Plain English Summary
Background and study aims
Helminth infections induce strong immune responses that decrease inflammation, allowing their long-term survival in the human body. These infections may decrease chronic inflammation and associated diseases, including type 2 diabetes. Asia is the major site of a rapidly emerging epidemic of diabetes. In addition to the disappearance of traditional diets, adaptation to urban conditions and related disturbances in energy balance, we propose that decreasing helminth infections in rural and urban areas may be contributing to the increase in type 2 diabetes. We want to look at the effect of drug treatment of soil-transmitted helminth infections on insulin resistance and metabolic/immunologic related factors.
Who can participate?
Men and women over 16 years of age living in the Nangapanda area, Flores Island, Indonesia can participate in the study.
What does the study involve?
Participating households are randomly allocated to receive albendazole or placebo (dummy) to be taken orally for 3 consecutive days, every 3 months for one year.
What are the possible benefits and risks of participating?
Participating households are expected to benefit from free diagnosis and treatment of soil-transmitted helminths. The treatment can have some side effects which include nausea, vomiting and other digestive symptoms, but the study team will provide treatment for these side effects.
Where is the study run from?
The study is conducted in the households of the Nangapanda area, Flores Island, Indonesia.
When is the study starting and how long is it expected to run for?
The study will start in April 2014 and is expected to run for a year and a half.
Who is funding the study?
Royal Netherlands Academy of Arts and Sciences (KNAW).
Who is the main contact?
Professor Johannes W.A. Smit, MD PhD
J.Smit@aig.umcn.nl
Study website
Contact information
Type
Scientific
Contact name
Prof Johannes W.A. Smit
ORCID ID
Contact details
Dept.of General Internal Medicine
Radboud University Nijmegen Medical Center
P.O. Box 9101
Nijmegen
6500 HB
Netherlands
-
J.Smit@aig.umcn.nl
Type
Scientific
Contact name
Prof Maria Yazdanbakhsh
ORCID ID
Contact details
Dept. of Parasitology Leiden University Medical Center
Postbus 9600
Leiden
2300RC
Netherlands
+31 (0)715 265 067
m.yazdanbakhsh@lumc.nl
Type
Scientific
Contact name
Dr Taniawati Supali
ORCID ID
Contact details
Dept. of Parasitology Faculty of Medicine
University of Indonesia
Salemba Raya 6
Jakarta
10430
Indonesia
+62 (0)213 914 607
taniawati@yahoo.com
Additional identifiers
EudraCT/CTIS number
IRAS number
ClinicalTrials.gov number
Protocol/serial number
57-SPIN3-JRP
Study information
Scientific title
Helminth infection and type 2 diabetes mellitus in Indonesia: integrating parasitological, immunological, behavioral and metabolic studies
Acronym
Study hypothesis
Soil-transmitted helminth infections suppress insulin resistance and this suppression is reversible by antihelminthic treatment.
Ethics approval(s)
Health Research Ethics Committee, Faculty of Medicine, Universitas Indonesia Cipto Mangun Kusumo Hospital, Jakarta, Indonesia, 09/09/2013, reference number:549/H2.F1/ETIK/2013
Study design
Household-based randomised double-blind placebo-controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Study setting(s)
Other
Study type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Soil-transmitted helminth infection
Intervention
Households are randomized to two groups:
1. 400 mg albendazole
2. Placebo
Given orally for 3 consecutive days, every 3 months. Patients are followed up for one year.
Intervention type
Drug
Pharmaceutical study type(s)
Phase
Not Applicable
Drug/device/biological/vaccine name(s)
Albendazole
Primary outcome measure
Changes in insulin resistance as assessed by HOMA-IR (Homeostatic Model of Assessment-Insulin Resistance), one year post treatment
Secondary outcome measures
Energy metabolism and immunological parameters related to energy metabolism, measured one year post treatment.
1. Changes in body mass index and waist circumference measured by SECA tools
2. Changes in serum fasting blood glucose and HBA1c using a glucose meter
3. Changes in serum lipid levels, measured by commercial enzymatic kits
4. Changes in helminth load, measured by polymerase chain reaction (PCR)
5. Changes in immune polarization: FACS, intracellular staining, enzyme-linked immunosorbent assay (ELISA)
Overall study start date
01/04/2014
Overall study end date
01/10/2015
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Those who have given informed consent
2. Both males and females
3. Aged 16 years or older
4. Live in Nangapanda area, Flores Island
5. Good health, without any serious clinical condition
Participant type(s)
Patient
Age group
Adult
Sex
Both
Target number of participants
1580
Participant exclusion criteria
1. Subjects younger than 16 years
2. Active treatment for diabetes mellitus
3. Serious concomitant disease
4. Pregnant women
5. No informed consent
Recruitment start date
01/04/2014
Recruitment end date
01/10/2015
Locations
Countries of recruitment
Indonesia, Netherlands
Study participating centre
Radboud University Nijmegen Medical Center
Nijmegen
6500 HB
Netherlands
Sponsor information
Organisation
The Royal Netherlands Academy of Arts and Sciences (Netherlands)
Sponsor details
Kloveniersburgwal 29
Amsterdam
1011 JV
Netherlands
-
knaw@knaw.nl
Sponsor type
Research organisation
Website
ROR
Funders
Funder type
Research organisation
Funder name
Koninklijke Nederlandse Akademie van Wetenschappen
Alternative name(s)
Royal Netherlands Academy of Arts and Sciences, KNAW
Funding Body Type
private sector organisation
Funding Body Subtype
Universities (academic only)
Location
Netherlands
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Individual participant data (IPD) sharing plan
IPD sharing plan summary
Not provided at time of registration
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 18/03/2015 | Yes | No | |
| Results article | results | 17/11/2018 | 22/01/2019 | Yes | No |
| Results article | results | 18/03/2015 | 22/01/2019 | Yes | No |
| Results article | results of the effect of anthelmintic treatment on insulin resistance. | 01/09/2017 | 22/01/2019 | Yes | No |
| Results article | results of the effect of anthelmintic treatment on leptin, adiponectin and leptin to adiponectin ratio. | 16/10/2017 | 22/01/2019 | Yes | No |