Oral Endocannabinoids in People With Prediabetes and Diabetes (SMILE)

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

Status

Not yet enrolling

Conditions

Mouth Disease

Oral Dysbiosis

Obesity

Diabetes Mellitus, Type 2

PreDiabetes

Treatments

Other: Observational study

Study type

Observational

Funder types

Other

Identifiers

NCT06040164

SMILE

Details and patient eligibility

About

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

Full 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.

Enrollment

60 estimated patients

Sex

All

Ages

40 to 65 years old

Volunteers

No Healthy Volunteers

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