MalariaNCT06278181
Diabetes, Metabolic Syndrome and Risk of Malaria in Cameroon
An observational study of Malaria and Diabetes Mellitus, run by Karolinska Institutet at 1 site in Cameroon.
Trial summary
Non-communicable diseases (NCDs) such as diabetes are increasing in countries where malaria transmission is common. This study aims to investigate the relationship between NCDs and parasitic infections in Cameroon. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Malaria, Diabetes Mellitus, Metabolic Syndrome
- How many people
- 406 participants
- Where
- 1 siteCameroon
- Study dates
- 21 Sep 2023to 19 Mar 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adult patients with type 2 diabetes identified at the outpatient diabetes clinic of Limbe Regional Hospital will be invited to the study. Community comparators matched on age and sex will be identified in the patients' family or in the home community to control for exposure to similar malaria transmission.
Who may be able to join
None listed.
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Risk of Malaria and Other Parasitic Infections in Individuals With Type 2 Diabetes With or Without Metabolic Syndrome in Cameroon.
Non-communicable diseases (NCDs) such as diabetes are increasing in countries where malaria transmission is common. This study aims to investigate the relationship between NCDs and parasitic infections in Cameroon. The investigators will assess the risk of malaria, as well as other parasitic diseases, in a prospectively followed group of adults with diabetes, compared with those without diabetes. Malaria parasites and intestinal worms will be tested using blood and stool collected at four time points during a one-year follow-up. In addition, this project will investigate how natural protection against malaria is affected by diabetes and other risk factors for heart diseases.
Read the detailed description
Studies have suggested that diabetes could be associated with both increased risk of and protection from infection with certain protozoans and helminths. A study from Ghana demonstrated an increased risk of asymptomatic malaria in individuals with type 2 diabetes, compared to healthy subjects. On the contrary, a Chinese study found a lower prevalence of diabetes and metabolic syndrome among adults previously exposed to Schistosoma. In sub-Saharan Africa, endemic to these parasitic infections, limited is known on their interaction with diabetes and metabolic syndrome. Findings from this study can inform policy to better integrate public health measures to improve the care of individuals with chronic non-communicable diseases such as diabetes and metabolic syndrome living at risk of malaria and other parasitic infections and prevent them from complications.
This study aims to investigate whether diabetes with/without metabolic syndrome affects the risk of malaria and antibody-mediated immunity to malaria in adults, and if this risk is specific to malaria or also observed in other parasitic infections.
This will be a prospective cohort study conducted at the Limbe Regional Hospital and Global Health Systems Laboratory in the Southwest Region of Cameroon. This cohort will comprise two groups of participants: the exposed group comprised of patients with type 2 diabetes (T2DM), and an unexposed group made of individuals without diabetes. Participants will be aged 21 years and above and must provide written informed consent to be part of the cohort. For every patient with diabetes included in the study, a participant without diabetes matched for sex and age (±5 years) and living in the same neighborhood will be identified and involved in the study. All participants will be assessed at the beginning, and every third months after the initiation into the cohort, and up to 4 times in 1 year. During each study encounter, participants will be tested for malaria through microscopy rapid diagnostic testing (RDT), and PCR to detect low-level parasitemia and confirm the plasmodium species. Also, stool analysis and urine microscopy will be performed, together with serological markers to enable the detection of helminths. At each visit, a full blood count, lipid profile, fasting plasma glucose, hemoglobin electrophoresis, creatinine for kidney function, HIV, and glycated hemoglobin tests will be done. The blood pressure, weight and height, and waist circumference will be measured at each encounter to aid in determining metabolic syndrome. Stored plasma samples will be analyzed on a panel of antigens using ELISA and a Luminex assay to measure the antibody response to malaria.
Data will be analyzed using STATA. Descriptive statistics will be performed to determine the incidence of parasites using the Kaplan-Meyer method, and between-group comparisons of proportions done using the Chi-Squared tests or Fisher´s exact tests, and continuous data using the t-test. The risk of asymptomatic parasitemia in the exposed and the unexposed groups will be estimated using Cox proportional hazards regression. Age, sex, BMI, and additional patient characteristics such as socioeconomic factors, HIV status, and hemoglobinopathies will be included in a multivariable model to adjust for confounding. Stratified analyses and interaction terms will be used to evaluate if metabolic syndrome modifies the risk. Age and sex-stratified analysis will also be performed.
- Conditions
- Malaria, Diabetes Mellitus, Metabolic Syndrome, Endemic
- Medical subject headings
- Malaria, Diabetes Mellitus, Metabolic Syndrome, Burkitt Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Type 2 diabetes | Individuals with type 2 diabetes followed by the diabetes clinic at Limbe hospital | |
| Diabetes free | Community controls without diabetes, referred by the patients with diabetes. The unexposed individuals referred should have approximately the same age, be of same sex and health cathment area as the exposed individual |
What is being measured
The primary outcome is the main question the study is designed to answer.
asymptomatic malaria
malaria parasites detected by RDT/microscopy/PCR
Measured: 1 year follow up
Secondary outcomes (1)
symptomatic malaria
any symptomatic malaria detected during the study period , defined as symptoms such as fever, headache, body ache and positive microscopy and/or RDT
Measured: 1 year follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2024
- Study start21 Sep 2023
- Primary completion19 Mar 2025
- Study completion19 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MalariaStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 406 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Collaborators
- University of Dschang, European Foundation for the Study of Diabetes
- Responsible party
- Principal investigator, George Awungafac, Karolinska Institutet
- Investigators
- Katja Wyss, PhD MD, Principal investigator, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06278181
- Sponsor's protocol ID
- 2023/08/1545
- Status last verified
- Aug 2025
- First submitted
- 19 Feb 2024
- Last updated
- 3 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk of Malaria and Other Parasitic Infections in Individuals With Type 2 Diabetes With or Without Metabolic Syndrome in Cameroon.
