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临床试验/CTRI/2025/08/092886
CTRI/2025/08/092886尚未招募不适用

Association between non-Insulin based Insulin resistance indices, Weight-Adjusted Waist index (WWI), systemic inflammation, periodontitis and hypertension- An observational study

Dr Aparna Rajesh1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2025年9月15日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
100
试验地点
1
主要终点
To investigate the association between periodontitis, hypertension and insulin resistance at baseline.

研究概览

简要总结

Periodontitis is a common inflammatory disease caused by a dysbiotic biofilm and affects the soft and hard tissues around teeth. Inflammation is considered an important driver of vascular dysfunction and is implicated in the development and progression of hypertension. Recent evidence suggests a possible causal link between periodontitis and hypertension. In patients with periodontitis, microbial dysbiosis from increased bacteria in periodontal pockets is related to metabolic dysfunction and inflammation-induced Insulin resistance (IR). Hyperinsulinemia closely related to IR activates the renin-angiotensin-aldosterone system, promotes renal sodium retention and ultimately leads to hypertension.

The non-Insulin bases IR indices, including the Triglyceride index (TyG), Triglyceride to high-density lipoprotein cholesterol ratio (TG/HDL-C) and metabolic score for insulin resistance index (METS-IR) have been identified as useful markers for assessing insulin resistance. A significant association is also present between periodontitis and non-Insulin based IR indices. The TyG index is acknowledged as the preferred method for assessing IR in hypertensive individuals; TG/HDL-C ratio and METS-IR are also associated with a higher prevalence of hypertension.

The weight-adjusted waist index (WWI) provides a more detailed evaluation of central obesity compared to traditional measures like body mass index (BMI) & waist circumference (WC). Central obesity, characterized by excess visceral fat, is particularly concerning due to its strong link to metabolic issues and IR. A direct link has also been postulated between WWI and the risk of developing hypertension.

In periodontitis, bacterial components or locally produced pro-inflammatory cytokines may enter the circulation and cause systemic inflammation. Recent evidence implicates oral microorganisms in the nitrate-nitrite-nitric oxide (NO) pathway and the pathogenesis of hypertension. The serum inflammatory biomarkers, high sensitivity C-reactive protein (hs-CRP) and white blood cells (WBCs), can act as a proxy of systemic inflammation associated with both these diseases.

Recent evidence suggests periodontitis, hypertension and IR are closely linked but limited data is available on the nature of the association. Hence in this cross-sectional study we seek to examine the correlation between these diseases & to investigate the role of non-insulin-based IR indices, WWI, and systemic inflammation in otherwise healthy participants with or without generalised periodontitis and hypertension.

研究设计

研究类型
Observational

入排标准

年龄范围
35.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • Patients who have not received any periodontal treatment in previous six months.
  • Patients with a diagnosis of generalized periodontitis as per World Workshop Classification criteria (2017)
  • Patients who are otherwise systemically healthy (no other systemic conditions as per medical history assessment / interview).

排除标准

  • Patients with systemic diseases including diabetes mellitus, hypertension, cardiovascular diseases, rheumatoid arthritis, tumours, autoimmune diseases and renal diseases.
  • Pregnant and lactating females.
  • Any other systemic disease which can alter the course of periodontal disease.
  • Patients on medications including anti-inflammatory drugs, antibiotics and anti-epileptic drugs in the past 6 months.
  • Post-menopausal women.

结局指标

主要结局

To investigate the association between periodontitis, hypertension and insulin resistance at baseline.

时间窗: Baseline

次要结局

  • To investigate the role of non-insulin-based insulin resistance indices, weight-adjusted waist index and systemic inflammation in periodontitis and hypertension at baseline.(Baseline)

研究者

发起方
Dr Aparna Rajesh
申办方类型
Other [Self funded]
责任方
Principal Investigator
主要研究者

Dr Aparna Rajesh

The Oxford Dental College, Bangalore

研究点 (1)

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