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

Tahapary DL, de Ruiter K, Martin I, van Lieshout L, Guigas B, Soewondo P, Djuardi Y, Wiria AE, Mayboroda OA, Houwing-Duistermaat JJ, Tasman H, Sartono E, Yazdanbakhsh M, Smit JW, Supali T - BMC Infect. Dis. (2015)

Bottom Line: Insulin resistance is a strong predictor of the development of type 2 diabetes mellitus.Therefore the elimination of helminths might remove this beneficial effect on insulin resistance.In addition, it will give information on anthelmintic treatment efficacy and effectiveness.

View Article: PubMed Central - PubMed

Affiliation: Department of Internal Medicine, Faculty of Medicine, Universitas Indonesia, Jakarta, Indonesia. dicky.tahapary@ui.ac.id.

ABSTRACT

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.

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Related in: MedlinePlus

Flow diagram of the Sugarspin project.
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Related In: Results  -  Collection

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Fig1: Flow diagram of the Sugarspin project.

Mentions: So far, the study has provided the following data (Figure 1). At baseline, a total of 3698 individuals were registered in 752 households. Of the 2428 subjects aged 16 years or older, 1669 subjects were eligible with consent for examination. For the oral glucose tolerance test and immunological studies 339 subjects were randomly selected and gave approval.Figure 1


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

Tahapary DL, de Ruiter K, Martin I, van Lieshout L, Guigas B, Soewondo P, Djuardi Y, Wiria AE, Mayboroda OA, Houwing-Duistermaat JJ, Tasman H, Sartono E, Yazdanbakhsh M, Smit JW, Supali T - BMC Infect. Dis. (2015)

Flow diagram of the Sugarspin project.
© Copyright Policy - open-access
Related In: Results  -  Collection

License 1 - License 2
Show All Figures
getmorefigures.php?uid=PMC4389675&req=5

Fig1: Flow diagram of the Sugarspin project.
Mentions: So far, the study has provided the following data (Figure 1). At baseline, a total of 3698 individuals were registered in 752 households. Of the 2428 subjects aged 16 years or older, 1669 subjects were eligible with consent for examination. For the oral glucose tolerance test and immunological studies 339 subjects were randomly selected and gave approval.Figure 1

Bottom Line: Insulin resistance is a strong predictor of the development of type 2 diabetes mellitus.Therefore the elimination of helminths might remove this beneficial effect on insulin resistance.In addition, it will give information on anthelmintic treatment efficacy and effectiveness.

View Article: PubMed Central - PubMed

Affiliation: Department of Internal Medicine, Faculty of Medicine, Universitas Indonesia, Jakarta, Indonesia. dicky.tahapary@ui.ac.id.

ABSTRACT

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.

Show MeSH
Related in: MedlinePlus