NCT07302022

Brief Summary

The aim of this research is to assess the relationship between metabolic syndrome and gastroesophageal reflux disease (GERD). seeking to determine how components of metabolic syndrome contribute to the risk and severity of GERD.

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
13mo left

Started Dec 2025

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress35%
Dec 2025Sep 2027

First Submitted

Initial submission to the registry

September 26, 2025

Completed
3 months until next milestone

First Posted

Study publicly available on registry

December 24, 2025

Completed
6 days until next milestone

Study Start

First participant enrolled

December 30, 2025

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2026

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2027

Last Updated

December 24, 2025

Status Verified

September 1, 2025

Enrollment Period

8 months

First QC Date

September 26, 2025

Last Update Submit

December 11, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • the prevalence and severity of GERD among patients with metabolic syndrome, as determined by endoscopic assesment

    .endoscopic findings los angles criteria Grade A : one or more mucosal breaks not more than 5mm Grade b: one or more mucosal breaks more than 5mm Grade c : one or more mucosal breaks extending between tops of two mucosal folds but involving less than 75% of esophageal circumference Grade D : one or more mucosal breaks involving 75% of oesophageal circumference

    1 year

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Community sample

You may qualify if:

  • \- 2.3.1-Type of the study: This study will be designed as an observational, cross-sectional, analytical study.
  • StudySetting: This study will be performed at internal medicine, Assuit University Hospitals
  • Studysubjects:
  • Adult patients aged 18 years and above.
  • Patients diagnosed with metabolic syndrome based on standard criteria (e.g., NCEP ATP III).
  • Patients who will undergo upper gastrointestinal (GI) evaluation for GERD symptoms.

You may not qualify if:

  • Patients with a history of upper GI surgery.
  • Pregnant or lactating women.
  • Patients with known malignancy or severe comorbid illness.
  • Patients currently taking proton pump inhibitors (PPIs) or other acid-suppressive therapy.
  • Unwilling or unable to provide informed consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assiut university hospitals

Asyut, Asyut Governorate, Egypt

Location

MeSH Terms

Conditions

Metabolic Syndrome

Condition Hierarchy (Ancestors)

Insulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Central Study Contacts

MOSTAFA Hatem Zedan, Resident

CONTACT

Lecturer of internal medicine at Assiut university hospital

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident

Study Record Dates

First Submitted

September 26, 2025

First Posted

December 24, 2025

Study Start

December 30, 2025

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

September 1, 2027

Last Updated

December 24, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations