Association of Diabetes and Metabolic Syndrome With Severe Malaria in Cameroon

NCT ID: NCT05685875

Last Updated: 2023-01-17

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 300 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-06-07
• Study Completion Date: 2023-06-30

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.

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.

Conditions

Diabetes Mellitus, Type 2; Obesity; Metabolic Syndrome; Severe Malaria; Malaria,Falciparum

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Interventions

diabetes

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

Intervention Type: OTHER

Other Intervention Names

obesity; metabolic syndrome

Eligibility 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

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Dschang

OTHER

Sponsor Role: collaborator

Karolinska Institutet

OTHER

Sponsor Role: lead

Responsible Party

Katja Wyss

prinicpal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Anna Färnert, Prof

Role: STUDY_DIRECTOR

Karolinska Institutet

Locations

Dschang Hospital

Dschang, West Cameroon, Cameroon

Site Status: RECRUITING

Bafoussam Regional Hospital

Bafoussam, West Region, Cameroon

Site Status: NOT_YET_RECRUITING

Countries

Cameroon

Central Contacts

Katja Wyss, PhD, MD

Role: CONTACT

katja.wyss@ki.se

+46707352767

Facility Contacts

George Awungafac, MD

Role: primary

awungafacg@yahoo.com

+23779750125

George Awungafac, MD

Role: primary

awungafacg@yahoo.com

+23779750125

References

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.

Reference Type: BACKGROUND

PMID: 28510633 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 20875289 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 34879977 (View on PubMed)

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

Reference Type: BACKGROUND

PMID: 26020088 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 16681555 (View on PubMed)

Other Identifiers

2020-05494

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

2022-05379-01

Identifier Type: -

Identifier Source: org_study_id