PreDiabetesSMILENCT06040164
Oral Endocannabinoids in People With Prediabetes and Diabetes
An observational study of PreDiabetes and Diabetes Mellitus, Type 2, run by Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud.
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 Read more about this study
- Who is it for?
- Ages 40 to 65 years
- Conditions the study is for
- PreDiabetes, Diabetes Mellitus, Type 2, Obesity
- What is being tested?
- Observational study
- Type of treatment
- Pill or oral medicine
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2023to 31 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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
Read the 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.
- Conditions
- PreDiabetes, Diabetes Mellitus, Type 2, Obesity, Oral Dysbiosis, Mouth Disease
- Being tested
- Observational study
- Keywords
- Endocannabinoids, Prediabetes, Diabetes Mellitus Type 2, Obesity, Oral Dysbiosis, Oral Disease, Cannabinoids
- Medical subject headings
- Prediabetic State, Diabetes Mellitus, Type 2, Obesity, Mouth Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observational studyOther
No intervention will be performed
| Study group | Role | What they receive |
|---|---|---|
| Ob/Pre/H | obesity, prediabetes and healthy mouth Receives: Other: Observational study | |
| Ob/Pre/OCD | obesity, prediabetes and oral cavity disease Receives: Other: Observational study | |
| Ob/Diab/H | obesity, diabetes and healthy mouth Receives: Other: Observational study | |
| Ob/Diab/OCD | obesity, diabetes and oral cavity disease Receives: Other: Observational study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in 2-arachidonoyl-glycerol (2-AG) levels in saliva and plasma
Measured in pmol/ml
Measured: Basal
Change in N-arachidonoylethanolamine (AEA) levels in saliva and plasma
Measured in pmol/ml
Measured: Basal
Change in N-palmitoylethanolamine (PEA) levels in saliva and plasma
Measured in pmol/ml
Measured: Basal
Change in N-oleoylethanolamine (OEA) levels in saliva and plasma
Measured in pmol/ml
Measured: Basal
Change in N-palmitoylethanolamine (DHEA) levels in saliva and plasma
Measured in pmol/ml
Measured: Basal
Change in 2-linoleoyl-glycerol (2-LG) levels in saliva and plasma
Measured in pmol/ml
Measured: Basal
Change in 2-oleoyl-glycerol (2-OG) levels in saliva and plasma
Measured in pmol/ml
Measured: Basal
Secondary outcomes (31)
Change in interleukin-1β levels in saliva and plasma
Measured in pmol/ml
Measured: Basal
Change in interleukin-6 levels in saliva and plasma
Measured in pmol/ml
Measured: Basal
Change in interleukin-8 levels in saliva and plasma
Measured in pmol/ml
Measured: Basal
Change in interleukin-10 levels in saliva and plasma
Measured in pmol/ml
Measured: Basal
Change in interleukin-17 levels in saliva and plasma
Measured in pmol/ml
Measured: Basal
Change in leptin levels in saliva and plasma
Measured in pmol/ml
Measured: Basal
Change in vascular endothelial growth factor (VEGF) levels in saliva and plasma
Measured in pmol/ml
Measured: Basal
Change in Interferon gamma (IFN)-γ levels in saliva and plasma
Measured in pmol/ml
Measured: Basal
Change in Tumor necrosis factor alpha (TNF)-α levels in saliva and plasma
Measured in pmol/ml
Measured: Basal
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.
Measured: Basal
Changes in Fasting glucose levels
Measured in mg/dl
Measured: Basal
Changes in insulin levels
Measured in mUI/mL
Measured: Basal
Changes from baseline HOMA-IR levels
HOMA-IR = [blood insulin (mu/L) × Blood glucose (mmol/L)]/22.5
Measured: Basal
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.
Measured: Basal
Changes from baseline HOMA2%S levels
Measured in %
Measured: Basal
Changes from baseline HOMA2%B levels
Measured in %
Measured: Basal
Changes from baseline QUICKY levels
QUICKY = 1 / (log(fasting insulin μU/mL) + log(fasting glucose mg/dL))
Measured: Basal
Changes from baseline HbA1c levels
Measured in %
Measured: Basal
BMI (body mass index) changes
Calculated as weight ⁄ height (kg/m2)
Measured: Basal
Changes in waist circumference
Measured in cm
Measured: Basal
Changes in waist/hip ratio
Calculated as waist measurement (cm) divided by hip measurement (cm) (W⁄H)
Measured: Basal
Changes in waist/height ratio
Calculated as waist measurement (cm) divided by height measurement (cm), (W/He)
Measured: Basal
Changes in blood pressure
Measured in mmHg
Measured: Basal
Changes in triglycerides
Measured in mg/dL
Measured: Basal
Changes in total cholesterol
Measured in mg/dL
Measured: Basal
Changes in HDL cholesterol
Measured in mg/dL
Measured: Basal
Changes in LDL cholesterol
Measured in mg/dL
Measured: Basal
Changes in sialometry
Measured in mL/min
Measured: Basal
Changes in salivary viscosity
Measured in poise (1 g·(s·cm)-1)
Measured: Basal
Changes in salivary pH
Logarithm of hydrogen ion concentration
Measured: Basal
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.
