Relation of Helicobacter Pylori in Prediabetic Patients

December 21, 2023 updated by: Khaled mahmmoud Ibrahim, Assiut University

Relation of Helicobacter Pylori Infection in Patients With Impaired Glucose Tolerance and Their Lipid Profile in Upper Egypt

The primary objective of this study is to : find the relation between H.pylori infection and pre-diabetic patients with lipid profile

. Specifically, the study aims to:

  1. affect of H.pylori infection in pre-diabetic patients
  2. realation between Pre-diabetic patient and lipid profile
  3. Risk factor of H.pylori infection in pre-diabetic patients D)HbA1C test measures your average blood sugar level over the past 2 or 3 months.

e)Fasting Blood Sugar Test. f) the IgG antibody of h.pylori.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Pre-diabetic state is aphase of impaired glucose tolerance 2 hours Postprandial Glucose (PG) in 75 g oral glucose tolerance test 140 mg/dL-199 mg/dL and/or impaired fasting glucose 100 mg/dL-125 mg/dL and/or HbA1c 5.7-6.4% [5]. Pre-diabetes is pathophysiologically similar to Type II Diabetes with basic defect being insulin resistance and early beta cell failure. The amplitude of large pulses and the rapid oscillations of insulin secretion are lost in pre-diabetes. In pre-diabetes, the glycaemic excursions are usually lower than normaland there is a delay and prolongation in the second phase of insulin secretion [6]. Recent studies have shown that colonisation with H.pylori is associated with increased development of diabetes mellitus [7-11]. A step towards identifying treatable causes of diabetes mellitus will aid the medical health system in developing new strategies in preventing the progression of pre-diabetes to overt diabetes mellitus .Dyslipidemia is a complex disease and a major risk factor foradverse cardiovascular events [12]. High levels of Low Density Lipoproteins (LDL) and low levels of High Density Lipoprotein (HDL) are associated with increased incidence of stoke and myocardial infarction [13]. dyslipidemia also plays a major role in macrovascular complications of Diabetes [14]. There is increasing evidence for the role of H.pylori infection in the initiation, development or persistence of atherosclerosis and coronary heart disease [15,16]. Therefore, exploring the role of treatable causes of dyslipidemia like H.pylorimay help in preventing the progression of dyslipidemia and its adverse effects.The present study aimed to assess the possible role of H.pylori infection on diabetic profile and lipid profile in pre-diabetic patients.

Study Type

Observational

Enrollment (Estimated)

82

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

  • Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

Descriptive statistics will be used to summarize the demographic and clinical characteristics of the study population, as well as fatigue scores. Bivariate analysis (e.g., t-tests, chi-square tests) will be employed to identify significant associations between demographic, clinical, and psychosocial variables with fatigue severity.

Multiple regression analysis will be performed to determine the independent predictors of hemodialysis-associated fatigue, considering factors with significant associations from the bivariate analysis. Statistical significance will be set at p < 0.05.

Description

Inclusion Criteria:

  • clinical diagnosis ofPre-diabetic patients, age 30-60 years of either gender with fasting glucose 100 mg/dL-125 mg/dL and/or HbA1c 5.7-6.4%

Exclusion Criteria:

  • insulin dependent diabetes
  • hyperlipidemia

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
H.pylori in predibetic with lipid profile
Lipid profile HbA1c
Diagnostic test: HbA1c
Blood glucose in last 3 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Relation of Helicobacter pylori Infection in patients with Impaired glucose tolerance and their lipid profile in upper Egypt.
Time Frame: Baseline
Is there relationship between h.pylori in predibetic patients if they are positive increased to be diabetic
Baseline

Collaborators and Investigators

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

Sponsor

Assiut University

Investigators

  • Study Director: Mohammed Fasil, Prof, Assiut University

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 (Estimated)

March 1, 2024

Primary Completion (Estimated)

March 1, 2025

Study Completion (Estimated)

April 1, 2025

Study Registration Dates

First Submitted

December 10, 2023

First Submitted That Met QC Criteria

December 18, 2023

First Posted (Actual)

December 19, 2023

Study Record Updates

Last Update Posted (Actual)

December 28, 2023

Last Update Submitted That Met QC Criteria

December 21, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Relation of Helicobacter in p

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.

Clinical Trials on H.Pylori Infection

Clinical Trials on HbA1c

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Kyrgyzstan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe