Helminth infection and type 2 diabetes mellitus in Indonesia
| ISRCTN | ISRCTN75636394 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN75636394 |
| Secondary identifying numbers | 57-SPIN3-JRP |
- Submission date
- 24/09/2013
- Registration date
- 12/11/2013
- Last edited
- 22/01/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Infections and Infestations
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
Contact information
Scientific
Dept.of General Internal Medicine
Radboud University Nijmegen Medical Center
P.O. Box 9101
Nijmegen
6500 HB
Netherlands
| J.Smit@aig.umcn.nl |
Scientific
Dept. of Parasitology Leiden University Medical Center
Postbus 9600
Leiden
2300RC
Netherlands
| Phone | +31 (0)715 265 067 |
|---|---|
| m.yazdanbakhsh@lumc.nl |
Scientific
Dept. of Parasitology Faculty of Medicine
University of Indonesia
Salemba Raya 6
Jakarta
10430
Indonesia
| Phone | +62 (0)213 914 607 |
|---|---|
| taniawati@yahoo.com |
Study information
| 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 |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Helminth infection and type 2 diabetes mellitus in Indonesia: integrating parasitological, immunological, behavioral and metabolic studies |
| 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 |
| 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 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 1580 |
| 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 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
6500 HB
Netherlands
Sponsor information
Research organisation
Kloveniersburgwal 29
Amsterdam
1011 JV
Netherlands
| knaw@knaw.nl | |
"ROR" |
https://ror.org/043c0p156 |
Funders
Funder type
Research organisation
Private sector organisation / Universities (academic only)
- Alternative name(s)
- Royal Netherlands Academy of Arts and Sciences, KNAW
- Location
- Netherlands
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
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 |
Editorial Notes
22/01/2019: Publication references added
