NCT02888808

Brief Summary

Obesity is a strong risk factor for GERD. This study assessed the role of obesity among patients having erosive GERD and controls.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
160

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2013

Typical duration for all trials

Status
completed

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

Study Start

First participant enrolled

March 1, 2013

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

August 12, 2016

Completed
24 days until next milestone

First Posted

Study publicly available on registry

September 5, 2016

Completed
Last Updated

September 5, 2016

Status Verified

August 1, 2016

Enrollment Period

2.8 years

First QC Date

August 12, 2016

Last Update Submit

August 30, 2016

Conditions

Gastro-esophageal Reflux Disease With Ulceration.

Keywords

gastroesophageal reflux diseasewomenNigeriaobesity

Outcome Measures

Primary Outcomes (1)

  • Obesity associated with GERD

    Measurement of anthropometric indices

    Immediate.

Secondary Outcomes (3)

  • Body mass index is associated with GERD

    Immediate

  • Waist circumference is associated with GERD

    Immediate

  • Waist hip ratio is associated with GERD

    Immediate

Study Arms (2)

Erosive GERD

Gastroscopy examination.

Other: Gastroscopy

Control population

Gastroscopy examination.

Other: Gastroscopy

Interventions

GastroscopyOTHER

Upper gastrointestinal endoscopy procedure

Control populationErosive GERD

Eligibility Criteria

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

Nigerians with dyspeptic symptoms

You may qualify if:

  • Patients with dyspepsia

You may not qualify if:

  • Patients that refused consent.
  • Patients with gastric cancer
  • Patients with gastric outlet obstruction
  • Pregnant women
  • Active gastrointestinal bleeding
  • Cigarette smokers
  • Patients on Naso-gastric tube.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Gastroesophageal RefluxObesity

Interventions

Gastroscopy

Condition Hierarchy (Ancestors)

Esophageal Motility DisordersDeglutition DisordersEsophageal DiseasesGastrointestinal DiseasesDigestive System DiseasesOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Endoscopy, GastrointestinalEndoscopy, Digestive SystemDiagnostic Techniques, Digestive SystemDiagnostic Techniques and ProceduresDiagnosisEndoscopyDiagnostic Techniques, SurgicalDigestive System Surgical ProceduresSurgical Procedures, OperativeMinimally Invasive Surgical Procedures

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

August 12, 2016

First Posted

September 5, 2016

Study Start

March 1, 2013

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

September 5, 2016

Record last verified: 2016-08

Data Sharing

IPD Sharing
Will not share