Clinical trial NCT06040164: Oral Endocannabinoids in People With Prediabetes and Diabetes
Official title: Molecular Study of Oral Dysbacteriosis in People With Prediabetes and Diabetes
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: PreDiabetes
Diabetes Mellitus, Type 2
Obesity
Oral Dysbiosis
Mouth Disease
Keywords: Endocannabinoids
Prediabetes
Diabetes Mellitus Type 2
Obesity
Oral Dysbiosis
Oral Disease
Cannabinoids
Lead sponsor: Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud
Sponsor class: OTHER
First posted: 2023-09-15
Enrollment: 60
Sex: ALL
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: The patients to enroll will come from three clinical studies led by our unit: The Pizarra study, an epidemiological study of the Endocrinology and Nutrition unit of the Regional Hospital of Malaga that has provided detailed information on anthropometric and biochemical parameters, eating habits and lifestyle in a cohort of about 1700 subjects; the di@bet.es study, a national epidemiological study carried out on a sample of more than 5,000 people; and the April study, a nutritional intervention study in people with obesity and prediabetes. In addition, the obesity databases of the Endocrinology and Nutrition unit of the Regional Hospital of Malaga will also be used.

Brief 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

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in 2-arachidonoyl-glycerol (2-AG) levels in saliva and plasma
timeFrame: Basal
measure: Change in N-arachidonoylethanolamine (AEA) levels in saliva and plasma
timeFrame: Basal
measure: Change in N-palmitoylethanolamine (PEA) levels in saliva and plasma
timeFrame: Basal
measure: Change in N-oleoylethanolamine (OEA) levels in saliva and plasma
timeFrame: Basal
measure: Change in N-palmitoylethanolamine (DHEA) levels in saliva and plasma
timeFrame: Basal
measure: Change in 2-linoleoyl-glycerol (2-LG) levels in saliva and plasma
timeFrame: Basal
measure: Change in 2-oleoyl-glycerol (2-OG) levels in saliva and plasma
timeFrame: Basal
Secondary outcomes:
measure: Change in interleukin-1β levels in saliva and plasma
timeFrame: Basal
measure: Change in interleukin-6 levels in saliva and plasma
timeFrame: Basal
measure: Change in interleukin-8 levels in saliva and plasma
timeFrame: Basal
measure: Change in interleukin-10 levels in saliva and plasma
timeFrame: Basal
measure: Change in interleukin-17 levels in saliva and plasma
timeFrame: Basal
measure: Change in leptin levels in saliva and plasma
timeFrame: Basal
measure: Change in vascular endothelial growth factor (VEGF) levels in saliva and plasma
timeFrame: Basal
measure: Change in Interferon gamma (IFN)-γ levels in saliva and plasma
timeFrame: Basal
measure: Change in Tumor necrosis factor alpha (TNF)-α levels in saliva and plasma
timeFrame: Basal
measure: Changes in oral bacteriological profile
timeFrame: Basal
measure: Changes in Fasting glucose levels
timeFrame: Basal
measure: Changes in insulin levels
timeFrame: Basal
measure: Changes from baseline HOMA-IR levels
timeFrame: Basal
measure: Changes from baseline HOMA2-IR levels
timeFrame: Basal
measure: Changes from baseline HOMA2%S levels
timeFrame: Basal
measure: Changes from baseline HOMA2%B levels
timeFrame: Basal
measure: Changes from baseline QUICKY levels
timeFrame: Basal
measure: Changes from baseline HbA1c levels
timeFrame: Basal
measure: BMI (body mass index) changes
timeFrame: Basal
measure: Changes in waist circumference
timeFrame: Basal
measure: Changes in waist/hip ratio
timeFrame: Basal
measure: Changes in waist/height ratio
timeFrame: Basal
measure: Changes in blood pressure
timeFrame: Basal
measure: Changes in triglycerides
timeFrame: Basal
measure: Changes in total cholesterol
timeFrame: Basal
measure: Changes in HDL cholesterol
timeFrame: Basal
measure: Changes in LDL cholesterol
timeFrame: Basal
measure: Changes in sialometry
timeFrame: Basal
measure: Changes in salivary viscosity
timeFrame: Basal
measure: Changes in salivary pH
timeFrame: Basal
measure: Oral health impact profile
timeFrame: Basal
Other outcomes:
Locations:
Study officials:
affiliation: Hospital Regional Universitario de Málaga - FIMABIS
name: Francisco J Bermúdez-Silva, PhD
role: PRINCIPAL_INVESTIGATOR
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