Helminth infections and type 2 diabetes: a cluster-randomized placebo controlled SUGARSPIN trial in Nangapanda, Flores, Indonesia

BMC Infectious Diseases

Study Protocol

Oleg A Mayboroda¹  Pradana Soewondo²  Dicky L Tahapary³  Johannes W A Smit⁴  Hengki Tasman⁵  Jeanine J Houwing-Duistermaat⁶  Ivonne Martin⁷  Aprilianto E Wiria⁸  Taniawati Supali⁸  Yenny Djuardi⁸  Maria Yazdanbakhsh⁹  Karin de Ruiter⁹  Erliyani Sartono⁹  Lisette van Lieshout⁹  Bruno Guigas^1,10 

[1] Center for Proteomics and Metabolomics, Leiden University Medical Center, Leiden, The Netherlands;Department of Internal Medicine, Faculty of Medicine, Universitas Indonesia, Jakarta, Indonesia;Department of Internal Medicine, Faculty of Medicine, Universitas Indonesia, Jakarta, Indonesia;Department of Parasitology, Leiden University Medical Center, Leiden, The Netherlands;Department of Internal Medicine, Radboud University Medical Centre, Nijmegen, The Netherlands;Department of Internal Medicine, Leiden University Medical Center, Leiden, The Netherlands;Department of Mathematics, Faculty of Mathematics and Natural Science, Universitas Indonesia, Jakarta, Indonesia;Department of Medical Statistics and Bioinformatics, Leiden University Medical Center, Leiden, The Netherlands;Department of Medical Statistics and Bioinformatics, Leiden University Medical Center, Leiden, The Netherlands;Department of Mathematics, Parahyangan Catholic University, Bandung, Indonesia;Department of Parasitology, Faculty of Medicine, Universitas Indonesia, Jakarta, Indonesia;Department of Parasitology, Leiden University Medical Center, Leiden, The Netherlands;Department of Parasitology, Leiden University Medical Center, Leiden, The Netherlands;Department of Molecular Cell Biology, Leiden University Medical Center, Leiden, The Netherlands;

关键词: Insulin resistance;    Helminth;    Type 2 diabetes;    Parasite;    Metabolism;    Albendazole;    Immunology;   

DOI  :  10.1186/s12879-015-0873-4

 received in 2015-02-24, accepted in 2015-03-09,  发布年份 2015

来源: Springer

【 摘 要 】

BackgroundInsulin resistance is a strong predictor of the development of type 2 diabetes mellitus. Chronic helminth infections might protect against insulin resistance via a caloric restriction state and indirectly via T-helper-2 polarization of the immune system. Therefore the elimination of helminths might remove this beneficial effect on insulin resistance.Methods/DesignTo determine whether soil-transmitted helminth infections are associated with a better whole-body insulin sensitivity and whether this protection is reversible by anthelmintic treatment, a household-based cluster-randomized, double blind, placebo-controlled trial was conducted in the area of Nangapanda on Flores Island, Indonesia, an area endemic for soil-transmitted helminth infections. The trial incorporates three monthly treatment with albendazole or matching placebo for one year, whereby each treatment round consists of three consecutive days of supervised drug intake. The presence of soil-transmitted helminths will be evaluated in faeces using microscopy and/or PCR. The primary outcome of the study will be changes in insulin resistance as assessed by HOMA-IR, while the secondary outcomes will be changes in body mass index, waist circumference, fasting blood glucose, 2 h-glucose levels after oral glucose tolerance test, HbA1c, serum lipid levels, immunological parameters, and efficacy of anthelmintic treatment.DiscussionThe study will provide data on the effect of helminth infections on insulin resistance. It will assess the relationship between helminth infection status and immune responses as well as metabolic parameters, allowing the establishment of a link between inflammation and whole-body metabolic homeostasis. In addition, it will give information on anthelmintic treatment efficacy and effectiveness.Trial registrationThis study has been approved by the ethical committee of Faculty of Medicine Universitas Indonesia (ref: 549/H2.F1/ETIK/2013), and has been filed by the ethics committee of Leiden University Medical Center, clinical trial number: ISRCTN75636394. The study is reported in accordance with the CONSORT guidelines for cluster-randomised trials.

【 授权许可】

Unknown   
© Tahapary et al.; licensee BioMed Central. 2015. This article is published under license to BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/4.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly credited. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.