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Hansen M, Sonne DP, Mikkelsen KH, et al. Effect of bile acid sequestrants on glycaemic control: protocol for a systematic review with meta-analysis of randomised controlled trials. BMJ Open. 2012;2(6)doi: 10.1136/bmjopen-2012-001803.
Hansen, M., Sonne, D. P., Mikkelsen, K. H., Gluud, L. L., Vilsbøll, T., & Knop, F. K. (2012). Effect of bile acid sequestrants on glycaemic control: protocol for a systematic review with meta-analysis of randomised controlled trials. BMJ open, 2(6), . https://doi.org/10.1136/bmjopen-2012-001803
Hansen, Morten, et al. "Effect of bile acid sequestrants on glycaemic control: protocol for a systematic review with meta-analysis of randomised controlled trials." BMJ open vol. 2,6 (2012). doi: https://doi.org/10.1136/bmjopen-2012-001803
Hansen M, Sonne DP, Mikkelsen KH, Gluud LL, Vilsbøll T, Knop FK. Effect of bile acid sequestrants on glycaemic control: protocol for a systematic review with meta-analysis of randomised controlled trials. BMJ Open. 2012 Nov 12;2(6). doi: 10.1136/bmjopen-2012-001803. Print 2012. PMID: 23148345; PMCID: PMC3533035.
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BMJ Open. 2012 Nov 12;2(6). doi: 10.1136/bmjopen-2012-001803. Print 2012.

Effect of bile acid sequestrants on glycaemic control: protocol for a systematic review with meta-analysis of randomised controlled trials.

BMJ open

Morten Hansen, David Peick Sonne, Kristian Hallundbæk Mikkelsen, Lise Lotte Gluud, Tina Vilsbøll, Filip Krag Knop

Affiliations

  1. Diabetes Research Division, Department of Internal Medicine, Gentofte Hospital, University of Copenhagen, Hellerup, Denmark.

PMID: 23148345 PMCID: PMC3533035 DOI: 10.1136/bmjopen-2012-001803

Abstract

INTRODUCTION: In addition to the lipid-lowering effect of bile acid sequestrants (BASs), they also lower blood glucose and, therefore, could be beneficial in the treatment of patients with type 2 diabetes mellitus (T2DM). Three oral BASs are approved by the US Food and Drug Administration (FDA) for the treatment of hypercholesterolaemia: colestipol, cholestyramine and colesevelam. The BAS colestimide/colestilan is used in Japan. Colesevelam was recently approved by the FDA for the treatment of T2DM. We plan to provide a systematic review with meta-analysis of the glucose-lowering effect of BASs with the aim to evaluate their potential as glucose-lowering agents in patients with T2DM.

METHODS AND ANALYSIS: In accordance with the preferred reporting items for systematic reviews and meta-analyses statement, a systematic review with meta-analysis of randomised clinical trials of BASs (vs placebo, oral antidiabetes drugs or insulin), reporting measures of glycaemic control in adult patients with T2DM, will be performed. Change in glycated haemoglobin constitutes the primary endpoint, and secondary endpoints include changes in fasting plasma glucose, low-density lipoprotein cholesterol, high-density lipoprotein cholesterol, total cholesterol, triglycerides, body weight and body mass index and adverse events. Electronic searches will be performed in The Cochrane Library, MEDLINE and EMBASE, along with manual searches in the reference lists of relevant papers. The analyses will be performed based on individual patient data and summarised data. The primary meta-analysis will be performed using random effects models owing to expected intertrial heterogeneity. Dichotomous data will be analysed using risk difference and continuous data using weighted mean differences, both with 95% CIs.

ETHICS AND DISSEMINATION: The study will evaluate the potential of BASs as glucose-lowering agents and possibly contribute to the clinical management of patients with T2DM.

RESULTS: The study will be disseminated by peer-review publication and conference presentation.

PROTOCOL REGISTRATION: PROSPERO CRD42012002552.

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