H.Pylori InfectionNCT06176547
Relation of Helicobacter Pylori in Prediabetic Patients
An observational study of H.Pylori Infection, run by Assiut University.
Trial summary
The primary objective of this study is to : find the relation between H.pylori infection and pre-diabetic patients with lipid profile . Specifically, the study aims to: 1. affect of H.pylori infection in pre-diabetic patients 2. realation between Pre-diabetic patient and lipid profile 3. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- H.Pylori Infection
- What is being tested?
- HbA1c
- How many people
- 82 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2024to 1 Apr 2025
- 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 18 to 60 years
- All sexes
- Adult
Study population: Descriptive statistics will be used to summarize the demographic and clinical characteristics of the study population, as well as fatigue scores. Bivariate analysis (e.g., t-tests, chi-square tests) will be employed to identify significant associations between demographic, clinical, and psychosocial variables with fatigue severity. Multiple regression analysis will be performed to determine the independent predictors of hemodialysis-associated fatigue, considering factors with significant associations from the bivariate analysis. Statistical significance will be set at p < 0.05.
Who may be able to join
- clinical diagnosis ofPre-diabetic patients, age 30-60 years of either gender with fasting glucose 100 mg/dL-125 mg/dL and/or HbA1c 5.7-6.4%
Who cannot join
- insulin dependent diabetes
- hyperlipidemia
Trial locations and contacts
No sites are listed yet.
Abdalla Esmail, Prof contact
About this study
Official title: Relation of Helicobacter Pylori Infection in Patients With Impaired Glucose Tolerance and Their Lipid Profile in Upper Egypt
The primary objective of this study is to : find the relation between H.pylori infection and pre-diabetic patients with lipid profile
. Specifically, the study aims to:
- affect of H.pylori infection in pre-diabetic patients
- realation between Pre-diabetic patient and lipid profile
- Risk factor of H.pylori infection in pre-diabetic patients D)HbA1C test measures your average blood sugar level over the past 2 or 3 months. e)Fasting Blood Sugar Test. f) the IgG antibody of h.pylori.
Read the detailed description
Pre-diabetic state is aphase of impaired glucose tolerance 2 hours Postprandial Glucose (PG) in 75 g oral glucose tolerance test 140 mg/dL-199 mg/dL and/or impaired fasting glucose 100 mg/dL-125 mg/dL and/or HbA1c 5.7-6.4% [5]. Pre-diabetes is pathophysiologically similar to Type II Diabetes with basic defect being insulin resistance and early beta cell failure. The amplitude of large pulses and the rapid oscillations of insulin secretion are lost in pre-diabetes. In pre-diabetes, the glycaemic excursions are usually lower than normaland there is a delay and prolongation in the second phase of insulin secretion [6]. Recent studies have shown that colonisation with H.pylori is associated with increased development of diabetes mellitus [7-11]. A step towards identifying treatable causes of diabetes mellitus will aid the medical health system in developing new strategies in preventing the progression of pre-diabetes to overt diabetes mellitus .Dyslipidemia is a complex disease and a major risk factor foradverse cardiovascular events [12]. High levels of Low Density Lipoproteins (LDL) and low levels of High Density Lipoprotein (HDL) are associated with increased incidence of stoke and myocardial infarction [13]. dyslipidemia also plays a major role in macrovascular complications of Diabetes [14]. There is increasing evidence for the role of H.pylori infection in the initiation, development or persistence of atherosclerosis and coronary heart disease [15,16]. Therefore, exploring the role of treatable causes of dyslipidemia like H.pylorimay help in preventing the progression of dyslipidemia and its adverse effects.The present study aimed to assess the possible role of H.pylori infection on diabetic profile and lipid profile in pre-diabetic patients.
- Conditions
- H.Pylori Infection
- Being tested
- HbA1c
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HbA1cDiagnostic test
Blood glucose in last 3 months
| Study group | Role | What they receive |
|---|---|---|
| H.pylori in predibetic with lipid profile | Lipid profile HbA1c Receives: Diagnostic Test: HbA1c |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relation of Helicobacter pylori Infection in patients with Impaired glucose tolerance and their lipid profile in upper Egypt.
Is there relationship between h.pylori in predibetic patients if they are positive increased to be diabetic
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2023
- Study start1 Mar 2024 (estimated)
- Primary completion1 Mar 2025 (estimated)
- Study completion1 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for H.Pylori InfectionStudies of the same condition, open and under way.
- More trials run by Assiut 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 82 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Khaled mahmmoud Ibrahim, Assiut University
- Investigators
- Mohammed Fasil, Prof, Study director, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06176547
- Sponsor's protocol ID
- Relation of Helicobacter in p
- Status last verified
- Dec 2023
- First submitted
- 10 Dec 2023
- Last updated
- 28 Dec 2023
- Results posted
- No
Publications
American Diabetes Association: clinical practice recommendations 1996. Diabetes Care. 1996 Jan;19 Suppl 1:S1-118. No abstract available.
