Skip to main content
Key Specialties
Cardiology Diabetology Endocrinology Gastroenterology Geriatrics and Gerontology Gynecology and Obstetrics Hematology Infectious Disease Internal Medicine Nephrology Neurology Oncology Pediatrics Respiratory Medicine Rheumatology Surgery
Congress Coverage
2024 ACC Congress 2023 ESMO Congress 2023 EASD Congress 2023 ERS Congress 2023 ESC Congress 2023 EHA Congress 2023 ASCO Annual Meeting
Clinical Collections
Advances in Alzheimer’s

At a glance: The ONWARDS insulin icodec trials

A round-up of the ONWARDS phase 3 clinical trials evaluating the novel weekly insulin icodec in people with diabetes.
ADVANCED SEARCH
Log in
Top
Trials
Published in: Trials 1/2017

Open Access 01-12-2017 | Study protocol

Acupuncture paired with herbal medicine for prediabetes: study protocol for a randomized controlled trial

Authors: Xinger Li, Haiyan Liu, Huiping Feng, Zhongren Xian, Yanhong Chen, Jianping Chen, Chunzhi Tang, Xinsheng Lai, Xiaoling Lan, Huanzhen Huang, Dongdong Yu

Published in: Trials | Issue 1/2017

Login to get access

Abstract

Background

Type-2 diabetes has become a major disease and is known to seriously impair people’s health worldwide. Prediabetes includes impaired fasting glucose (IFG) and impaired glucose tolerance (IGT) and is the most critical period for preventing type-2 diabetes, as it can be identified and reversed. Studies in the past decade have indicated that acupuncture and Chinese herbal medicine may be beneficial for treating prediabetes. However, a randomized controlled trial (RCT) should be conducted to obtain more clinical evidence on this topic.

Methods/design

An RCT will be implemented in this study, using a72-week study period (24 weeks for the intervention and 48 weeks for follow-up). Participants will be recruited from the Fifth Affiliated Hospital of Guangzhou Medical University in China. Eighty participants will be randomized to the treatment group (acupuncture plus herbal medicine and health education) or the control group (health education only), 40 participants in each. People included in this study must have been diagnosed with prediabetes using Western medicine criteria. The endpoint indices include the incidence of diabetes mellitus and the reversion rate. The primary outcome is fasting plasma glucose (FPG) level, 2-h plasma glucose (2-hPG) level after a 75-g oral glucose tolerance test (OGTT), and glycosylated hemoglobin (HbA1c) level. Secondary outcomes include the following: Body Mass Index (BMI); hemorheology, including shear rates of whole-blood viscosity and plasma viscosity. Safety indices include hepatic (ALT, AST) and renal function (BUN, Cr) and records of adverse events, including diarrhoea, colds, pharyngitis, and sleep disorders. Quality control will be implemented, including quality control of the laboratory, researchers, participants, investigational drugs, data and documents, occurrence of bias, supervision, among others, according to uniform standard operating procedures (SOPs) which have been established by the Good Clinical Practice (GCP) office of the Fifth Affiliated Hospital of Guangzhou Medical University.

Discussion

The aim of this study is to evaluate the efficacy and safety of acupuncture paired with herbal medicine for the treatment of patients with prediabetes.

