Oral Endocannabinoids in People With Prediabetes and Diabetes

NCT ID: NCT06040164

Last Updated: 2023-09-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-10-01

Study Completion Date

2024-12-31

Brief Summary

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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

Detailed Description

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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.

Conditions

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PreDiabetes Diabetes Mellitus, Type 2 Obesity Oral Dysbiosis Mouth Disease

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Ob/Pre/H

obesity, prediabetes and healthy mouth

Observational study

Intervention Type OTHER

No intervention will be performed

Ob/Pre/OCD

obesity, prediabetes and oral cavity disease

Observational study

Intervention Type OTHER

No intervention will be performed

Ob/Diab/H

obesity, diabetes and healthy mouth

Observational study

Intervention Type OTHER

No intervention will be performed

Ob/Diab/OCD

obesity, diabetes and oral cavity disease

Observational study

Intervention Type OTHER

No intervention will be performed

Interventions

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Observational study

No intervention will be performed

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Francisco J Bermúdez-Silva, PhD

Role: PRINCIPAL_INVESTIGATOR

Hospital Regional Universitario de Málaga - FIMABIS

Central Contacts

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Rodolfo M Ortiz Flores, PhD

Role: CONTACT

951 29 03 43 / 951 03 01 17

Francisco J Bermúdez-Silva, PhD

Role: CONTACT

951 29 03 43 / 951 03 01 17

References

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Provided Documents

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Document Type: Study Protocol

View Document

Other Identifiers

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SMILE

Identifier Type: -

Identifier Source: org_study_id

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