Parasites and risk factors for heart attack and stroke in rural and urban areas of Gabon
| ISRCTN | ISRCTN12708965 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN12708965 |
| Secondary identifying numbers | TMA2017-1956 |
- Submission date
- 21/10/2021
- Registration date
- 26/10/2021
- Last edited
- 26/10/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Plain English summary of protocol
Background and study aims
Non communicable diseases (NCDs) and Infectious diseases (IDs), such as malaria and intestinal parasites are highly prevalent in sub-Saharan Africa. Their dual burden, associated risk factors and impact are poorly studied in Central Africa.
The ParCaM study will estimate and compare the frequency of cardio-metabolic diseases risk factors (CMDRF), including metabolic syndrome, hypertension, and inflammatory biomarkers in individuals with or without intestinal parasite infection (IPIs). Differences between specific age groups, type of parasitism (protozoa, helminths) and geographical (urban versus rural) areas will be emphasized. In addition, risk groups will be identified.
Who can participate?
Volunteers
Age between 18-60 years
Residency in the city where the study will be conducted (for at least two years)
Consent form signed by the participant and the medical investigator at inclusion
What does the study involve?
A standardized World Health Organization STEPwise NCDs surveillance questionnaire will be used to obtain demographic characteristics, lifestyle, and risk factors. Blood pressure, height, weight, BMI, and waist circumference will be measured. A parasitological analysis will identify intestinal protozoa, soil-transmitted helminths including urinary and intestinal schistosomiasis. Clinical chemistry and immunological tests will allow us to identify metabolic syndrome (which involves glucose, insulin, lipids levels) and the chronic inflammation biomarkers (IL-6, TNF-, sCD14, hsCRP). The Framingham score will determine the 10-year cardiovascular risk at the beginning and the end of the follow-up. In Phase 2, selected participants will be included in an 18-month prospective cohort study to estimate the frequency of occurrence of any CMD event or risk factor.
What are the possible benefits and risks of participating?
Benefits: Cardiovascular and metabolic health status will be assessed for free, free health check up each year during three years, free treatment of parasitic diseases, cardiovascular tests done_
Risks: small pain at the venous sampling injection site, 7 ML of blood drawn 3 times in 27 months
Where is the study run from?
Universite des Sciences de la Sante (Gabon)
When is the study starting and how long is it expected to run for?
October 2019 to June 2023
Who is funding the study?
European & Developing Countries Clinical Trials Partnership
Who is the main contact?
Prof Marielle K. Bouyou Akotet, mariellebouyou@gmail.com
Contact information
Scientific
Department of Parasitology Mycology
Faculté de Médecine
Universite des Sciences de la Sante
Libreville
4009
Gabon
 ORCID ID |
0000-0002-7992-4630 |
|---|---|
| Phone | +24166303105 |
| mariellebouyou@gmail.com |
Study information
| Study design | Obervational cohort study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cohort study |
| Study setting(s) | Community |
| Study type | Diagnostic |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet. |
| Scientific title | Contribution of intestinal parasite infections in the risk of developing cardio-metabolic diseases in rural and urban areas of Gabon: a pilot study. |
| Study acronym | ParCam |
| Study objectives | Inflammatory response and dysbiosis due to intestinal parasite infection (IPI) lead to dyslipidemia, type 2 diabetes and their cardiovascular (CVD) consequences. This will be translated into higher frequency of these CMD risk factors (CMDRF) in participants chronically or repeatedly infected when compared to uninfected participants. As exposition to IPI and type of parasitism are different between urban and rural areas, biomarkers of CMDRF will show different patterns according to the urbanisation. Precisely, we hypothesise that there will be more metabolic syndrome, more inflammation (as measured by IL-6, TNF-α, hsCRP) and more monocyte activation (as measured by sCD14) in chronically or repeatedly parasite-infected than in uninfected participants with difference according to urbanisation. |
| Ethics approval(s) | Approved 10/02/2021, Comite National d'ethique pour la Recherche (Bp 2217 Libreville - Gabon; +241 66815320; no email provided), ref: PROT N'002/2020/PR/SG/CNE |
| Health condition(s) or problem(s) studied | Risk of cardiometabolic diseases in patients with chronic parasitism |
| Intervention | During Phase I, the population and the chief from the districts of Libreville and Koulamoutou from two provinces in Gabon, will be informed about the aim, the importance and the benefit of the study. In addition, the study team will be trained on biological sample collection, testing and storage and the questionnaire related to this study will be tested. Phase I will be carried out over a period of 12 months. Data management standard operating procedures (SOPs) and methodology will be set up. The second phase will be the cross-sectional survey, which corresponds to the screening for physical and biological risk factors over a 12-15 month period. After eligibility criteria verification and informed consent, interview, clinical examination and blood collection for biochemical tests and further biomarkers measurements