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

NCT05789550 | Unknown

• 1 other identifier: H PYLORI Infection
• Study Type: observational
• Target: 146
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

H Pylori Infection

Outcome Measures

Primary Outcomes (1)

• The prevelance of H PYLORI Infection in type 2 DM

  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

Interventions

ALL PATIENT DIABETIC IN THIS PERIOD WILL BE INCLUDED IN THE STUDY DIAGNOSTIC_TEST

1. Full clinical history with detailed history about T2DM (its duration and treatment). 2. Full medical examination, including BMI using the formula: weight (kg)/height (m2). 3. Laboratory investigation, including the following: 1. Complete blood picture. 2. Fasting blood sugar (FBS). 3. Postprandial blood sugar (PP-BS) (2 h after 75 g glucose orally). 4. HbA1c. 5. Kidney function tests (serum creatinine and blood urea). 6. Liver function tests (serum albumin, ALT, and AST). 7. Lipid profile, which include cholesterol and triglyceride. 4)H PYLORI Ag IN Stool

Eligibility Criteria

• Age: 35 Years - 75 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

cross-sectional study

You may not qualify if:

• \- 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

Sponsors & Collaborators

• Assiut University: lead

Related Publications (10)

• Draz U, Rathore R, Butt NF, Randhawa FA, Malik U, Waseem T. Presence of pre-diabetes in Helicobacter pylori positive versus Helicobacter pylori negative patients having dyspepsia. J Pak Med Assoc. 2018 Jun;68(6):939-941.

  PMID: 30323363 BACKGROUND

• Haj S, Chodick G, Refaeli R, Goren S, Shalev V, Muhsen K. Associations of Helicobacter pylori infection and peptic disease with diabetic mellitus: Results from a large population-based study. PLoS One. 2017 Aug 29;12(8):e0183687. doi: 10.1371/journal.pone.0183687. eCollection 2017.

  PMID: 28850590 BACKGROUND

• He C, Yang Z, Lu NH. Helicobacter pylori infection and diabetes: is it a myth or fact? World J Gastroenterol. 2014 Apr 28;20(16):4607-17. doi: 10.3748/wjg.v20.i16.4607.

  PMID: 24782613 BACKGROUND

• Outlioua A, Badre W, Desterke C, Echarki Z, El Hammani N, Rabhi M, Riyad M, Karkouri M, Arnoult D, Khalil A, Akarid K. Gastric IL-1beta, IL-8, and IL-17A expression in Moroccan patients infected with Helicobacter pylori may be a predictive signature of severe pathological stages. Cytokine. 2020 Feb;126:154893. doi: 10.1016/j.cyto.2019.154893. Epub 2019 Dec 24.

  PMID: 31877554 BACKGROUND

• Malaty HM. Epidemiology of Helicobacter pylori infection. Best Pract Res Clin Gastroenterol. 2007;21(2):205-14. doi: 10.1016/j.bpg.2006.10.005.

  PMID: 17382273 BACKGROUND

• Eskandarian R, Ghorbani R, Shiyasi M, Momeni B, Hajifathalian K, Madani M. Prognostic role of Helicobacter pylori infection in acute coronary syndrome: a prospective cohort study. Cardiovasc J Afr. 2012 Apr;23(3):131-5. doi: 10.5830/CVJA-2011-016.

  PMID: 22555636 BACKGROUND

• Mishra RR, Tewari M, Shukla HS. Association of Helicobacter pylori infection with inflammatory cytokine expression in patients with gallbladder cancer. Indian J Gastroenterol. 2013 Jul;32(4):232-5. doi: 10.1007/s12664-013-0321-6. Epub 2013 Feb 28.

  PMID: 23446740 BACKGROUND

• van Dieren S, Beulens JW, van der Schouw YT, Grobbee DE, Neal B. The global burden of diabetes and its complications: an emerging pandemic. Eur J Cardiovasc Prev Rehabil. 2010 May;17 Suppl 1:S3-8. doi: 10.1097/01.hjr.0000368191.86614.5a.

  PMID: 20489418 BACKGROUND

• Agardh E, Allebeck P, Hallqvist J, Moradi T, Sidorchuk A. Type 2 diabetes incidence and socio-economic position: a systematic review and meta-analysis. Int J Epidemiol. 2011 Jun;40(3):804-18. doi: 10.1093/ije/dyr029. Epub 2011 Feb 19.

  PMID: 21335614 BACKGROUND

• Papamichael KX, Papaioannou G, Karga H, Roussos A, Mantzaris GJ. Helicobacter pylori infection and endocrine disorders: is there a link? World J Gastroenterol. 2009 Jun 14;15(22):2701-7. doi: 10.3748/wjg.15.2701.

  PMID: 19522019 BACKGROUND

Study Officials

• assiut Egypt, hospital

  Egypt

  STUDY CHAIR

Central Study Contacts

Norhan safwat abd elnaem, resident

CONTACT

01115685727; Safwatnorhan748@gamil.com

mona Mohamed Soliman, prof

CONTACT

01005210950; monasoliman@aun.edu.eg

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: doctor

Study Record Dates

• First Submitted: March 16, 2023
• First Posted: March 29, 2023
• Study Start: April 1, 2023
• Primary Completion: May 1, 2024
• Study Completion: June 1, 2024
• Last Updated: March 29, 2023

Record last verified: 2023-03