NCT06278181

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
406

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 21, 2023

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

February 19, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 26, 2024

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 19, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 19, 2025

Completed
Last Updated

September 3, 2025

Status Verified

August 1, 2025

Enrollment Period

1.5 years

First QC Date

February 19, 2024

Last Update Submit

August 26, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • asymptomatic malaria

    malaria parasites detected by RDT/microscopy/PCR

    1 year follow up

Secondary Outcomes (1)

  • symptomatic malaria

    1 year follow up

Other Outcomes (2)

  • schistosoma infection

    1 year follow up

  • strongyloides infection

    1 year follow up

Study Arms (2)

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

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Limbe Regional Hospital

Limbe, Cameroon

Location

Biospecimen

Retention: SAMPLES WITH DNA

Venous EDTA blood sample will be collected at admission and stored frozen as plasma and packed cells for later analyses

MeSH Terms

Conditions

MalariaDiabetes MellitusMetabolic SyndromeBurkitt Lymphoma

Condition Hierarchy (Ancestors)

Protozoan InfectionsParasitic DiseasesInfectionsMosquito-Borne DiseasesVector Borne DiseasesGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesInsulin ResistanceHyperinsulinismEpstein-Barr Virus InfectionsHerpesviridae InfectionsDNA Virus InfectionsVirus DiseasesTumor Virus InfectionsLymphoma, B-CellLymphoma, Non-HodgkinLymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Study Officials

  • Katja Wyss, PhD MD

    Karolinska Institutet

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Graduate Student

Study Record Dates

First Submitted

February 19, 2024

First Posted

February 26, 2024

Study Start

September 21, 2023

Primary Completion

March 19, 2025

Study Completion

March 19, 2025

Last Updated

September 3, 2025

Record last verified: 2025-08

Locations