Role of Helicobacter Pylori in Microalbuminuria

NCT04216654 | Completed

• 1 other identifier: H.pylori and microalbuminuria
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to:

1. 1.Investigate a possible association between microalbuminuria and infection by H. pylori in type 2 diabetic patients.
2. 2.Investigate the effect of previous and active infection of H. pylori on microalbuminuria in type 2 diabetic patients.

Conditions

Microalbuminuria Due to Type 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• association between microalbuminuria and infection by H. pylori in type 2 diabetic patients.

  Measure the urinary albumin to creatinine ratio (UACR) to estimate the presence of Microalbuminuria in type 2 diabetic patients among H. pylori-infected, old infected and non infected patients

  baseline time

Study Arms (3)

Group(A)

52 cases of type 2 diabetic patients.They have +ve Serum antibody and Stool antigen specific for Helicobacter pylori.

Diagnostic Test: ELISA (enzyme-linked immunosorbent assay)

Group(B)

36 cases of type 2 diabetic patients. They have +ve Serum antibody and -ve Stool antigen-specific for Helicobacter pylori.

Diagnostic Test: ELISA (enzyme-linked immunosorbent assay)

Group(C)

112 cases of type 2 diabetic patients. They have -ve Serum antibody and Stool antigen-specific for Helicobacter pylori.

Diagnostic Test: ELISA (enzyme-linked immunosorbent assay)

Interventions

ELISA (enzyme-linked immunosorbent assay) DIAGNOSTIC_TEST

ELISA Principle. Enzyme-linked Immunosorbent Assays (ELISAs) combine the specificity of antibodies with the sensitivity of simple enzyme assays, by using antibodies or antigens coupled to an easily-assayed enzyme. ELISAs can provide a useful measurement of antigen or antibody concentration.

Group(A); Group(B); Group(C)

Eligibility Criteria

• Age: 45 Years - 64 Years
• Sex: all
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

200 adult Type 2 Diabetic patients

You may qualify if:

• Age \>45 years and absence of any sever illness.

You may not qualify if:

• \. Those receiving anti-ulcer treatment in the last three months and still receiving proton-pump inhibitors (PPI) or H2 receptor blockers.
• \. Diabetic patients with poor glucose regulation diagnosed previously and detected in laboratory parameters as having diabetic nephropathy.
• \. Those have diabetic retinopathy, neuropathy. 4. Those have renal impairment or known to have renal disease. 5. Those have any primary kidney disease. 6. Those have any systemic disease that my affect the kidney. 7. Those have lupus erythematosus, rheumatoid or other immunological disease. 8. Those have any chronic illness that may affect the kidney 9. Those have urinary tract infections or renal stones. 10. Those may have proteinuria due to any other cause. 11. Heavy exercise, excessive protein ingestion, fluid overload, increase the urinary protein excretion discarded from the study.
• \. Those have chronic liver disease. 13. Those have heart failure. 14. Hypertensive patients. 15. Diabetics having \>120 mmHg systolic blood pressure and \>85 mmHg diastolic blood pressure.
• \. Those have malignancy. 17. Those with inflammatory disease, those obliged to continue antibiotic treatment for various reasons 18. Smokers 19. Those not providing consent for the study

Sponsors & Collaborators

• Minia University: lead

Study Sites (1)

Cairo

Cairo, 11865, Egypt

Location

Related Links

• book
• pdf file

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: December 31, 2019
• First Posted: January 3, 2020
• Study Start: July 1, 2019
• Primary Completion: November 1, 2019
• Study Completion: December 1, 2019
• Last Updated: January 3, 2020

Record last verified: 2019-12

Locations

EG (1)