This study evaluates the relationship of endocannabinoids in saliva with inflammation and oral dysbacteriosis present in people with periodontal disease and prediabetes/type 2 diabetes
Diabetes is a disease that affects millions of people worldwide, and the number of cases is expected to continue to increase in the coming years. Type 2 diabetes (T2D) is the most common form of diabetes and is closely related to prediabetes, a condition in which blood glucose levels are high but not high enough to be diagnosed as diabetes. Both prediabetes and T2D increase the risk of cardiovascular disease and are also associated with diseases of the oral cavity, such as dental caries and periodontal disease. The presence of pathogenic bacteria in the mouth has been linked to these diseases. The endocannabinoid system, a signaling system in the body that regulates various biological processes, has been found to play an important role in energy homeostasis and is implicated in obesity, prediabetes, and T2D. This study seeks to investigate the role of endocannabinoids and related lipids in diseases of the oral cavity in the context of prediabetes and T2D. A bidirectional relationship has been observed between periodontitis and T2D, with inflammation playing a central role in both diseases. Although subtle differences in the microbial composition of the mouth have been identified in people with diabetes, the exact mechanisms remain unclear. Our findings could open up a promising line of research on the therapeutic potential of cannabinoid drugs for the treatment of this type of complications in people with prediabetes/T2D.
Study Type
OBSERVATIONAL
Enrollment
60
No intervention will be performed
Change in 2-arachidonoyl-glycerol (2-AG) levels in saliva and plasma
Measured in pmol/ml
Time frame: Basal
Change in N-arachidonoylethanolamine (AEA) levels in saliva and plasma
Measured in pmol/ml
Time frame: Basal
Change in N-palmitoylethanolamine (PEA) levels in saliva and plasma
Measured in pmol/ml
Time frame: Basal
Change in N-oleoylethanolamine (OEA) levels in saliva and plasma
Measured in pmol/ml
Time frame: Basal
Change in N-palmitoylethanolamine (DHEA) levels in saliva and plasma
Measured in pmol/ml
Time frame: Basal
Change in 2-linoleoyl-glycerol (2-LG) levels in saliva and plasma
Measured in pmol/ml
Time frame: Basal
Change in 2-oleoyl-glycerol (2-OG) levels in saliva and plasma
Measured in pmol/ml
Time frame: Basal
Change in interleukin-1β levels in saliva and plasma
Measured in pmol/ml
Time frame: Basal
Change in interleukin-6 levels in saliva and plasma
Measured in pmol/ml
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Time frame: Basal
Change in interleukin-8 levels in saliva and plasma
Measured in pmol/ml
Time frame: Basal
Change in interleukin-10 levels in saliva and plasma
Measured in pmol/ml
Time frame: Basal
Change in interleukin-17 levels in saliva and plasma
Measured in pmol/ml
Time frame: Basal
Change in leptin levels in saliva and plasma
Measured in pmol/ml
Time frame: Basal
Change in vascular endothelial growth factor (VEGF) levels in saliva and plasma
Measured in pmol/ml
Time frame: Basal
Change in Interferon gamma (IFN)-γ levels in saliva and plasma
Measured in pmol/ml
Time frame: Basal
Change in Tumor necrosis factor alpha (TNF)-α levels in saliva and plasma
Measured in pmol/ml
Time frame: Basal
Changes in oral bacteriological profile
Bacterial 16S rRNA amplicon of the following bacterial strains: Aggregatibacter actinomycetemcomitans, Porphyromonas gingivalis, Tannerella forsythia, Treponema denticola, Prevotella intermedia, Fusobacterium nucleatum, Parvimonas micra, Campylobacter rectus, Eikenella corroe, Veillonella parvula and Actinomyces naeslundii for periodontal disease; and Streptococcus mutans, S. sanguis, S. mitior, S. salivarius and S. milleri for dental caries. Unit of Measurement: Fold-increase over reference genes, delta-delta Ct method.
Time frame: Basal
Changes in Fasting glucose levels
Measured in mg/dl
Time frame: Basal
Changes in insulin levels
Measured in mUI/mL
Time frame: Basal
Changes from baseline HOMA-IR levels
HOMA-IR = \[blood insulin (mu/L) × Blood glucose (mmol/L)\]/22.5
Time frame: Basal
Changes from baseline HOMA2-IR levels
The homeostasis model assessment computational method is used to estimate insulin resistance (HOMA2-IR) from fasting plasma glucose and insulin. The HOMA2-IR is the reciprocal of insulin sensitivity (%S), as a percentage of a normal reference population (normal young adult). A higher score indicates a lower insulin sensitivity.
Time frame: Basal
Changes from baseline HOMA2%S levels
Measured in %
Time frame: Basal
Changes from baseline HOMA2%B levels
Measured in %
Time frame: Basal
Changes from baseline QUICKY levels
QUICKY = 1 / (log(fasting insulin μU/mL) + log(fasting glucose mg/dL))
Time frame: Basal
Changes from baseline HbA1c levels
Measured in %
Time frame: Basal
BMI (body mass index) changes
Calculated as weight ⁄ height (kg/m2)
Time frame: Basal
Changes in waist circumference
Measured in cm
Time frame: Basal
Changes in waist/hip ratio
Calculated as waist measurement (cm) divided by hip measurement (cm) (W⁄H)
Time frame: Basal
Changes in waist/height ratio
Calculated as waist measurement (cm) divided by height measurement (cm), (W/He)
Time frame: Basal
Changes in blood pressure
Measured in mmHg
Time frame: Basal
Changes in triglycerides
Measured in mg/dL
Time frame: Basal
Changes in total cholesterol
Measured in mg/dL
Time frame: Basal
Changes in HDL cholesterol
Measured in mg/dL
Time frame: Basal
Changes in LDL cholesterol
Measured in mg/dL
Time frame: Basal
Changes in sialometry
Measured in mL/min
Time frame: Basal
Changes in salivary viscosity
Measured in poise (1 g·(s·cm)-1)
Time frame: Basal
Changes in salivary pH
Logarithm of hydrogen ion concentration
Time frame: Basal
Oral health impact profile
The Oral Health Impact Profile will be assessed by using the OHIP-14sp questionnaire, which is one of the most internationally spread indicators of oral health-related quality of life and it is used to measure the impact of oral conditions on quality of life to complement clinical data in cross-sectional and longitudinal studies. The OHIP-14 is a self-filled questionnaire that focuses on seven dimensions of impact (functional limitation, pain, psychological discomfort, physical disability, psychological disability, social disability and handicap) with participants being asked to respond according to frequency of impact on a 5-point Likert scale coded never (score 0), hardly ever (score 1), occasionally (score2), fairly often (score 3) and very often (score 4) using a twelve-months recall period.
Time frame: Basal