Relationship of Obesity With GERD Among Nigerians | NCT02888808

Studies
Relationship of Obesity With GERD Among Nigerians

NCT02888808

Sponsor

Obafemi Awolowo University Teaching Hospital

Status

Completed

Last Update Posted

Sep 5, 2016Estimated

Enrollment

160Actual

Phase

Not provided

Conditions

Gastro-esophageal Reflux Disease With Ulceration.

Interventions

Gastroscopy

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2013

Primary Completion Date

Dec 2015Actual

Completion Date

Dec 2015Actual

First Submitted Date

Aug 12, 2016

First Submission Date that Met QC Criteria

Aug 30, 2016

First Posted Date

Sep 5, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 30, 2016

Last Update Posted Date

Sep 5, 2016Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Olusegun Adekanle, Dr, Obafemi Awolowo University Teaching HospitalPrincipal Investigator

Lead Sponsor

Obafemi Awolowo University Teaching HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed Description

A case control study of patients with erosive GERD. Patients with erosive GERD who had upper gastro-intestinal endoscopy were graded using the Los Angeles classification. Patients and controls had measurements of body mass index (BMI), WC (waist circumference), Waist hip ratio (WHR), and hip circumference (HC). Bio-data was collected from both groups and data were analysed using descriptive and inferential statistics. A p value of equal to or less than 0.05 was considered significant.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

160Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Erosive GERD		Gastroscopy examination.	Other: Gastroscopy
Control population		Gastroscopy examination.	Other: Gastroscopy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Gastroscopy	Other	Upper gastrointestinal endoscopy procedure	Control population Erosive GERD

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Obesity associated with GERD	Measurement of anthropometric indices	Immediate.

Secondary Outcomes

Measure	Description	Time Frame
Body mass index is associated with GERD	Measurement of body mass index (kilogram per meter squared)	Immediate
Waist circumference is associated with GERD	Measurement of waist circumference (centimeter)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients with dyspepsia

Exclusion Criteria:

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Nigerians with dyspeptic symptoms

Sampling Method

Non-Probability Sample

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D005764	Gastroesophageal Reflux
D009765	Obesity

Ancestor Terms

ID	Term
D015154	Esophageal Motility Disorders
D003680	Deglutition Disorders
D004935	Esophageal Diseases
D005767	Gastrointestinal Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D005773	Gastroscopy

Ancestor Terms

ID	Term
D016099	Endoscopy, Gastrointestinal
D016145	Endoscopy, Digestive System
D003938	Diagnostic Techniques, Digestive System
D019937	Diagnostic Techniques and Procedures

Browse Leaves

Not provided

Browse Branches

Not provided