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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02888808
Other study ID # ERC/2009/03/07
Secondary ID
Status Completed
Phase N/A
First received August 12, 2016
Last updated August 30, 2016
Start date March 2013
Est. completion date December 2015

Study information

Verified date August 2016
Source Obafemi Awolowo University Teaching Hospital
Contact n/a
Is FDA regulated No
Health authority Nigeria: Federal Ministry of Health
Study type Observational

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Completed
Enrollment 160
Est. completion date December 2015
Est. primary completion date December 2015
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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.

Study Design

Observational Model: Case Control, Time Perspective: Prospective


Related Conditions & MeSH terms


Intervention

Other:
Gastroscopy
Upper gastrointestinal endoscopy procedure

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Obafemi Awolowo University Teaching Hospital

Outcome

Type Measure Description Time frame Safety issue
Primary Obesity associated with GERD Measurement of anthropometric indices Immediate. Yes
Secondary Body mass index is associated with GERD Measurement of body mass index (kilogram per meter squared) Immediate Yes
Secondary Waist circumference is associated with GERD Measurement of waist circumference (centimeter) Immediate Yes
Secondary Waist hip ratio is associated with GERD Measurement of waist hip ratio Immediate Yes