Measured: Basal
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2023
- Study start1 Oct 2023 (estimated)
- Primary completion30 Jun 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (30)Papers the sponsor has linked to this study.
- Other trials for PreDiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Francisco J Bermúdez-Silva, PhD, Principal investigator, Hospital Regional Universitario de Málaga - FIMABIS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06040164
- Sponsor's protocol ID
- SMILE
- Acronym
- SMILE
- Status last verified
- Mar 2023
- First submitted
- 19 Jul 2023
- Last updated
- 15 Sep 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
IDF Diabetes Atlas 10th edition. Accessed September 29, 2022. www.diabetesatlas.org
Aleixandre MA, Miguel M. Síndrome metabólico. Endocrinologia y Nutricion. 2007;54(9). doi:10.1016/S1575-0922(07)71487-0
Reaven GM. Banting lecture 1988. Role of insulin resistance in human disease. Diabetes. 1988 Dec;37(12):1595-607. doi: 10.2337/diab.37.12.1595.
PubMed 3056758Bissett SM, Stone KM, Rapley T, Preshaw PM. An exploratory qualitative interview study about collaboration between medicine and dentistry in relation to diabetes management. BMJ Open. 2013 Feb 14;3(2):e002192. doi: 10.1136/bmjopen-2012-002192. Print 2013.
PubMed 23418299Tavares RDCR, Ortigara GB, Tatsch KF, Ferreira CM, Boligon J, Moreira CHC. Association between periodontitis and glycated hemoglobin levels in individuals living in rural Southern Brazil. Clin Oral Investig. 2021 Dec;25(12):6901-6907. doi: 10.1007/s00784-021-03980-y. Epub 2021 May 31.
PubMed 34059955Kriebel K, Hieke C, Muller-Hilke B, Nakata M, Kreikemeyer B. Oral Biofilms from Symbiotic to Pathogenic Interactions and Associated Disease -Connection of Periodontitis and Rheumatic Arthritis by Peptidylarginine Deiminase. Front Microbiol. 2018 Jan 30;9:53. doi: 10.3389/fmicb.2018.00053. eCollection 2018.
PubMed 29441048Canepari P, Zerman N, Cavalleri G. Lack of correlation between salivary Streptococcus mutans and lactobacilli counts and caries in IDDM children. Minerva Stomatol. 1994 Nov;43(11):501-5.
PubMed 7739481Estrich CG, Araujo MWB, Lipman RD. Prediabetes and Diabetes Screening in Dental Care Settings: NHANES 2013 to 2016. JDR Clin Trans Res. 2019 Jan;4(1):76-85. doi: 10.1177/2380084418798818. Epub 2018 Sep 6.
PubMed 30596147Kocher T, Holtfreter B, Petersmann A, Eickholz P, Hoffmann T, Kaner D, Kim TS, Meyle J, Schlagenhauf U, Doering S, Gravemeier M, Prior K, Rathmann W, Harks I, Ehmke B, Koch R. Effect of Periodontal Treatment on HbA1c among Patients with Prediabetes. J Dent Res. 2019 Feb;98(2):171-179. doi: 10.1177/0022034518804185. Epub 2018 Oct 16.
PubMed 30326764Artur C, Otto-Buczkowska E (2014) Oral Health Problems among Diabetic Patients - Part of Dental Professionals in Diagnostic and Therapy. J Oral Hyg Health 2:167. doi:10.4172/2332-0702.1000167
Di Marzo V, Silvestri C. Lifestyle and Metabolic Syndrome: Contribution of the Endocannabinoidome. Nutrients. 2019 Aug 20;11(8):1956. doi: 10.3390/nu11081956.
PubMed 31434293Gatta-Cherifi B, Cota D. New insights on the role of the endocannabinoid system in the regulation of energy balance. Int J Obes (Lond). 2016 Feb;40(2):210-9. doi: 10.1038/ijo.2015.179. Epub 2015 Sep 16.
