Association of Diabetes and Metabolic Syndrome With Severe Malaria in Cameroon

Obesity Clinical Trial

Official title:

Malaria, Diabetes and Metabolic Syndrome: Investigating the Double Burden of Diseases in Cameroon

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05685875
• Other study ID #: 2022-05379-01
• Secondary ID: 2020-05494
• Status: Recruiting
• Start date: June 7, 2022
• Est. completion date: June 2023

Study information

• Verified date: January 2023
• Source: Karolinska Institutet
• Contact: Katja Wyss, PhD, MD
• Phone: +46707352767
• Email: katja.wyss[@]ki.se
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: June 2023
• Est. primary completion date: May 2023
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Other:
• diabetes
Diabetes and metabolic syndrome defined using criteria by IDF. Obesity defined as BMI>=30

Locations

Country	Name	City	State
Cameroon	Bafoussam Regional Hospital	Bafoussam	West Region
Cameroon	Dschang Hospital	Dschang	West Cameroon

Sponsors (2)

Lead Sponsor	Collaborator
Karolinska Institutet	University of Dschang

Country where clinical trial is conducted

Cameroon, 

References & Publications (5)

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. — View Citation

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. — View Citation

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

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Malaria requiring in-patient care	Patients with confirmed malaria admitted to hospital	1 year
Secondary	Cerebral malaria	Confirmed malaria and Glasgow Coma Scale <11	1 year
Secondary	Severe malaria with kidney failure	Confirmed malaria and Creatinine >265	1 year