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CompletedNCT06278181Updated Sep 3, 2025

Diabetes, Metabolic Syndrome and Risk of Malaria in Cameroon

An observational study in Malaria, Diabetes Mellitus and Metabolic Syndrome, sponsored by Karolinska Institutet. Completed at 1 site in Cameroon. Open to participants aged 21 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-09-03.

Sponsored by Karolinska Institutet · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
406
Ages
21 Years and older
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Malaria
  • Diabetes Mellitus
  • Metabolic Syndrome
  • Endemic
03

In context

Malaria

1,184 studies on the registry are indexed under Malaria; 79 are open to participants now.

This study's enrollment of 406 is below the median of 582 across 204 observational studies indexed under Malaria.

Browse Malaria studies →

Lead sponsor

Karolinska Institutet is the lead sponsor of 1,148 studies on the registry; 276 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
21 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

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.

Eligibility criteria

Inclusion Criteria: Age 21 years and above with diagnosis of type 2 diabetes -

Exclusion Criteria: pregnancy

-

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
406 participants (actual)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • 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

06

What researchers measure

Primary outcomes

  1. asymptomatic malaria

    malaria parasites detected by RDT/microscopy/PCR

    Time frame: 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

    Time frame: 1 year follow up

Other outcomes

  1. schistosoma infection

    detected schistosoma eggs in stool or urine by microscopy r PCR

    Time frame: 1 year follow up

  2. strongyloides infection

    Ab against S ratti detected by ELISA

    Time frame: 1 year follow up

07

Study locations

1 site
  • Limbe Regional Hospital
    Limbe, Cameroon
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 3, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06278181
Collaborators
University of Dschang, European Foundation for the Study of Diabetes
Responsible party
George Awungafac (Graduate Student, Karolinska Institutet) — Principal investigator
First posted
Feb 26, 2024
Start date
Sep 21, 2023
Primary completion
Mar 19, 2025
Completion
Mar 19, 2025
Last update
Sep 3, 2025

Study contacts

Katja Wyss, PhD MD
principal investigator · Karolinska Institutet

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Aug 2025. You cannot join it, but the record below documents what was studied.

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