NCT06176547

Brief 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. 1.affect of H.pylori infection in pre-diabetic patients
  2. 2.realation between Pre-diabetic patient and lipid profile
  3. 3.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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
82

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2024

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 10, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

December 19, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

March 1, 2024

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2025

Completed
Last Updated

December 28, 2023

Status Verified

December 1, 2023

Enrollment Period

1 year

First QC Date

December 10, 2023

Last Update Submit

December 21, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

    Baseline

Study Arms (1)

H.pylori in predibetic with lipid profile

Lipid profile HbA1c

Diagnostic Test: HbA1c

Interventions

HbA1cDIAGNOSTIC_TEST

Blood glucose in last 3 months

H.pylori in predibetic with lipid profile

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • 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%

You may not qualify if:

  • insulin dependent diabetes
  • hyperlipidemia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • American Diabetes Association: clinical practice recommendations 1996. Diabetes Care. 1996 Jan;19 Suppl 1:S1-118. No abstract available.

    PMID: 8689936BACKGROUND

Study Officials

  • Mohammed Fasil, Prof

    Assiut University

    STUDY DIRECTOR

Central Study Contacts

Khalid Mahmmoud

CONTACT

Abdalla Esmail, Prof

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

December 10, 2023

First Posted

December 19, 2023

Study Start

March 1, 2024

Primary Completion

March 1, 2025

Study Completion

April 1, 2025

Last Updated

December 28, 2023

Record last verified: 2023-12