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Role of Helicobacter Pylori in Microalbuminuria

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04216654
Recruitment Status : Completed
First Posted : January 3, 2020
Last Update Posted : January 3, 2020
Sponsor:
Information provided by (Responsible Party):
Hosam Mohammad Ahmad, Minia University

Brief Summary:

The aim of this study is to:

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

Condition or disease Intervention/treatment
Microalbuminuria Due to Type 2 Diabetes Mellitus Diagnostic Test: ELISA (enzyme-linked immunosorbent assay)

Detailed Description:
Helicobacter pylori, previously known as Campylobacter pylori, is a gram-negative, microaerophilic bacterium usually found in the stomach. It was identified in 1982 by Australian scientists Barry Marshall and Robin Warren, who found that it was present in a person with chronic gastritis, gastric ulcers and conditions not previously believed to have a microbial cause. It is also linked to the development of duodenal ulcers and stomach cancer. However, over 80% of individuals infected with the bacterium are asymptomatic, and it may play an important role in the natural stomach ecology. [1] More than 50% of the world's population have H. pylori in their upper gastrointestinal tract. [2] Infection is more common in developing countries than Western countries. [3] H. pylori's helical shape (from which the genus name derives) is thought to have evolved to penetrate the mucoid lining of the stomach. [4, 5] Microalbuminuria, which is defined as an increased urinary albumin to creatinine ratio (UACR) of 30-300 μg/mg .[15] Has been known to be a strong predictor of the development of diabetic nephropathy. [16] It has also been demonstrated that microalbuminuria is a risk factor for cardiovascular disease in the general and diabetic populations. [17-19] and the increased urinary leakage of albumin reflects vascular damage, i.e., endothelial dysfunction or low grade chronic inflammation. [20] In addition, some studies have reported a relationship between microalbuminuria and metabolic syndrome, suggesting that insulin resistance underlies the pathogenesis of microalbuminuria. [21-23]

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Study Type : Observational
Actual Enrollment : 200 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: The Role of Helicobacter Pylori in Microalbuminuria in Type 2 Diabetic Patients
Actual Study Start Date : July 1, 2019
Actual Primary Completion Date : November 1, 2019
Actual Study Completion Date : December 1, 2019

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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)
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(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)
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(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)
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.




Primary Outcome Measures :
  1. association between microalbuminuria and infection by H. pylori in type 2 diabetic patients. [ Time Frame: baseline time ]
    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



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Ages Eligible for Study:   45 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
200 adult Type 2 Diabetic patients
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 1. Those receiving anti-ulcer treatment in the last three months and still receiving proton-pump inhibitors (PPI) or H2 receptor blockers.

    2. Diabetic patients with poor glucose regulation diagnosed previously and detected in laboratory parameters as having diabetic nephropathy.

    3. 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.

    12. 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.

    16. 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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04216654


Locations
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Egypt
Cairo
Cairo, Egypt, 11865
Sponsors and Collaborators
Minia University
Additional Information:
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Responsible Party: Hosam Mohammad Ahmad, Dr., Minia University
ClinicalTrials.gov Identifier: NCT04216654    
Other Study ID Numbers: H.pylori and microalbuminuria
First Posted: January 3, 2020    Key Record Dates
Last Update Posted: January 3, 2020
Last Verified: December 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases