NCT04216654

Role of Helicobacter Pylori in Microalbuminuria

The Role of Helicobacter Pylori in Microalbuminuria in Type 2 Diabetic Patients

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 200 (actual)
• Sponsor: Minia University · Academic / Other
• Sex: All
• Age: 45 Years – 64 Years
• Healthy volunteers: —

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.

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. \[21-23\]

Conditions

• Microalbuminuria Due to Type 2 Diabetes Mellitus

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2019-07-01
• Primary completion: 2019-11-01
• Completion: 2019-12-01
• First posted: 2020-01-03
• Last updated: 2020-01-03

Locations

1 site across 1 country: Egypt