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临床试验/NCT05789550
NCT05789550尚未招募不适用

HELICOBACTER PYLORI INFECTION IN TYPE 2 DIABETES MELLITUS IN ASSIUT UNIVERSITY HOSPITAL

Assiut University0 个研究点目标入组 146 人开始时间: 2023年4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
入组人数
146
主要终点
The prevelance of H PYLORI Infection in type 2 DM

研究概览

简要总结

The aim is to study the association of H. pylori infection with T2DM and its relation with glycated hemoglobin (HbA1c) levels

详细描述

Dyspepsia is a worldwide problem that affects 40% of adults. Approximately 10% of all patients presenting for endoscopy for gastrointestinal symptoms have dyspepsia [1] Helicobacter pylori is a gram-negative spiral flagellate bacillus, which normally is a resident of gastric epithelium, It can cause inflammatory cell infiltration in gastric mucosa that produces cytokines, which are not only responsible for local effects but can damage remote tissues causing extradigestive diseases like ischemic heart disease, autoimmune thyroid disease, iron deficiency anemia, idiopathic thrombocytopenic purpura, and neurologic diseases [1].

In addition to this, it is also thought to play a direct or indirect role in the pathogenesis of metabolic syndrome, non-alcoholic fatty liver disease, and type 2 diabetes [2].

Diabetes mellitus (DM) is a major public health problem, with increasing prevalence globally. The major burden (90-95%) is caused by type 2 diabetes mellitus (T2DM), which typically develops in adulthood and is characterized by variable levels of insulin resistance, impaired insulin secretion, and increased glucose production [3].

The association between DM and H. pylori infection remains controversial, although many studies have been done, which concluded that a definiterelationship exists between the two. It is hypothesized that H. pylori infection promotes atherosclerosis by altering lipid metabolism, and this leads to the metabolic syndrome, insulin resistance, and finally, to type 2 diabetes [2].

There are several lines of evidence to implicate increased susceptibility to H. pylori infection in diabetic patients. First, a diabetes-induced impairment of cellular and humoral immunity may enhance an individual's sensitivity to H. pylori infection. Second, diabetes-induced reduction of gastrointestinal motility and acid secretion may promote pathogen colonization and infection rate in the gut. Third, altered glucose metabolism may produce chemical changes in the gastric mucosa that promote H. pylori colonization [4] pylori is a gram-negative, spiral-shaped pathogenic bacterium that specifically colonizes the gastric epithelium causing chronic gastritis, peptic ulcer disease, and/or gastric malignancy [5].

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

年龄范围
35 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • Patients with T1DM. (2) Patients with age less than 35 years. (3) Patients with history of NSAIDs or alcohol intake. (4) Patients already on steroid or immunosuppressive. (5) Patients on proton pump inhibitors. (6) Patients with history of H. pylori-eradication therapy in the previous 6 months.
  • (7) Patients with diagnosed malignancy in previous medical records. (8) Patients with history of hematemesis. (9) Patients with severe weight loss

结局指标

主要结局

The prevelance of H PYLORI Infection in type 2 DM

时间窗: 11\2022 to11\2023

The aim is to study the association of H. pylori infection with T2DM and its relation with glycated hemoglobin (HbA1c) levels

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Norhan Safwat Abd El Naem Salama

doctor

Assiut University

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