PubMed 8689936
Study at a glance
From the registry record, last updated by the sponsor on 28 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relation of Helicobacter Pylori Infection in Patients With Impaired Glucose Tolerance and Their Lipid Profile in Upper Egypt
- ClinicalTrials.gov ID
- NCT06176547
- Acronym / sponsor ID
- Relation of Helicobacter in p
- Conditions
- H.Pylori Infection
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 82 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Mar 2024 (estimated)
- Primary completion
- 1 Mar 2025 (estimated)
- Study completion
- 1 Apr 2025 (estimated)
- First posted
- 19 Dec 2023 (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 primary objective of this study is to : find the relation between H.pylori infection and pre-diabetic patients with lipid profile
. Specifically, the study aims to:
- affect of H.pylori infection in pre-diabetic patients
- realation between Pre-diabetic patient and lipid profile
- Risk factor of H.pylori infection in pre-diabetic patients D)HbA1C test measures your average blood sugar level over the past 2 or 3 months. e)Fasting Blood Sugar Test. f) the IgG antibody of h.pylori.
Detailed description
Pre-diabetic state is aphase of impaired glucose tolerance 2 hours Postprandial Glucose (PG) in 75 g oral glucose tolerance test 140 mg/dL-199 mg/dL and/or impaired fasting glucose 100 mg/dL-125 mg/dL and/or HbA1c 5.7-6.4% [5]. Pre-diabetes is pathophysiologically similar to Type II Diabetes with basic defect being insulin resistance and early beta cell failure. The amplitude of large pulses and the rapid oscillations of insulin secretion are lost in pre-diabetes. In pre-diabetes, the glycaemic excursions are usually lower than normaland there is a delay and prolongation in the second phase of insulin secretion [6]. Recent studies have shown that colonisation with H.pylori is associated with increased development of diabetes mellitus [7-11]. A step towards identifying treatable causes of diabetes mellitus will aid the medical health system in developing new strategies in preventing the progression of pre-diabetes to overt diabetes mellitus .Dyslipidemia is a complex disease and a major risk factor foradverse cardiovascular events [12]. High levels of Low Density Lipoproteins (LDL) and low levels of High Density Lipoprotein (HDL) are associated with increased incidence of stoke and myocardial infarction [13]. dyslipidemia also plays a major role in macrovascular complications of Diabetes [14]. There is increasing evidence for the role of H.pylori infection in the initiation, development or persistence of atherosclerosis and coronary heart disease [15,16]. Therefore, exploring the role of treatable causes of dyslipidemia like H.pylorimay help in preventing the progression of dyslipidemia and its adverse effects.The present study aimed to assess the possible role of H.pylori infection on diabetic profile and lipid profile in pre-diabetic patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| H.pylori in predibetic with lipid profile | – | Diagnostic Test: HbA1cLipid profile HbA1c |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Age groups
- Adult
- Study population
- Descriptive statistics will be used to summarize the demographic and clinical characteristics of the study population, as well as fatigue scores. Bivariate analysis (e.g., t-tests, chi-square tests) will be employed to identify significant associations between demographic, clinical, and psychosocial variables with fatigue severity. Multiple regression analysis will be performed to determine the independent predictors of hemodialysis-associated fatigue, considering factors with significant associations from the bivariate analysis. Statistical significance will be set at p < 0.05.
Key inclusion criteria (1 listed)
- clinical diagnosis ofPre-diabetic patients, age 30-60 years of either gender with fasting glucose 100 mg/dL-125 mg/dL and/or HbA1c 5.7-6.4%
Key exclusion criteria (2 listed)
- insulin dependent diabetes
- hyperlipidemia
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 |
|---|---|---|
| HbA1cBlood glucose in last 3 months | Diagnostic test | H.pylori in predibetic with lipid profile |
Primary outcome
Relation of Helicobacter pylori Infection in patients with Impaired glucose tolerance and their lipid profile in upper Egypt.
Time frame: Baseline
Is there relationship between h.pylori in predibetic patients if they are positive increased to be diabetic
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Dec 2023.
- Background: PubMed 8689936American Diabetes Association: clinical practice recommendations 1996. Diabetes Care. 1996 Jan;19 Suppl 1:S1-118. No abstract available.
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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.
Abdalla Esmail, Prof contact
Mohammed Fasil, Prof study director
Assiut University
Questions about this trial
What is this clinical trial studying?
An observational study of H.Pylori Infection, run by Assiut University.
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 2 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: status not confirmed, as of the sponsor's last update on 28 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Khalid Mahmmoud (01221844481, k.mahmmoud22@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Relation of Helicobacter pylori Infection in patients with Impaired glucose tolerance and their lipid profile in upper Egypt. (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06176547, which also lists 1 linked publication.
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 28 Dec 2023.