Relation of Helicobacter Pylori in Prediabetic Patients

H.Pylori Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06176547
• Other study ID #: Relation of Helicobacter in p
• Status: Not yet recruiting
• Start date: March 1, 2024
• Est. completion date: April 1, 2025

Study information

• Verified date: December 2023
• Source: Assiut University
• Contact: Khalid Mahmmoud
• Phone: 01221844481
• Email: k.mahmmoud22[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 82
• Est. completion date: April 1, 2025
• Est. primary completion date: March 1, 2025
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• H.Pylori Infection
• Infections

Intervention

Diagnostic Test:
• HbA1c
Blood glucose in last 3 months

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

References & Publications (1)

American Diabetes Association: clinical practice recommendations 1996. Diabetes Care. 1996 Jan;19 Suppl 1:S1-118. No abstract available. — View Citation

Outcome

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