跳至主要内容
临床试验/NCT06040164
NCT06040164尚未招募不适用

Molecular Study of Oral Dysbacteriosis in People With Prediabetes and Diabetes

Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud0 个研究点目标入组 60 人开始时间: 2023年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
60
主要终点
Change in N-oleoylethanolamine (OEA) levels in saliva and plasma

研究概览

简要总结

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

详细描述

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.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Cross Sectional

入排标准

年龄范围
40 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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
  • Participants who have not followed the specifications prior to sampling
  • Participants who did not sign the informed consent

结局指标

主要结局

Change in N-oleoylethanolamine (OEA) levels in saliva and plasma

时间窗: Basal

Measured in pmol/ml

Change in 2-linoleoyl-glycerol (2-LG) levels in saliva and plasma

时间窗: Basal

Measured in pmol/ml

Change in N-palmitoylethanolamine (DHEA) levels in saliva and plasma

时间窗: Basal

Measured in pmol/ml

Change in N-palmitoylethanolamine (PEA) levels in saliva and plasma

时间窗: Basal

Measured in pmol/ml

Change in 2-arachidonoyl-glycerol (2-AG) levels in saliva and plasma

时间窗: Basal

Measured in pmol/ml

Change in N-arachidonoylethanolamine (AEA) levels in saliva and plasma

时间窗: Basal

Measured in pmol/ml

Change in 2-oleoyl-glycerol (2-OG) levels in saliva and plasma

时间窗: Basal

Measured in pmol/ml

次要结局

  • Changes in oral bacteriological profile(Basal)
  • Changes from baseline HOMA2-IR levels(Basal)
  • Changes from baseline HOMA2%S levels(Basal)
  • Changes in sialometry(Basal)
  • Change in leptin levels in saliva and plasma(Basal)
  • Change in vascular endothelial growth factor (VEGF) levels in saliva and plasma(Basal)
  • Changes in blood pressure(Basal)
  • Oral health impact profile(Basal)
  • Change in interleukin-8 levels in saliva and plasma(Basal)
  • Change in interleukin-10 levels in saliva and plasma(Basal)
  • Change in interleukin-17 levels in saliva and plasma(Basal)
  • Change in Interferon gamma (IFN)-γ levels in saliva and plasma(Basal)
  • Changes from baseline QUICKY levels(Basal)
  • Change in interleukin-1β levels in saliva and plasma(Basal)
  • Changes in Fasting glucose levels(Basal)
  • BMI (body mass index) changes(Basal)
  • Changes in waist/height ratio(Basal)
  • Changes in triglycerides(Basal)
  • Changes in HDL cholesterol(Basal)
  • Change in interleukin-6 levels in saliva and plasma(Basal)
  • Change in Tumor necrosis factor alpha (TNF)-α levels in saliva and plasma(Basal)
  • Changes in insulin levels(Basal)
  • Changes from baseline HOMA-IR levels(Basal)
  • Changes from baseline HOMA2%B levels(Basal)
  • Changes from baseline HbA1c levels(Basal)
  • Changes in waist circumference(Basal)
  • Changes in total cholesterol(Basal)
  • Changes in LDL cholesterol(Basal)
  • Changes in waist/hip ratio(Basal)
  • Changes in salivary viscosity(Basal)
  • Changes in salivary pH(Basal)

研究者

发起方
Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud
申办方类型
Other
责任方
Sponsor

相似试验