Microalbuminuria Due to Type 2 Diabetes MellitusNCT04216654
Role of Helicobacter Pylori in Microalbuminuria
An observational study of Microalbuminuria Due to Type 2 Diabetes Mellitus, run by Minia University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 to 64 years
- Conditions the study is for
- Microalbuminuria Due to Type 2 Diabetes Mellitus
- What is being tested?
- ELISA (enzyme-linked immunosorbent assay)
- How many people
- 200 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jul 2019to 1 Dec 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 64 years
- All sexes
- Adult
Study population: 200 adult Type 2 Diabetic patients
Who may be able to join
- Age >45 years and absence of any sever illness.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Role of Helicobacter Pylori in Microalbuminuria in Type 2 Diabetic Patients
The aim of this study is to:
- Investigate a possible association between microalbuminuria and infection by H. pylori in type 2 diabetic patients.
- Investigate the effect of previous and active infection of H. pylori on microalbuminuria in type 2 diabetic patients.
Read the 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]
- Being tested
- ELISA (enzyme-linked immunosorbent assay)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Group(A) | 52 cases of type 2 diabetic patients.They have +ve Serum antibody and Stool antigen specific for Helicobacter pylori. Receives: 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. Receives: 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. Receives: Diagnostic Test: ELISA (enzyme-linked immunosorbent assay) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: baseline time
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2020
- Study start1 Jul 2019
- Primary completion1 Nov 2019
- Study completion1 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Microalbuminuria Due to Type 2 Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by Minia UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Minia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hosam Mohammad Ahmad, Minia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04216654
- Sponsor's protocol ID
- H.pylori and microalbuminuria
- Status last verified
- Dec 2019
- First submitted
- 31 Dec 2019
- Last updated
- 3 Jan 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Helicobacter Pylori in Microalbuminuria in Type 2 Diabetic Patients
- ClinicalTrials.gov ID
- NCT04216654
- Acronym / sponsor ID
- H.pylori and microalbuminuria
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Minia UniversityUniversity, hospital or other
- Study start
- 1 Jul 2019 (actual)
- Primary completion
- 1 Nov 2019 (actual)
- Study completion
- 1 Dec 2019 (actual)
- First posted
- 3 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to:
- Investigate a possible association between microalbuminuria and infection by H. pylori in type 2 diabetic patients.
- 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]
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group(A) | – | Diagnostic Test: ELISA (enzyme-linked immunosorbent assay)52 cases of type 2 diabetic patients.They have +ve Serum antibody and Stool antigen specific for Helicobacter pylori. |
| Group(B) | – | Diagnostic Test: ELISA (enzyme-linked immunosorbent assay)36 cases of type 2 diabetic patients. They have +ve Serum antibody and -ve Stool antigen-specific for Helicobacter pylori. |
| Group(C) | – | Diagnostic Test: ELISA (enzyme-linked immunosorbent assay)112 cases of type 2 diabetic patients. They have -ve Serum antibody and Stool antigen-specific for Helicobacter pylori. |
Who may qualify
- Ages
- 45 to 64 years
- Sex
- All
- Age groups
- Adult
- Study population
- 200 adult Type 2 Diabetic patients
Key inclusion criteria (1 listed)
- Age >45 years and absence of any sever illness.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Diagnostic test | Group(A), Group(B), Group(C) |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2020.
- bookLink provided by the sponsor.
- pdf fileLink provided by the sponsor.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Microalbuminuria Due to Type 2 Diabetes Mellitus, run by Minia University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
association between microalbuminuria and infection by H. pylori in type 2 diabetic patients. (time frame: baseline time). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jan 2020.