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

Frontiers in Endocrinology
De JinZhenhua Jia

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...Continue Reading

References

Apr 30, 2003·Diabetes·Charles M AlexanderUNKNOWN National Cholesterol Education Program (NCEP)
Feb 17, 2005·Diabetes Research and Clinical Practice·G Neil ThomasUNKNOWN Hong Kong Cardiovascular Risk Factor Prevalence Study Steering Committee
Apr 20, 2005·Lancet·Robert H EckelPaul Z Zimmet
Sep 27, 2005·Lancet·K George M M AlbertiUNKNOWN IDF Epidemiology Task Force Consensus Group
Mar 26, 2010·The New England Journal of Medicine·Wenying YangUNKNOWN China National Diabetes and Metabolic Disorders Study Group
Jan 23, 2013·The American Journal of Chinese Medicine·Yanbin GaoMingzheng Pan
Jan 13, 2015·Journal of Ethnopharmacology·Yixuan LiuLiyuan Duan

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Software Mentioned

PASS16
Jinlida
SAS®

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