Trial registration

Chinese clinical trials register ChiCTR-INR-16008891. Registered on 23 July 2016.
Appendix
Available only for authorised users
Literature
1.
2.
Xu Y, Wang L, He J, et al. Prevalence and control of diabetes in Chinese adults. JAMA. 2013;310(9):948–59.CrossRefPubMed
3.
Organization WH. Global Report on Diabetes. 2016.
4.
Forouhi NG, Luan J, Hennings S, Wareham NJ. Incidence of type 2 diabetes in England and its association with baseline impaired fasting glucose: the Ely study 1990–2000. Diabet Med. 2007;24(2):200–7.CrossRefPubMed
5.
Nathan DM, Davidson MB, DeFronzo RA, et al. Impaired fasting glucose and impaired glucose tolerance: implications for care. Diabetes Care. 2007;30(3):753–9.CrossRefPubMed
6.
Knowler WC, Fowler SE, Hamman RF, et al. 10-year follow-up of diabetes incidence and weight loss in the Diabetes Prevention Program Outcomes Study. Lancet. 2009;374(9702):1677–86.CrossRefPubMed
7.
Ming-wei C, Xue-Gang Z, Xiao-hong C, Hai-yan S, Chun-lin Z, Da-tong D, Guang-bi Z, Ming-gong Y, Chang-jiang W, You-min W, Qiu Z. Clinical outcome follow-up of subjects with transient versus persistent impaired glucose tolerance. Chin J Diabetes. 2010;18(7):487–9.
8.
9.
Li G, Zhang P, Wang J, et al. The long-term effect of lifestyle interventions to prevent diabetes in the China Da Qing Diabetes Prevention Study: a 20-year follow-up study. Lancet. 2008;371(9626):1783–9.CrossRefPubMed
10.
Knowler WC, Barrett-Connor E, Fowler SE, et al. Reduction in the incidence of type 2 diabetes with lifestyle intervention or metformin. N Engl J Med. 2002;346(6):393–403.CrossRefPubMed
11.
Merlotti C, Morabito A, Pontiroli AE. Prevention of type 2 diabetes; a systematic review and meta-analysis of different intervention strategies. Diabetes Obes Metab. 2014;16(8):719–27.CrossRefPubMed
12.
13.
Tu X, Liu F, Jordan JB, et al. “Huang Qi Elixir” for proteinuria in patients with diabetic nephropathy: a study protocol for a randomized controlled pilot trial. Trials. 2013;14:223.CrossRefPubMedPubMedCentral
14.
Yan M, Wen Y, Yang L, et al. Chinese herbal medicine Tangshen Formula treatment of patients with type 2 diabetic kidney disease with macroalbuminuria: study protocol for a randomized controlled trial. Trials. 2016;17(1):259.CrossRefPubMedPubMedCentral
15.
16.
Li P, Chen Y, Liu J, et al. Efficacy and safety of tangshen formula on patients with type 2 diabetic kidney disease: a multicenter double-blinded randomized placebo-controlled trial. PLoS One. 2015;10(5):e0126027.CrossRefPubMedPubMedCentral
17.
Yang X, Zhang B, Lu X, et al. Effects of Tangshen Formula on urinary and plasma liver-type fatty acid binding protein levels in patients with type 2 diabetic kidney disease: post-hoc findings from a multi-center, randomized, double-blind, placebo-controlled trial investigating the efficacy and safety of Tangshen Formula in patients with type 2 diabetic kidney disease. BMC Complement Altern Med. 2016;16(1):246.CrossRefPubMedPubMedCentral
18.
Gao LH, Liu Q, Liu SN, et al. A refined JinQi-JiangTang tablet ameliorates prediabetes by reducing insulin resistance and improving beta cell function in mice. J Ethnopharmacol. 2014;151(1):675–85.CrossRefPubMed
19.
Wang N, Zhang D, Mao X, Zou F, Jin H, Ouyang J. Astragalus polysaccharides decreased the expression of PTP1B through relieving ER stress induced activation of ATF6 in a rat model of type 2 diabetes. Mol Cell Endocrinol. 2009;307(1–2):89–98.CrossRefPubMed
20.
Zhang K, Pugliese M, Pugliese A, Passantino A. Biological active ingredients of traditional Chinese herb Astragalus membranaceus on treatment of diabetes: a systematic review. Mini Rev Med Chem. 2015;15(4):315–29.CrossRefPubMed
21.
22.
Chan JY, Leung PC, Che CT, Fung KP. Protective effects of an herbal formulation of Radix Astragali, Radix Codonopsis and Cortex Lycii on streptozotocin-induced apoptosis in pancreatic beta-cells: an implication for its treatment of diabetes mellitus. Phytother Res. 2008;22(2):190–6.CrossRefPubMed
23.
Chan JY, Lam FC, Leung PC, Che CT, Fung KP. Antihyperglycemic and antioxidative effects of a herbal formulation of Radix Astragali, Radix Codonopsis and Cortex Lycii in a mouse model of type 2 diabetes mellitus. Phytother Res. 2009;23(5):658–65.CrossRefPubMed
24.
Ye TS, Zhang YW, Zhang XM. Protective effects of Danggui Buxue Tang on renal function, renal glomerular mesangium and heparanase expression in rats with streptozotocin-induced diabetes mellitus. Exp Ther Med. 2016;11(6):2477–83.PubMedPubMedCentral
25.
Sato M, Tai T, Nunoura Y, Yajima Y, Kawashima S, Tanaka K. Dehydrotrametenolic acid induces preadipocyte differentiation and sensitizes animal models of noninsulin-dependent diabetes mellitus to insulin. Biol Pharm Bull. 2002;25(1):81–6.CrossRefPubMed
26.
Poon TY, Ong KL, Cheung BM. Review of the effects of the traditional Chinese medicine Rehmannia Six Formula on diabetes mellitus and its complications. J Diabetes. 2011;3(3):184–200.CrossRefPubMed
27.
Hsu PC, Tsai YT, Lai JN, Wu CT, Lin SK, Huang CY. Integrating traditional Chinese medicine healthcare into diabetes care by reducing the risk of developing kidney failure among type 2 diabetic patients: a population-based case control study. J Ethnopharmacol. 2014;156:358–64.CrossRefPubMed
28.
Dai B, Wu QX, Zeng CX, et al. The effect of Liuwei Dihuang decoction on PI3K/Akt signaling pathway in liver of type 2 diabetes mellitus (T2DM) rats with insulin resistance. J Ethnopharmacol. 2016. doi:10.​1016/​j.​jep.​2016.​07.​024.
29.
Srinivasan K. Plant foods in the management of diabetes mellitus: spices as beneficial antidiabetic food adjuncts. Int J Food Sci Nutr. 2005;56(6):399–414.CrossRefPubMed
30.
Akash MS, Rehman K, Tariq M, Chen S. Zingiber officinale and type 2 diabetes mellitus: evidence from experimental studies. Crit Rev Eukaryot Gene Expr. 2015;25(2):91–112.CrossRefPubMed
31.
Islam MS, Choi H. Comparative effects of dietary ginger (Zingiber officinale) and garlic (Allium sativum) investigated in a type 2 diabetes model of rats. J Med Food. 2008;11(1):152–9.CrossRefPubMed
32.
Rani MP, Padmakumari KP, Sankarikutty B, Cherian OL, Nisha VM, Raghu KG. Inhibitory potential of ginger extracts against enzymes linked to type 2 diabetes, inflammation and induced oxidative stress. Int J Food Sci Nutr. 2011;62(2):106–10.CrossRefPubMed
33.
Li Y, Tran VH, Duke CC, Roufogalis BD. Preventive and protective properties of Zingiber officinale (Ginger) in diabetes mellitus, diabetic complications, and associated lipid and other metabolic disorders: a brief review. Evid Based Complement Alternat Med. 2012;2012:516870.PubMedPubMedCentral
34.
Goli-malekabadi N, Asgary S, Rashidi B, et al. The protective effects of Ziziphus vulgaris L. fruits on biochemical and histological abnormalities induced by diabetes in rats. J Complement Integr Med. 2014;11(3):171–7.CrossRefPubMed
35.
Zhen-yi C, Xin-sheng LAI. Analysis of principle of LAI Xin-sheng’s “Tongyuan needling technique.”. CJTCMP. 2016;31(8):2974–6.
36.
Litscher G. The application of bioengineering of acupuncture to the treatment of diabetes, insulin resistance and obesity. Diabetes Obes Metab. 2010;12(7):553–4.CrossRefPubMed
37.
Peplow PV, Baxter GD. Electroacupuncture for control of blood glucose in diabetes: literature review. J Acupunct Meridian Stud. 2012;5(1):1–10.CrossRefPubMed
38.
Lee JD, Jang MH, Kim EH, Kim CJ. Acupuncture decreases neuropeptide Y expression in the hypothalamus of rats with Streptozotocin-induced diabetes. Acupunct Electrother Res. 2004;29(1–2):73–82.CrossRefPubMed
39.
Jang MH, Shin MC, Koo GS, Lee CY, Kim EH, Kim CJ. Acupuncture decreases nitric oxide synthase expression in periaqueductal gray area of rats with streptozotocin-induced diabetes. Neurosci Lett. 2003;337(3):155–8.CrossRefPubMed
40.
Classification and diagnosis of diabetes. Diabetes Care. 2016;39 Suppl 1:S13–22.
41.
Chamberlain JJ, Rhinehart AS, Shaefer Jr CF, Neuman A. Diagnosis and management of diabetes: synopsis of the 2016 American Diabetes Association standards of medical care in diabetes. Ann Intern Med. 2016;164(8):542–52.CrossRefPubMed
Metadata
Title
Acupuncture paired with herbal medicine for prediabetes: study protocol for a randomized controlled trial
Authors
Xinger Li
Haiyan Liu
Huiping Feng
Zhongren Xian
Yanhong Chen
Jianping Chen
Chunzhi Tang
Xinsheng Lai
Xiaoling Lan
Huanzhen Huang
Dongdong Yu
Publication date
01-12-2017
Publisher
BioMed Central
Published in
Trials / Issue 1/2017
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-017-2014-4

