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

March 16, 2023 updated by: Norhan Safwat Abd El Naem Salama, Assiut University
The aim is to study the association of H. pylori infection with T2DM and its relation with glycated hemoglobin (HbA1c) levels

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

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].

H. pylori is mainly acquired in childhood by the fecaloral, oral-oral, or gastro-oral route and has been recognized as a worldwide public health problem, which is more prevalent in developing countries [6].

H. pylori infection induces an acute polymorphonuclear 7 infiltration in the gastric mucosa, which is gradually replaced by an immunologically mediated, chronic, predominantly mononuclear cellular infiltration. The mononuclear infiltration is characterized by the local production and systemic diffusion of proinflammatory cytokines that can affect remote tissues and organic [7] As a result, an increased prevalence of extradigestive diseases has been reported in those with evidence of H. pylori infection in recent years, including ischemic heart disease, autoimmune thyroid diseases, sideropenic anemia, idiopathic

thrombocytopenic purpura, neurologic diseases, and hepatobiliary diseases[8]. T2DM is an emerging pandemic, responsible for an estimated 3.8 million adult deaths worldwide [9].

The pathogenesis of T2DM is complex, with risk factors associated with lifestyle (e.g. diet, obesity, and physical activity), genetic background, and socioeconomic factors [10].

In T2DM, the pancreas can no longer produce enough insulin to overcome the cellular loss of sensitivity, resulting in the accumulation of sugar in the bloodstream [11]. Identification of treatable causes of this disease will aid in the development of strategies to delay or prevent its onset or slow its progression. Recent evidence implicates the pathological involvement of inflammation in T2DM, which is an important process induced by H. pylori infection [12]. [13], who reported that the prevalence of H. pylori infection was higher in diabetics (24%) than in controls of similar age, sex, and socioeconomical status after 3 years of follow-up, and the reinfection rate was higher in diabetic patients. [14], who reported that there was no difference in H. pylori prevalence between patient with DM and non-DM controls. [15], who reported that H. pylori infection was positively associated with HbA1c levels through a large-scale cross-sectional analysis, which indicated a role of H. pylori in impaired glucose tolerance in adults.

Study Type

Observational

Enrollment (Anticipated)

146

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 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

Ages Eligible for Study

35 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

cross-sectional study

Description

Inclusion Criteria:

-

Exclusion Criteria:

- 1) 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

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The prevelance of H PYLORI Infection in type 2 DM
Time Frame: 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
11\2022 to11\2023

Collaborators and Investigators

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

Sponsor

Assiut University

Investigators

  • Study Chair: assiut Egypt, hospital, Egypt

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 (Anticipated)

April 1, 2023

Primary Completion (Anticipated)

May 1, 2024

Study Completion (Anticipated)

June 1, 2024

Study Registration Dates

First Submitted

March 16, 2023

First Submitted That Met QC Criteria

March 16, 2023

First Posted (Actual)

March 29, 2023

Study Record Updates

Last Update Posted (Actual)

March 29, 2023

Last Update Submitted That Met QC Criteria

March 16, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H PYLORI Infection

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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Conditions

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