Oral Endocannabinoids in People With Prediabetes and Diabetes

Obesity Clinical Trial

— SMILE  

Official title:

Molecular Study of Oral Dysbacteriosis in People With Prediabetes and Diabetes

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06040164
• Other study ID #: SMILE
• Status: Not yet recruiting
• Start date: October 1, 2023
• Est. completion date: December 31, 2024

Study information

• Verified date: March 2023
• Source: Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud
• Contact: Rodolfo M Ortiz Flores, PhD
• Phone: 951 29 03 43 / 951 03 01 17
• Email: rodolfo.ortiz[@]ibima.eu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Description:

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: December 31, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 65 Years

Eligibility

Inclusion Criteria:

• Adults, both sexes (40-65 years)
• With obesity and prediabetes: BMI 30-40 and HbA1c 5.7-6.4
• With obesity and diabetes: BMI 30-40 and previous diagnosis of diabetes

Exclusion Criteria:

• Pregnant women
• Diagnosis of some type of neoplasia or treated with radiotherapy and/or chemotherapy in the last year.
• Ongoing inflammatory diseases (Crohn's disease, ulcerative colitis, arthritis, etc.) and/or anti-inflammatory treatments
• Presence of systemic diseases of vital organs
• Participants in treatment with drugs that could alter salivary flow
• Smokers
• Participants who have not followed the specifications prior to sampling
• Participants who did not sign the informed consent

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Dysbiosis
• Glucose Intolerance
• Mouth Disease
• Mouth Diseases
• Obesity
• PreDiabetes
• Prediabetic State

Intervention

Other:
• Observational study
No intervention will be performed

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud

References & Publications (30)

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* Note: There are 30 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in 2-arachidonoyl-glycerol (2-AG) levels in saliva and plasma	Measured in pmol/ml	Basal
Primary	Change in N-arachidonoylethanolamine (AEA) levels in saliva and plasma	Measured in pmol/ml	Basal
Primary	Change in N-palmitoylethanolamine (PEA) levels in saliva and plasma	Measured in pmol/ml	Basal
Primary	Change in N-oleoylethanolamine (OEA) levels in saliva and plasma	Measured in pmol/ml	Basal
Primary	Change in N-palmitoylethanolamine (DHEA) levels in saliva and plasma	Measured in pmol/ml	Basal
Primary	Change in 2-linoleoyl-glycerol (2-LG) levels in saliva and plasma	Measured in pmol/ml	Basal
Primary	Change in 2-oleoyl-glycerol (2-OG) levels in saliva and plasma	Measured in pmol/ml	Basal
Secondary	Change in interleukin-1ß levels in saliva and plasma	Measured in pmol/ml	Basal
Secondary	Change in interleukin-6 levels in saliva and plasma	Measured in pmol/ml	Basal
Secondary	Change in interleukin-8 levels in saliva and plasma	Measured in pmol/ml	Basal
Secondary	Change in interleukin-10 levels in saliva and plasma	Measured in pmol/ml	Basal
Secondary	Change in interleukin-17 levels in saliva and plasma	Measured in pmol/ml	Basal
Secondary	Change in leptin levels in saliva and plasma	Measured in pmol/ml	Basal
Secondary	Change in vascular endothelial growth factor (VEGF) levels in saliva and plasma	Measured in pmol/ml	Basal
Secondary	Change in Interferon gamma (IFN)-? levels in saliva and plasma	Measured in pmol/ml	Basal
Secondary	Change in Tumor necrosis factor alpha (TNF)-a levels in saliva and plasma	Measured in pmol/ml	Basal
Secondary	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.	Basal
Secondary	Changes in Fasting glucose levels	Measured in mg/dl	Basal
Secondary	Changes in insulin levels	Measured in mUI/mL	Basal
Secondary	Changes from baseline HOMA-IR levels	HOMA-IR = [blood insulin (mu/L) × Blood glucose (mmol/L)]/22.5	Basal
Secondary	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.	Basal
Secondary	Changes from baseline HOMA2%S levels	Measured in %	Basal
Secondary	Changes from baseline HOMA2%B levels	Measured in %	Basal
Secondary	Changes from baseline QUICKY levels	QUICKY = 1 / (log(fasting insulin µU/mL) + log(fasting glucose mg/dL))	Basal
Secondary	Changes from baseline HbA1c levels	Measured in %	Basal
Secondary	BMI (body mass index) changes	Calculated as weight / height (kg/m2)	Basal
Secondary	Changes in waist circumference	Measured in cm	Basal
Secondary	Changes in waist/hip ratio	Calculated as waist measurement (cm) divided by hip measurement (cm) (W/H)	Basal
Secondary	Changes in waist/height ratio	Calculated as waist measurement (cm) divided by height measurement (cm), (W/He)	Basal
Secondary	Changes in blood pressure	Measured in mmHg	Basal
Secondary	Changes in triglycerides	Measured in mg/dL	Basal
Secondary	Changes in total cholesterol	Measured in mg/dL	Basal
Secondary	Changes in HDL cholesterol	Measured in mg/dL	Basal
Secondary	Changes in LDL cholesterol	Measured in mg/dL	Basal
Secondary	Changes in sialometry	Measured in mL/min	Basal
Secondary	Changes in salivary viscosity	Measured in poise (1 g·(s·cm)-1)	Basal
Secondary	Changes in salivary pH	Logarithm of hydrogen ion concentration	Basal
Secondary	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.	Basal