will be performed at day 0. On day 1, urine and stools samples will be collected for parasitological tests and for aliquots of consenting participants for further sub-studies and will be stored in a -80°C freezer as well as dried blood spots. The third phase will be the 27month prospective cohort study comparing the frequency of the occurrence of CMDRF or events including hypertension among the parasite-infected and uninfected participants of urban and rural areas. This phase will include three control visits: visit 1 (12-15 months after inclusion), visit 2 (24-27 months after inclusion), and visit 3 (36-39 months after inclusion). For all these visits, a delay of ± 1 month will be allowed. During each visit, a record of medical history and treatment, a complete clinical examination with blood pressure, determination of blood glucose, HbA1c, and lipids parameters as well as a sample for biomarker measurement and the Framingham score risk will be determined. The parasitological stool analysis will be performed during visits 2 and 3. At the last visit, the complete procedure as performed in phase 2, as well as the complete biomarkers measurement to determine the occurrence of CMD including hypertension or the modification of CMDRF will be realised. |
| Intervention type | Other |
| Primary outcome measure | Frequency or incidence of CMD risk factors (defined as the presence of any of the following conditions: metabolic syndrome, high level of inflammatory and monocyte activation markers, High Framingham score) in parasitic-infected and non-infected individuals in urban versus rural areas (from patient records at months 36-39) |
| Secondary outcome measures | Measured using patient records: 1. Incidence of IPIs in urban and rural areas (months 24 – 27, and months 36-39) 2. Prevalence of new CMDRF in urban and rural areas at the end of the cohort study (months 36-39) 3. Evolution of Framingham score globally and according to the type of parasitism and study area (months 12-15; months 24-27, and months 36-39) 4. Evolution of the levels of inflammatory biomarkers in participants from urban and rural areas (months 12-15; months 24-27, and months 36-39) 5. Incidence of CMDRF, including metabolic syndrome, chronic inflammation, and high blood pressure in the general population and between groups. (months 36-39) |
| Overall study start date | 01/10/2019 |
| Completion date | 30/06/2023 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 60 Years |
| Sex | Both |
| Target number of participants | 408 |
| Key inclusion criteria | 1. Age between 18-60 years 2. Residency in the city where the study will be conducted (since at least two years) 3. Consent form signed by the participant and the medical investigator at inclusion |
| Key exclusion criteria | 1. Patients <18 years and >60years 2. Severe clinical event under investigation, that is life-threatening, uncontrolled 3. Refusal to participate in the study 4. Patient who should travel a long distance to the study site 5. History of coronary disease or stroke 6. Active/chronic viral hepatitis 7. HIV infection 8. Tuberculosis known patients 9. Fever or antimalarial drug intake within the last 2 months 10. Other antiparasitic treatment within the 6 months preceding the recruitment |
| Date of first enrolment | 23/09/2020 |
| Date of final enrolment | 31/01/2023 |
Locations
Countries of recruitment
- Gabon
Study participating centre
Libreville
4009
Gabon
Sponsor information
Charity
Anna van Saksenlaan 51 2593 HW
The Hague
2593
Netherlands
| Phone | +31 70 344 0880 |
|---|---|
| edctpgrants@edctp.org | |
| Website | http://www.edctp.org/ |
"ROR" |
https://ror.org/031jv9v19 |
Funders
Funder type
Government
No information available
Results and Publications
| Intention to publish date | 30/03/2024 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | The fellow will work through the National Control Programmes to undertake every possible effort to ensure that results and products from the project are made available to the communities. Community feedback will be incorporated into our quarterly reports. Dissemination of project data to the community, civil society groups, NGOs, donors and funders will be made through regular email contact and sharing of outputs. For the local and international scientific committee, the dissemination of scientific knowledge will be made available through publications in peer reviewed journals (at least 3 in open access), oral communications or poster presentations during scientific conferences (e.g. EDCTP Forum, ASTMH meeting, French Hearth Diseases annual congress, African Society of Parasitology congress in 2020 and 2022, African Society of Cardiology; French Society of Parasitology), meetings etc.: The first publication will report, at the end of the cross-sectional survey “the sociodemographics and lifestyle risk factors for NCDs and IPIs in urban versus rural cities of Gabon . The other publications will present the following aspects: - Prevalence of IPIs mong urban and rural inhabitants of settlements of Gabon - Biomarkers of CMDR in inhabitants of two countries from west and central Africa - Incidence of IPIs and relationship with biomarkers of CMDRF in rural versus urban settlements of Gabon - Prevalence of cardiovascular abnormalities before and after 24 months of antiparasitic treatment in patients with chronic parasitism. |
| IPD sharing plan | Statement will be made available later |
Editorial Notes
26/10/2021: Trial's existence confirmed by Comite National d'ethique pour la Recherche, Gabon
