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Association of Diabetes and Metabolic Syndrome With Severe Malaria in Cameroon

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ClinicalTrials.gov Identifier: NCT05685875
Recruitment Status : Recruiting
First Posted : January 17, 2023
Last Update Posted : January 17, 2023
Sponsor:
Collaborator:
University of Dschang
Information provided by (Responsible Party):
Katja Wyss, Karolinska Institutet

Study Description
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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.

Condition or disease Intervention/treatment
Diabetes Mellitus, Type 2 Obesity Metabolic Syndrome Severe Malaria Malaria,Falciparum Other: diabetes

Detailed Description:

Malaria is a major global health problem affecting approximately 241 million people and causing more than 600 thousand deaths, according to the latest WHO estimates. In parallel non-communicable life style diseases increase globally, also in malaria-endemic areas. Surprisingly few studies have investigated possible associations between malaria and non-communicable diseases. Higher prevalence of asymptomatic malaria infection has been shown among individuals with type 2 diabetes in Ghana and the risk of malaria increased with poor glucose control. In a recent study on more than 900 adults with P. falciparum malaria in Sweden, comorbidities and especially diabetes, metabolic syndrome and obesity were associated with a 3-5 times increased risk of severe malaria . Interestingly, these associations were apparent also in African immigrants, a group otherwise recognized to be at reduced risk of severe malaria due to pre-existing immunity. Altered metabolism and chronic inflammatory state in individuals with obesity and diabetes might affect severe progression of malaria. Moreover, poor antibody responses have been observed in obese individuals vaccinated against viral and bacterial infections; and impaired antibody mediated immunity might also affect the risk of malaria.

The overall aim of this project is to investigate whether diabetes, obesity and the metabolic syndrome affects the risk of severe malaria in an endemic setting.

The study will be performed at the District Hospital Dschang and the Bafoussam Regional Hospital in Western Cameroon. Adults diagnosed with malaria at the two hospitals, both at the outpatient clinic and admitted to the hospital wards, will be invited to participate in the study. Informed consent is needed for inclusion. The participants will be clinically evaluated for diabetes and the metabolic syndrome according to International Diabetes Federation (IDF) criteria. In addition to lab parameters below, weight and height will be measured for body mass index (BMI). Severe malaria will be defined according to WHO criteria.

Malaria species and parasite density will be assessed by microscopy of blood films stained with Giemsa. Clinical chemistry will include a fasting plasma glucose, glycated haemoglobin (HBA1c), lipids, erythrocyte sedimentation rate (ESR), liver enzymes, bilirubin, creatinine and haemoglobinopathies such as sickle cell will be assessed. HIV test will be offered to all patients. For patients admitted to hospital, fasting plasma glucose, parasitaemia and insulin levels will be measured on a daily basis. Venous EDTA blood sample will be collected at admission and stored frozen as plasma and packed cells for later PCR confirmation.

Study Design
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Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Malaria, Diabetes and Metabolic Syndrome: Investigating the Double Burden of Diseases in Cameroon
Actual Study Start Date : June 7, 2022
Estimated Primary Completion Date : May 2023
Estimated Study Completion Date : June 2023

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Intervention Details:
  • Other: diabetes
    Diabetes and metabolic syndrome defined using criteria by IDF. Obesity defined as BMI>=30
    Other Names:
    • obesity
    • metabolic syndrome

Outcome Measures
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Primary Outcome Measures :
  1. Severe malaria [ Time Frame: 1 year ]
    P falciparum or other malaria species identified by microscopy and one or more criteria for severe malaria according to WHO 2015 definition.


Secondary Outcome Measures :
  1. Malaria requiring in-patient care [ Time Frame: 1 year ]
    Patients with confirmed malaria admitted to hospital

  2. Cerebral malaria [ Time Frame: 1 year ]
    Confirmed malaria and Glasgow Coma Scale <11

  3. Severe malaria with kidney failure [ Time Frame: 1 year ]
    Confirmed malaria and Creatinine >265


Biospecimen Retention:   Samples With DNA
Venous blood samples for biochemistry analyses, malaria detection and Ag/serology (HIV) test

Eligibility Criteria
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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Probability 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.

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Children/youths <20 years
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05685875


Contacts
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Contact: Katja Wyss, PhD, MD +46707352767 katja.wyss@ki.se

Locations
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Cameroon
Dschang Hospital Recruiting
Dschang, West Cameroon, Cameroon, 43
Contact: George Awungafac, MD    +23779750125    awungafacg@yahoo.com   
Bafoussam Regional Hospital Not yet recruiting
Bafoussam, West Region, Cameroon, 997
Contact: George Awungafac, MD    +23779750125    awungafacg@yahoo.com   
Sponsors and Collaborators
Karolinska Institutet
University of Dschang
Investigators
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Study Director: Anna Färnert, Prof Karolinska Institutet
More Information
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Publications:

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Responsible Party: Katja Wyss, prinicpal investigator, Karolinska Institutet
ClinicalTrials.gov Identifier: NCT05685875    
Other Study ID Numbers: 2022-05379-01
2020-05494 ( Other Grant/Funding Number: Swedish Research Council )
First Posted: January 17, 2023    Key Record Dates
Last Update Posted: January 17, 2023
Last Verified: January 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Malaria
Malaria, Falciparum
Metabolic Syndrome
Syndrome
Disease
Pathologic Processes
Glucose Metabolism Disorders
 Metabolic Diseases
Endocrine System Diseases
Protozoan Infections
Parasitic Diseases
Infections
Vector Borne Diseases
Insulin Resistance
Hyperinsulinism