- ClinicalTrials.gov ID
- NCT06278181
- Acronym / sponsor ID
- 2023/08/1545
- Conditions
- Malaria, Diabetes Mellitus, Metabolic Syndrome, Endemic
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 406 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Collaborators
- University of Dschang, European Foundation for the Study of Diabetes
- Study start
- 21 Sep 2023 (actual)
- Primary completion
- 19 Mar 2025 (actual)
- Study completion
- 19 Mar 2025 (actual)
- First posted
- 26 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Non-communicable diseases (NCDs) such as diabetes are increasing in countries where malaria transmission is common. This study aims to investigate the relationship between NCDs and parasitic infections in Cameroon. The investigators will assess the risk of malaria, as well as other parasitic diseases, in a prospectively followed group of adults with diabetes, compared with those without diabetes. Malaria parasites and intestinal worms will be tested using blood and stool collected at four time points during a one-year follow-up. In addition, this project will investigate how natural protection against malaria is affected by diabetes and other risk factors for heart diseases.
Detailed description
Studies have suggested that diabetes could be associated with both increased risk of and protection from infection with certain protozoans and helminths. A study from Ghana demonstrated an increased risk of asymptomatic malaria in individuals with type 2 diabetes, compared to healthy subjects. On the contrary, a Chinese study found a lower prevalence of diabetes and metabolic syndrome among adults previously exposed to Schistosoma. In sub-Saharan Africa, endemic to these parasitic infections, limited is known on their interaction with diabetes and metabolic syndrome. Findings from this study can inform policy to better integrate public health measures to improve the care of individuals with chronic non-communicable diseases such as diabetes and metabolic syndrome living at risk of malaria and other parasitic infections and prevent them from complications.
This study aims to investigate whether diabetes with/without metabolic syndrome affects the risk of malaria and antibody-mediated immunity to malaria in adults, and if this risk is specific to malaria or also observed in other parasitic infections.
This will be a prospective cohort study conducted at the Limbe Regional Hospital and Global Health Systems Laboratory in the Southwest Region of Cameroon. This cohort will comprise two groups of participants: the exposed group comprised of patients with type 2 diabetes (T2DM), and an unexposed group made of individuals without diabetes. Participants will be aged 21 years and above and must provide written informed consent to be part of the cohort. For every patient with diabetes included in the study, a participant without diabetes matched for sex and age (±5 years) and living in the same neighborhood will be identified and involved in the study. All participants will be assessed at the beginning, and every third months after the initiation into the cohort, and up to 4 times in 1 year. During each study encounter, participants will be tested for malaria through microscopy rapid diagnostic testing (RDT), and PCR to detect low-level parasitemia and confirm the plasmodium species. Also, stool analysis and urine microscopy will be performed, together with serological markers to enable the detection of helminths. At each visit, a full blood count, lipid profile, fasting plasma glucose, hemoglobin electrophoresis, creatinine for kidney function, HIV, and glycated hemoglobin tests will be done. The blood pressure, weight and height, and waist circumference will be measured at each encounter to aid in determining metabolic syndrome. Stored plasma samples will be analyzed on a panel of antigens using ELISA and a Luminex assay to measure the antibody response to malaria.
Data will be analyzed using STATA. Descriptive statistics will be performed to determine the incidence of parasites using the Kaplan-Meyer method, and between-group comparisons of proportions done using the Chi-Squared tests or Fisher´s exact tests, and continuous data using the t-test. The risk of asymptomatic parasitemia in the exposed and the unexposed groups will be estimated using Cox proportional hazards regression. Age, sex, BMI, and additional patient characteristics such as socioeconomic factors, HIV status, and hemoglobinopathies will be included in a multivariable model to adjust for confounding. Stratified analyses and interaction terms will be used to evaluate if metabolic syndrome modifies the risk. Age and sex-stratified analysis will also be performed.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Type 2 diabetes | – | –Individuals with type 2 diabetes followed by the diabetes clinic at Limbe hospital |
| Diabetes free | – | –Community controls without diabetes, referred by the patients with diabetes. The unexposed individuals referred should have approximately the same age, be of same sex and health cathment area as the exposed individual |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients with type 2 diabetes identified at the outpatient diabetes clinic of Limbe Regional Hospital will be invited to the study. Community comparators matched on age and sex will be identified in the patients' family or in the home community to control for exposure to similar malaria transmission.
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
asymptomatic malaria
Time frame: 1 year follow up
malaria parasites detected by RDT/microscopy/PCR
1 secondary outcome
symptomatic malaria
Time frame: 1 year follow up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Katja Wyss, PhD MD principal investigator
Karolinska Institutet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Malaria and Diabetes Mellitus, run by Karolinska Institutet at 1 site in Cameroon.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Cameroon. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
asymptomatic malaria (time frame: 1 year follow up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2025.