PubMed 26374449Bermudez-Silva FJ, Cardinal P, Cota D. The role of the endocannabinoid system in the neuroendocrine regulation of energy balance. J Psychopharmacol. 2012 Jan;26(1):114-24. doi: 10.1177/0269881111408458. Epub 2011 Aug 8.
PubMed 21824982Di Marzo V. New approaches and challenges to targeting the endocannabinoid system. Nat Rev Drug Discov. 2018 Sep;17(9):623-639. doi: 10.1038/nrd.2018.115. Epub 2018 Aug 17.
PubMed 30116049Hillard CJ. Circulating Endocannabinoids: From Whence Do They Come and Where are They Going? Neuropsychopharmacology. 2018 Jan;43(1):155-172. doi: 10.1038/npp.2017.130. Epub 2017 Jun 27.
PubMed 28653665
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Molecular Study of Oral Dysbacteriosis in People With Prediabetes and Diabetes
- ClinicalTrials.gov ID
- NCT06040164
- Acronym / sponsor ID
- SMILE / SMILE
- Conditions
- PreDiabetes, Diabetes Mellitus, Type 2, Obesity, Oral Dysbiosis, Mouth Disease
- Keywords
- Endocannabinoids, Prediabetes, Diabetes Mellitus Type 2, Obesity, Oral Dysbiosis, Oral Disease, Cannabinoids
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y SaludUniversity, hospital or other
- Study start
- 1 Oct 2023 (estimated)
- Primary completion
- 30 Jun 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 15 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Ob/Pre/H | – | Other: Observational studyobesity, prediabetes and healthy mouth |
| Ob/Pre/OCD | – | Other: Observational studyobesity, prediabetes and oral cavity disease |
| Ob/Diab/H | – | Other: Observational studyobesity, diabetes and healthy mouth |
| Ob/Diab/OCD | – | Other: Observational studyobesity, diabetes and oral cavity disease |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Observational studyNo intervention will be performed | Other | Ob/Diab/H, Ob/Diab/OCD, Ob/Pre/H, Ob/Pre/OCD |
Primary outcome
Change in 2-arachidonoyl-glycerol (2-AG) levels in saliva and plasma
Time frame: Basal
Measured in pmol/ml
Change in N-arachidonoylethanolamine (AEA) levels in saliva and plasma
Time frame: Basal
Measured in pmol/ml
Change in N-palmitoylethanolamine (PEA) levels in saliva and plasma
Time frame: Basal
Measured in pmol/ml
Change in N-oleoylethanolamine (OEA) levels in saliva and plasma
Time frame: Basal
Measured in pmol/ml
Change in N-palmitoylethanolamine (DHEA) levels in saliva and plasma
Time frame: Basal
Measured in pmol/ml
Change in 2-linoleoyl-glycerol (2-LG) levels in saliva and plasma
Time frame: Basal
Measured in pmol/ml
Change in 2-oleoyl-glycerol (2-OG) levels in saliva and plasma
Time frame: Basal
Measured in pmol/ml
31 secondary outcomes
Change in interleukin-1β levels in saliva and plasma
Time frame: Basal
Change in interleukin-6 levels in saliva and plasma
Time frame: Basal
Change in interleukin-8 levels in saliva and plasma
Time frame: Basal
Change in interleukin-10 levels in saliva and plasma
Time frame: Basal
Change in interleukin-17 levels in saliva and plasma
Time frame: Basal
Change in leptin levels in saliva and plasma
Time frame: Basal
Change in vascular endothelial growth factor (VEGF) levels in saliva and plasma
Time frame: Basal
Change in Interferon gamma (IFN)-γ levels in saliva and plasma
Time frame: Basal
Change in Tumor necrosis factor alpha (TNF)-α levels in saliva and plasma
Time frame: Basal
Changes in oral bacteriological profile
Time frame: Basal
Changes in Fasting glucose levels
Time frame: Basal
Changes in insulin levels
Time frame: Basal
Changes from baseline HOMA-IR levels
Time frame: Basal
Changes from baseline HOMA2-IR levels
Time frame: Basal
Changes from baseline HOMA2%S levels
Time frame: Basal
Changes from baseline HOMA2%B levels
Time frame: Basal
Changes from baseline QUICKY levels
Time frame: Basal
Changes from baseline HbA1c levels
Time frame: Basal
BMI (body mass index) changes
Time frame: Basal
Changes in waist circumference
Time frame: Basal
Changes in waist/hip ratio
Time frame: Basal
Changes in waist/height ratio
Time frame: Basal
Changes in blood pressure
Time frame: Basal
Changes in triglycerides
Time frame: Basal
Changes in total cholesterol
Time frame: Basal
Changes in HDL cholesterol
Time frame: Basal
Changes in LDL cholesterol
Time frame: Basal
Changes in sialometry
Time frame: Basal
Changes in salivary viscosity
Time frame: Basal
Changes in salivary pH
Time frame: Basal
Oral health impact profile
Time frame: Basal
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2023.
