NCT05685875

Brief Summary

The aim of this study is to investigate if diabetes, obesity and metabolic syndrome affects disease presentation and severity of malaria in adults in a hospital setting in Cameroon.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2022

Shorter than P25 for all trials

Geographic Reach
1 country

2 active sites

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 7, 2022

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

November 11, 2022

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 17, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2023

Completed
Last Updated

January 17, 2023

Status Verified

January 1, 2023

Enrollment Period

11 months

First QC Date

November 11, 2022

Last Update Submit

January 12, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • Severe malaria

    P falciparum or other malaria species identified by microscopy and one or more criteria for severe malaria according to WHO 2015 definition.

    1 year

Secondary Outcomes (3)

  • Malaria requiring in-patient care

    1 year

  • Cerebral malaria

    1 year

  • Severe malaria with kidney failure

    1 year

Interventions

Diabetes and metabolic syndrome defined using criteria by IDF. Obesity defined as BMI\>=30

Also known as: obesity, metabolic syndrome

Eligibility Criteria

Age20 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Adults, \>=20 years diagnosed with malaria (all Plasmodium species), will be recruited prospectively at both the outpatient department (OD), emergency department (ED) and hospital wards in Dschang and Bafoussam hospital. The malaria diagnosis can initially be by rapid test but should be confirmed by microscopy (for sepcies determination and parasite count). Patients will be invited to participate in the study after they return from laboratory investigations following routine consultation at the ED/OD if they have a positive malaria result. Participant recruitment will be conducted daily during normal work hours until the estimated study sample is attained. Patients that have seeked health care outside office hours and been admitted for malaria will be recruited the following day.

You may qualify if:

  • Adults 20 years and above
  • Diagnosed with malaria (all Plasmodium species, confirmed by microscopy)
  • Have given consent to participate in the study

You may not qualify if:

  • Children/youths \<20 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Dschang Hospital

Dschang, West Cameroon, 43, Cameroon

RECRUITING

Bafoussam Regional Hospital

Bafoussam, West Region, 997, Cameroon

NOT YET RECRUITING

Related Publications (5)

  • Wyss K, Wangdahl A, Vesterlund M, Hammar U, Dashti S, Naucler P, Farnert A. Obesity and Diabetes as Risk Factors for Severe Plasmodium falciparum Malaria: Results From a Swedish Nationwide Study. Clin Infect Dis. 2017 Sep 15;65(6):949-958. doi: 10.1093/cid/cix437.

    PMID: 28510633BACKGROUND
  • Danquah I, Bedu-Addo G, Mockenhaupt FP. Type 2 diabetes mellitus and increased risk for malaria infection. Emerg Infect Dis. 2010 Oct;16(10):1601-4. doi: 10.3201/eid1610.100399.

    PMID: 20875289BACKGROUND
  • Sun H, Saeedi P, Karuranga S, Pinkepank M, Ogurtsova K, Duncan BB, Stein C, Basit A, Chan JCN, Mbanya JC, Pavkov ME, Ramachandaran A, Wild SH, James S, Herman WH, Zhang P, Bommer C, Kuo S, Boyko EJ, Magliano DJ. IDF Diabetes Atlas: Global, regional and country-level diabetes prevalence estimates for 2021 and projections for 2045. Diabetes Res Clin Pract. 2022 Jan;183:109119. doi: 10.1016/j.diabres.2021.109119. Epub 2021 Dec 6.

    PMID: 34879977BACKGROUND
  • Guidelines for the Treatment of Malaria. 3rd edition. Geneva: World Health Organization; 2015. Available from http://www.ncbi.nlm.nih.gov/books/NBK294440/

    PMID: 26020088BACKGROUND
  • Alberti KG, Zimmet P, Shaw J. Metabolic syndrome--a new world-wide definition. A Consensus Statement from the International Diabetes Federation. Diabet Med. 2006 May;23(5):469-80. doi: 10.1111/j.1464-5491.2006.01858.x.

    PMID: 16681555BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Venous blood samples for biochemistry analyses, malaria detection and Ag/serology (HIV) test

MeSH Terms

Conditions

Diabetes Mellitus, Type 2ObesityMetabolic SyndromeMalariaMalaria, Falciparum

Interventions

AdiposityANAPC16 protein, human

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesOverweightOvernutritionNutrition DisordersBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsInsulin ResistanceHyperinsulinismProtozoan InfectionsParasitic DiseasesInfectionsMosquito-Borne DiseasesVector Borne Diseases

Intervention Hierarchy (Ancestors)

Body Fat DistributionBody Weights and MeasuresBody ConstitutionPhysical ExaminationDiagnostic Techniques and ProceduresDiagnosisBody CompositionBiochemical PhenomenaChemical PhenomenaMetabolismPhysiological Phenomena

Study Officials

  • Anna Färnert, Prof

    Karolinska Institutet

    STUDY DIRECTOR

Central Study Contacts

Katja Wyss, PhD, MD

CONTACT

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
prinicpal investigator

Study Record Dates

First Submitted

November 11, 2022

First Posted

January 17, 2023

Study Start

June 7, 2022

Primary Completion

May 1, 2023

Study Completion

June 1, 2023

Last Updated

January 17, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will not share

Locations