TY - JOUR
T1 - Helminth infections and type 2 diabetes
T2 - A cluster-randomized placebo controlled SUGARSPIN trial in Nangapanda, Flores, Indonesia
AU - Tahapary, Dicky L.
AU - de Ruiter, Karin
AU - Martin, Ivonne
AU - van Lieshout, Lisette
AU - Guigas, Bruno
AU - Soewondo, Pradana
AU - Djuardi, Yenny
AU - Wiria, Aprilianto E.
AU - Mayboroda, Oleg A.
AU - Houwing-Duistermaat, Jeanine J.
AU - Tasman, Hengki
AU - Sartono, Erliyani
AU - Yazdanbakhsh, Maria
AU - Smit, Johannes W.A.
AU - Supali, Taniawati
N1 - Funding Information:
This study is funded by The Royal Netherlands Academy of Arts and Science (KNAW), Ref 57-SPIN3-JRP and Universitas Indonesia (Research Grant BOPTN 2742/ H2.R12/HKP.05.00/2013.). The authors thank The Indonesian Directorate General of Higher Education (DIKTI) for providing scholarship to two PhD candidates involved in this project. The authors thank Bernadus Idu as the head of sub district Nangapanda for his support, as well as to Yusuf Gedu, Husni Abdullah, Suparti as the head of village Ndeturea, Ndorurea 1 and Ndorurea respectively. Dr. Helda Sihotang and Dr Agus Tobing, as well as all health workers in Nangapanda’s Community Health Centre and Octavia as the responsible person for data entry. All local field workers, the UI team (Sudirman, Suwarto, Yosi Destani, Eka S Mulyawan, Clara C. Djimandjaja, Femmy Pical, Rospita Maylasari, Difa Stefanie, Sovia N. Linda, Budi Prasetyo) and Yvonne Kruize. Most of all, thanks to all inhabitants of Nangapanda.
Publisher Copyright:
© Tahapary et al.; licensee BioMed Central.
PY - 2015/3/18
Y1 - 2015/3/18
N2 - 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.
AB - 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.
KW - Albendazole
KW - Helminth
KW - Immunology
KW - Insulin resistance
KW - Metabolism
KW - Parasite
KW - Type 2 diabetes
UR - http://www.scopus.com/inward/record.url?scp=84926299688&partnerID=8YFLogxK
U2 - 10.1186/s12879-015-0873-4
DO - 10.1186/s12879-015-0873-4
M3 - Article
C2 - 25888525
AN - SCOPUS:84926299688
VL - 15
JO - BMC Infectious Diseases
JF - BMC Infectious Diseases
SN - 1471-2334
IS - 1
M1 - 133
ER -