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Diabetes Mellitus, Type 2NCT05685875

Association of Diabetes and Metabolic Syndrome With Severe Malaria in Cameroon

An observational study of Diabetes Mellitus, Type 2 and Obesity, run by Karolinska Institutet at 2 sites in Cameroon.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 20 years and older
What is being tested?
diabetes
How many people
300 participants
Where
2 sitesCameroon
Study dates
7 Jun 2022to Jun 2023
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 years and older
  • All sexes
  • Adult, Older adult

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.

Who may be able to join

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

Who cannot join

  • Children/youths <20 years

Trial locations and contacts

2 sites in 1 country.

Katja Wyss, PhD, MD contact

+46707352767

katja.wyss@ki.se

Cameroon2 sites, 2 recruiting

  • Bafoussam Regional Hospital

    Bafoussam, West Region, 997

    George Awungafac, MD, +23779750125, awungafacg@yahoo.com

    Not yet recruiting

  • Dschang Hospital

    Dschang, West Cameroon, 43

    George Awungafac, MD, +23779750125, awungafacg@yahoo.com

    Recruiting

Other trials in Cameroon

About this study

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

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.

Read the 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.

Being tested
diabetes
Medical subject headings
Diabetes Mellitus, Type 2, Obesity, Metabolic Syndrome, Malaria, Malaria, Falciparum

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • diabetesOther

    Also called obesity, metabolic syndrome

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

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 1 year

Secondary outcomes (3)

  1. Malaria requiring in-patient care

    Patients with confirmed malaria admitted to hospital

    Measured: 1 year

  2. Cerebral malaria

    Confirmed malaria and Glasgow Coma Scale <11

    Measured: 1 year

  3. Severe malaria with kidney failure

    Confirmed malaria and Creatinine >265

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Jan 2023
  2. Study start7 Jun 2022
  3. Primary completionMay 2023 (estimated)
  4. Study completionJun 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Prospective
Enrolment
300 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05685875
Sponsor's protocol ID
2022-05379-01
Other IDs
2020-05494
Status last verified
Jan 2023
First submitted
11 Nov 2022
Last updated
17 Jan 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 28510633

  • 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.

    PubMed 20875289

  • 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.

    PubMed 34879977

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

    PubMed 26020088

  • 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.

    PubMed 16681555

Questions about this trial

What is this clinical trial studying?

An observational study of Diabetes Mellitus, Type 2 and Obesity, run by Karolinska Institutet at 2 sites in Cameroon.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 17 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Cameroon. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Katja Wyss, PhD, MD (+46707352767, katja.wyss@ki.se), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Severe malaria (time frame: 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05685875, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jan 2023.

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