Other articles of this Issue 1/2017

Trials 1/2017 Go to the issue

Study protocol

Perfusion by Arterial Spin labelling following Single dose Tadalafil In Small vessel disease (PASTIS): study protocol for a randomised controlled trial

Study protocol

Tropomyosin Receptor Antagonism in Cylindromatosis (TRAC), an early phase trial of a topical tropomyosin kinase inhibitor as a treatment for inherited CYLD defective skin tumours: study protocol for a randomised controlled trial

Study protocol

Pressure RElieving Support SUrfaces: a Randomised Evaluation 2 (PRESSURE 2) photographic validation sub-study: study protocol for a randomised controlled trial

Study protocol

Coping with Unusual ExperienceS for 12–18 year olds (CUES+): a transdiagnostic randomised controlled trial of the effectiveness of cognitive therapy in reducing distress associated with unusual experiences in adolescent mental health services: study protocol for a randomised controlled trial

Research

Evaluation of a bespoke training to increase uptake by midwifery teams of NICE Guidance for membrane sweeping to reduce induction of labour: a stepped wedge cluster randomised design

Research

A randomized, multi-center, prospective study comparing best medical treatment versus best medical treatment plus renal artery stenting in patients with hemodynamically relevant atherosclerotic renal artery stenosis (RADAR) – one-year results of a pre-maturely terminated study