Plain English Summary
Background and study aims
The co-occurrence of infectious diseases and non-communicable diseases (not caused by infection) is poorly studied, despite the fact that this dual burden has become a reality for many low- and middle-income countries (LMICs). Even very little is known about how common infectious diseases (e.g. worms and malaria) and non-communicable diseases (e.g. high blood pressure and diabetes) influence each other. Repeated and chronic (long-term) infections that are common in LMICs may alter people’s susceptibility to diabetes and heart disease. Worm infections may shift the immune system into a direction protecting against inflammatory diseases, whereas repeated infections such as malaria may increase the risk of inflammatory diseases. Adults surviving often lethal infections in LMICs may have a genetically different susceptibility to age-related diseases (e.g. high blood pressue). As a result, people in LMICs may develop these diseases at different rates and at different ages than Western populations. If confirmed, this calls for changes in the provision of health services. The aim of this study is to carry out a survey of adults from rural and urban parts of the Taabo district in south-central Côte d’Ivoire to study the co-occurrence of worm infections and malaria with metabolic syndrome, high blood pressure and diabetes.
Who can participate?
Adults (aged at least 18) from three selected villages
What does the study involve?
The survey consists of health examinations to assess the incidence of high blood pressure, diabetes, worm and malaria infections, lifestyle and risks of infectious and non-communicable diseases. Confirmatory tests are provided as well as a free first month of treatment and enrolment into subsidized national care programmes. A biobank of collected biospecimens (e.g. stool and urine samples) is set up for future research.
What are the possible benefits and risks of participating?
All participants benefit from health examinations, laboratory tests, physician consultation and treatment, all free of charge. Participants receive health advice from the physician regardless of disease status. Participating health centres are equipped with diagnostic tools, and participating health workers are trained in non-communicable disease diagnosis and management. The biobank will improve local research. There are no specific risks associated with this study, although providing stool and urine samples might be perceived as shameful. Furthermore, common drugs used for the treatment of worms, malaria, diabetes and high blood pressure might result in some side effects, but these are usually few, short-lived and the benefits outweigh the risk of not being treated.
Where is the study run from?
The study is conducted in three rural communities located in the Taabo district in south-central Côte d'Ivoire
When is the study starting and how long is it expected to run for?
April 2017 to December 2017
Who is funding the study?
Novartis Foundation (Switzerland)
Who is the main contact?
Prof. Nicole Probst-Hensch
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Co-occurrence of common chronic infections (soil-transmitted helminths and Plasmodium) and common non-communicable diseases (diabetes and hypertension) in rural and urban Côte d’Ivoire
Acronym
CoDuBu
Study hypothesis
Repeated and chronic infections that are common in low- and middle-income countries (LMICs) may alter the susceptibility to diabetes and cardiovascular diseases as well as their related phenotypes, albeit in an infection-specific manner. Adults surviving often lethal infections in the context of LMICs may have a genetically different susceptibility to diabetes and hypertension.
Ethics approval
1. Ethikkommission beider Basel (EKBB, Switzerland), 25/07/2011, ref: 2016-00143
2. Comité National d’Ethique et de la Recherche (CNER, Côte d’Ivoire), 24/03/2017, ref: 032/IMSHP/CNER-kp
Study design
Observational cross-sectional survey
Primary study design
Observational
Secondary study design
Cross sectional study
Trial setting
Community
Trial type
Prevention
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet
Condition
Non-communicable diseases, infectious diseases
Intervention
The study involves a baseline cross-sectional survey which will be carried out in three selected villages in the Taabo HDSS, followed by the establishment of a biobank. The cross-sectional survey consists of health examination to determine anthropometric indices, metabolic syndrome, as well as helminthic and malaria infections. It will also include questionnaire survey with regard to lifestyle and risks of IDs and NCDs. Identified cases of ID and NCD will be managed accordingly. Confirmatory tests will be provided for NCD cases as well as free first month of treatment and enrolment into subsidized national care programmes. A biobank consisting of collected biospecimens will be set-up for future research into mechanisms incolved in ID-NCD interactions.
Intervention type
Phase
Drug names
Primary outcome measure
All outcomes measured at baseline:
1. Hypertension, assessed using blood pressure monitor and questionnaire
2. Diabetes, assessed using blood glucose and glycosylated hemoglobin tests and questionnaire
3. Helminth infection, assessed using Kato-Katz stool test, Baermann stool test, medical test
4. Malaria, assessed using rapid diagnostic blood test and microscopy
Secondary outcome measures
No secondary outcome measures
Overall trial start date
23/04/2017
Overall trial end date
31/12/2017
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Age >= 18 years
2. Residence in the selected communities
3. Written informed consent to participate
Participant type
All
Age group
Adult
Gender
Both
Target number of participants
1000
Participant exclusion criteria
1. Residence in the selected communities
2. No written informed consent to participate
Recruitment start date
23/04/2017
Recruitment end date
31/05/2017
Locations
Countries of recruitment
Cote d'Ivoire
Trial participating centre
Swiss Tropical and Public Health Institute
Socinstrasse 57
Basel
4051
Switzerland
Trial participating centre
Centre Suisse de Recherches Scientifiques en Côte d'Ivoire
01
Abidjan
01 BP 1303
Cote d'Ivoire
Trial participating centre
Université Félix Houphouët-Boigny
22
Abidjan
BP1106
Trial participating centre
Institut National de Sante Publique
Abidjan
BP V 47
Cote d'Ivoire
Trial participating centre
Ligue Ivoirienne contre l’Hypertension artérielle et les Maladies Cardiovasculaires
01
Abidjan
BP 2858
Cote d'Ivoire
Trial participating centre
Institut Pasteur de Côte d'Ivoire
01
Abidjan
BP 490
Cote d'Ivoire
Sponsor information
Organisation
Swiss Tropical and Public Health Institute
Sponsor details
Socinstrasse 57
Basel
4051
Switzerland
Sponsor type
Research organisation
Website
Funders
Funder type
Other
Funder name
Novartis Foundation
Alternative name(s)
Funding Body Type
private sector organisation
Funding Body Subtype
international
Location
Switzerland
Results and Publications
Publication and dissemination plan
Planned publication of study protocol and the study results in the peer-reviewed (whenever possible open-access) literature before the end of 2019.
IPD sharing statement
The data sharing plans for the current study are unknown and will be made available at a later date.
Intention to publish date
31/12/2019
Participant level data
To be made available at a later date
Basic results (scientific)
Publication list
2017 results in https://www.ncbi.nlm.nih.gov/pubmed/29079553