Journal Article

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

Supali, Taniawati, Wiria, Aprilianto E, Houwing-Duistermaat, Jeanine J, Djuardi, Yenny, Yazdanbakhsh, Maria, Tahapary, Dicky L, Sartono, Erliyani, Martin, Ivonne, Smit, Johannes W A, van Lieshout, Lisette, Guigas, Bruno, de Ruiter, Karin, Tasman, Hengki, Mayboroda, Oleg A, Soewondo, Pradana

2015

Overview

Background Insulin 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/Design To 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. Discussion The 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 registration This 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.

• Publisher: BioMed Central,BioMed Central Ltd
• Subject: Adolescent / Adult / Albendazole - administration & dosage / Albendazole - therapeutic use / Analysis / Animals / Anthelmintics - administration & dosage / Anthelmintics - therapeutic use / Blood Glucose - drug effects / Blood Glucose - metabolism / Blood sugar / Body Mass Index / Diabetes Mellitus, Type 2 - complications / Diabetes Mellitus, Type 2 - drug therapy / Diabetes Mellitus, Type 2 - immunology / Disease transmission / Double-Blind Method / Drug therapy / Female / Glucose tolerance tests / Glycosylated hemoglobin / Health aspects / Helminthiasis - complications / Helminthiasis - drug therapy / Helminthiasis - immunology / Humans / Indonesia / Infectious Diseases / Insulin / Insulin resistance / Insulin Resistance - immunology / Internal Medicine / Male / Medical Microbiology / Medical research / Medicine / Medicine & Public Health / Medicine, Experimental / Middle Aged / Parasitological diseases / Parasitology / Placebos / Risk factors / Study Protocol / Treatment Outcome / Tropical Medicine / Young Adult