Oral Endocannabinoids in People With Prediabetes and Diabetes (SMILE)

September 13, 2023 updated by: Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud

Molecular Study of Oral Dysbacteriosis in People With Prediabetes and Diabetes

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Ob/Pre/H
obesity, prediabetes and healthy mouth
Other: Observational study
No intervention will be performed
Ob/Pre/OCD
obesity, prediabetes and oral cavity disease
Other: Observational study
No intervention will be performed
Ob/Diab/H
obesity, diabetes and healthy mouth
Other: Observational study
No intervention will be performed
Ob/Diab/OCD
obesity, diabetes and oral cavity disease
Other: Observational study
No intervention will be performed

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in 2-arachidonoyl-glycerol (2-AG) levels in saliva and plasma
Time Frame: Basal
Measured in pmol/ml
Basal
Change in N-arachidonoylethanolamine (AEA) levels in saliva and plasma
Time Frame: Basal
Measured in pmol/ml
Basal
Change in N-palmitoylethanolamine (PEA) levels in saliva and plasma
Time Frame: Basal
Measured in pmol/ml
Basal
Change in N-oleoylethanolamine (OEA) levels in saliva and plasma
Time Frame: Basal
Measured in pmol/ml
Basal
Change in N-palmitoylethanolamine (DHEA) levels in saliva and plasma
Time Frame: Basal
Measured in pmol/ml
Basal
Change in 2-linoleoyl-glycerol (2-LG) levels in saliva and plasma
Time Frame: Basal
Measured in pmol/ml
Basal
Change in 2-oleoyl-glycerol (2-OG) levels in saliva and plasma
Time Frame: Basal
Measured in pmol/ml
Basal

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in interleukin-1β levels in saliva and plasma
Time Frame: Basal
Measured in pmol/ml
Basal
Change in interleukin-6 levels in saliva and plasma
Time Frame: Basal
Measured in pmol/ml
Basal
Change in interleukin-8 levels in saliva and plasma
Time Frame: Basal
Measured in pmol/ml
Basal
Change in interleukin-10 levels in saliva and plasma
Time Frame: Basal
Measured in pmol/ml
Basal
Change in interleukin-17 levels in saliva and plasma
Time Frame: Basal
Measured in pmol/ml
Basal
Change in leptin levels in saliva and plasma
Time Frame: Basal
Measured in pmol/ml
Basal
Change in vascular endothelial growth factor (VEGF) levels in saliva and plasma
Time Frame: Basal
Measured in pmol/ml
Basal
Change in Interferon gamma (IFN)-γ levels in saliva and plasma
Time Frame: Basal
Measured in pmol/ml
Basal
Change in Tumor necrosis factor alpha (TNF)-α levels in saliva and plasma
Time Frame: Basal
Measured in pmol/ml
Basal
Changes in oral bacteriological profile
Time Frame: Basal
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
Changes in Fasting glucose levels
Time Frame: Basal
Measured in mg/dl
Basal
Changes in insulin levels
Time Frame: Basal
Measured in mUI/mL
Basal
Changes from baseline HOMA-IR levels
Time Frame: Basal
HOMA-IR = [blood insulin (mu/L) × Blood glucose (mmol/L)]/22.5
Basal
Changes from baseline HOMA2-IR levels
Time Frame: Basal
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
Changes from baseline HOMA2%S levels
Time Frame: Basal
Measured in %
Basal
Changes from baseline HOMA2%B levels
Time Frame: Basal
Measured in %
Basal
Changes from baseline QUICKY levels
Time Frame: Basal
QUICKY = 1 / (log(fasting insulin μU/mL) + log(fasting glucose mg/dL))
Basal
Changes from baseline HbA1c levels
Time Frame: Basal
Measured in %
Basal
BMI (body mass index) changes
Time Frame: Basal
Calculated as weight ⁄ height (kg/m2)
Basal
Changes in waist circumference
Time Frame: Basal
Measured in cm
Basal
Changes in waist/hip ratio
Time Frame: Basal
Calculated as waist measurement (cm) divided by hip measurement (cm) (W⁄H)
Basal
Changes in waist/height ratio
Time Frame: Basal
Calculated as waist measurement (cm) divided by height measurement (cm), (W/He)
Basal
Changes in blood pressure
Time Frame: Basal
Measured in mmHg
Basal
Changes in triglycerides
Time Frame: Basal
Measured in mg/dL
Basal
Changes in total cholesterol
Time Frame: Basal
Measured in mg/dL
Basal
Changes in HDL cholesterol
Time Frame: Basal
Measured in mg/dL
Basal
Changes in LDL cholesterol
Time Frame: Basal
Measured in mg/dL
Basal
Changes in sialometry
Time Frame: Basal
Measured in mL/min
Basal
Changes in salivary viscosity
Time Frame: Basal
Measured in poise (1 g·(s·cm)-1)
Basal
Changes in salivary pH
Time Frame: Basal
Logarithm of hydrogen ion concentration
Basal
Oral health impact profile
Time Frame: Basal
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Francisco J Bermúdez-Silva, PhD, Hospital Regional Universitario de Málaga - FIMABIS

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 19, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 13, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 15, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 15, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 13, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SMILE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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