Condition category
Not Applicable
Date applied
26/07/2017
Date assigned
27/07/2017
Last edited
27/07/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

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

Contact information

Type

Scientific

Primary contact

Prof Nicole Probst-Hensch

ORCID ID

Contact details

Socinstrasse 57
Basel
4051
Switzerland

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 measures

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

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

http://www.swisstph.ch

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes