The primary objective of this study is to evaluate the diagnostic value of preselected salivary biomarkers known to be significantly elevated in individuals with obesity. This includes assessing their sensitivity and specificity to ensure their…
ID
Source
Brief title
Condition
- Diabetic complications
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary endpoints of this study are the diagnostic value of salivary
biomarkers, expressed as sensitivity and specificity and summarized by the area
under the receiver operating characteristic curve (AUROC), to evaluate their
ability in identifying metabolic dysregulations associated with obesity.
Secondary outcome
Secondary endpoints include investigating the association between clinical
characteristics (e.g., obesity severity, comorbidities, medication use),
demographic factors (e.g., age, gender, ethnicity) on the levels, sensitivity,
and specificity of salivary biomarkers. Additionally, proteomic technologies
using Olink will be used to further uncover the salivary proteomic profile of
obese individuals. This approach aims to identify novel biomarkers beyond those
highlighted in existing literature, offering new insights into the pathology of
obesity for future studies.
Background summary
Obesity, characterized by an abnormal accumulation of body fat and chronic
inflammations, leading to significant health risks including: type 2 diabetes,
cardiovascular disease, liver disease, periodontitis and certain cancers.
Despite these significant health risks, individuals with obesity often seek
medical help after symptoms of related complications become apparent, leading
to missed opportunities for early intervention.
Biomarkers, quantifiable biological indicators, are able to identify
obesity-related metabolic dysregulations before symptoms appear, enabling
earlier prevention and intervention. While blood is the gold standard for
biomarker analysis, saliva*s non-invasive nature makes it an attractive
alternative. The clinical application of salivary biomarkers however, remains
limited due to the lack of comprehensive evaluation of their diagnostic value,
a critical step for ensuring their sensitivity, specificity, and utility in
clinical practice.
For saliva to be recognized as a reliable diagnostic tool, its accuracy must be
proven to be comparable to that of blood measurements. If validated,
saliva-based testing could offer a non-invasive method for health monitoring,
potentially reducing or even eliminating the need for blood sampling. This
would be particularly beneficial for patients requiring frequent or long-term
monitoring, such as those with obesity and an elevated risk of metabolic
disorders. A saliva-based diagnostic approach could not only ease the burden on
patients but also enhance the accessibility of medical testing. By facilitating
the early detection of metabolic disorders and enabling targeted preventive
interventions, it may ultimately lead to improved health outcomes.
Study objective
The primary objective of this study is to evaluate the diagnostic value of
preselected salivary biomarkers known to be significantly elevated in
individuals with obesity. This includes assessing their sensitivity and
specificity to ensure their reliability and utility in identifying metabolic
dysregulations associated with obesity. Salivary results will be compared to
blood results, which serve as the reference standard, to establish the clinical
performance of saliva as a non-invasive alternative.
Study design
The study adopts a cross-sectional design comprising two distinct groups: an
obese group and a non-obese group. Participants, aged 18 to 65 years, will be
equally divided by gender and selected based on strict standard anthropometric
criteria, including Body Mass Index (BMI), Waist Circumference (WC), Fat Mass
Index (FMI) and Fat Free Mass Index (FFMI). Recruitment will be conducted in
collaboration with Utrecht University of Applied Sciences, the Academic Centre
for Dentistry Amsterdam, and healthcare professionals, who will approach
potential participants during routine consultations and provide detailed
information about the study. Saliva and blood samples will be collected.
Study burden and risks
Participation in this study poses minimal risk to both physical and mental
health. However, certain aspects of the study may involve some risks or
discomfort.
Potential Risks:
- Blood Sample Collection: Blood sampling will be performed by a trained
professional. Possible side effects include mild pain at the puncture site,
minor bruising, or, in rare cases, slight dizziness. These effects are
typically short-lived.
- Saliva Sample Collection: Collecting saliva is a simple and painless
procedure. There are no known risks or side effects associated with this method.
- Incidental Findings: If a test result suggests a potential medical condition,
the study physician will contact the participant to carefully explain the
findings. The participant will be advised to inform their physician for further
evaluation. If preferred, and with the participant*s consent, the study
physician may directly inform the physician. The participant*s consent for this
is documented in the informed consent form.
Approximately one week after this discussion, the researcher will follow up
with the participant to determine whether any further steps have been taken and
whether additional support is needed. If necessary, appropriate support will be
provided.
Heidelberglaan 7
Utrecht 3584 CS
NL
Heidelberglaan 7
Utrecht 3584 CS
NL
Listed location countries
Age
Inclusion criteria
1. Participants must be male or female, aged between 18 and 65 years at the
time of study
participation.
2. For the obese group, participants must have a body mass index (BMI) of >=
30.0 kg/m², while
participants in the non-obese group must have a BMI within the range of
18.5-24.9 kg/m².
3. Waist circumference (WC) must meet the following requirements:
a. For the obese group: WC of >= 102 cm for men or >= 88 cm for women.
b. For the non-obese group: WC of < 102 cm for men or < 88 cm for women.
4. Participants must meet the fat mass index criteria as specified in the study
protocol.
Exclusion criteria
1. Self-report or a doctor diagnosis of chronic diseases: cancer/ asthma/ COPD/
Gingivitis/ periodontitis/ Parkinson/ Type 1 diabetes/ kidney disease.
2. Chronic alcoholics
3. Currently an active smoker or residing in a household with smokers.
4. Pregnancy
5. Transgender
6. Sarcopenic obese, as defined in the study protocol.
7. History of bariatric surgery within the past 12 months.
8. Use of medications with anticholinergic effects, including antihistamines,
antipsychotics, or antidepressants.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL88809.041.25 |