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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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.

Cameroon1 site
  • Limbe Regional Hospital

    Limbe

Other trials in Cameroon

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.

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 groups in NCT06278181
Study groupRoleWhat they receive
Type 2 diabetesIndividuals with type 2 diabetes followed by the diabetes clinic at Limbe hospital
Diabetes freeCommunity 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.

  1. asymptomatic malaria

    malaria parasites detected by RDT/microscopy/PCR

    Measured: 1 year follow up

Secondary outcomes (1)
  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.

  1. First posted26 Feb 2024
  2. Study start21 Sep 2023
  3. Primary completion19 Mar 2025
  4. Study completion19 Mar 2025

Resources

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)
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

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.

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