • Accession Number:
      PMC7330093
    • Accession Number:
      10.3389/fendo.2020.00415
    • Accession Number:
      32670199