- BackgroundIDF Diabetes Atlas 10th edition. Accessed September 29, 2022. www.diabetesatlas.org
- BackgroundAleixandre MA, Miguel M. Síndrome metabólico. Endocrinologia y Nutricion. 2007;54(9). doi:10.1016/S1575-0922(07)71487-0
- Background: PubMed 3056758Reaven GM. Banting lecture 1988. Role of insulin resistance in human disease. Diabetes. 1988 Dec;37(12):1595-607. doi: 10.2337/diab.37.12.1595.
- Background: PubMed 23418299Bissett SM, Stone KM, Rapley T, Preshaw PM. An exploratory qualitative interview study about collaboration between medicine and dentistry in relation to diabetes management. BMJ Open. 2013 Feb 14;3(2):e002192. doi: 10.1136/bmjopen-2012-002192. Print 2013.
- Background: PubMed 34059955Tavares RDCR, Ortigara GB, Tatsch KF, Ferreira CM, Boligon J, Moreira CHC. Association between periodontitis and glycated hemoglobin levels in individuals living in rural Southern Brazil. Clin Oral Investig. 2021 Dec;25(12):6901-6907. doi: 10.1007/s00784-021-03980-y. Epub 2021 May 31.
- Background: PubMed 29441048Kriebel K, Hieke C, Muller-Hilke B, Nakata M, Kreikemeyer B. Oral Biofilms from Symbiotic to Pathogenic Interactions and Associated Disease -Connection of Periodontitis and Rheumatic Arthritis by Peptidylarginine Deiminase. Front Microbiol. 2018 Jan 30;9:53. doi: 10.3389/fmicb.2018.00053. eCollection 2018.
- Background: PubMed 7739481Canepari P, Zerman N, Cavalleri G. Lack of correlation between salivary Streptococcus mutans and lactobacilli counts and caries in IDDM children. Minerva Stomatol. 1994 Nov;43(11):501-5.
- Background: PubMed 30596147Estrich CG, Araujo MWB, Lipman RD. Prediabetes and Diabetes Screening in Dental Care Settings: NHANES 2013 to 2016. JDR Clin Trans Res. 2019 Jan;4(1):76-85. doi: 10.1177/2380084418798818. Epub 2018 Sep 6.
- Background: PubMed 30326764Kocher T, Holtfreter B, Petersmann A, Eickholz P, Hoffmann T, Kaner D, Kim TS, Meyle J, Schlagenhauf U, Doering S, Gravemeier M, Prior K, Rathmann W, Harks I, Ehmke B, Koch R. Effect of Periodontal Treatment on HbA1c among Patients with Prediabetes. J Dent Res. 2019 Feb;98(2):171-179. doi: 10.1177/0022034518804185. Epub 2018 Oct 16.
- BackgroundArtur C, Otto-Buczkowska E (2014) Oral Health Problems among Diabetic Patients - Part of Dental Professionals in Diagnostic and Therapy. J Oral Hyg Health 2:167. doi:10.4172/2332-0702.1000167
- Background: PubMed 31434293Di Marzo V, Silvestri C. Lifestyle and Metabolic Syndrome: Contribution of the Endocannabinoidome. Nutrients. 2019 Aug 20;11(8):1956. doi: 10.3390/nu11081956.
- Background: PubMed 26374449Gatta-Cherifi B, Cota D. New insights on the role of the endocannabinoid system in the regulation of energy balance. Int J Obes (Lond). 2016 Feb;40(2):210-9. doi: 10.1038/ijo.2015.179. Epub 2015 Sep 16.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Francisco J Bermúdez-Silva, PhD principal investigator
Hospital Regional Universitario de Málaga - FIMABIS
Questions about this trial
What is this clinical trial studying?
An observational study of PreDiabetes and Diabetes Mellitus, Type 2, run by Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rodolfo M Ortiz Flores, PhD (951 29 03 43 / 951 03 01 17, rodolfo.ortiz@ibima.eu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in 2-arachidonoyl-glycerol (2-AG) levels in saliva and plasma (time frame: Basal). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06040164, which also lists 30 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2023.