NCT01954667

Brief Summary

evaluate the impact of different anthropometric measures on clinical and endoscopic severity of GERD and its relation to serum leptin.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2012

Geographic Reach
1 country

1 active site

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

January 1, 2012

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2013

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 29, 2013

Completed
8 days until next milestone

First Posted

Study publicly available on registry

October 7, 2013

Completed
Last Updated

October 7, 2013

Status Verified

September 1, 2013

Enrollment Period

1.6 years

First QC Date

September 29, 2013

Last Update Submit

September 29, 2013

Conditions

Gastroesophageal Reflux Disease

Keywords

Gastroesophageal Reflux Disease; Anthropometric Measures; Leptin

Outcome Measures

Primary Outcomes (1)

  • Impact of anthropometric measures on GERD

    evaluate the impact of different anthropometric measures on clinical and endoscopic severity of GERD and its relation to serum leptin.

    1 year

Study Arms (3)

obese and overweight

Group1 (n=30): overweight and obese (BMI ≥25 and/ or WHtR≥0.5)

average body weight

Group2 (n=30): normal weight (BMI ≥ 18 to \< 25 and/or WHtR ≥0.4 to \<0.5)

Control group

Control Group (n= 20): healthy subjects, matched for age and gender, were included in this study. All included controls had average weight (BMI ≥ 18 to \< 25 and/ or WHtR ≥0.4 to \<0.5)

Eligibility Criteria

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

This prospective, case-controlled study included 60 Egyptian patients who attended Ain Shams University Hospitals and Theodor Bilharz Research Institute; Cairo, Egypt

You may qualify if:

  • Gastro esophageal reflux symptoms (e.g. heart burn, regurgitation, water brash or atypical symptoms such as hoarseness of voice, asthma and cough)
  • complete upper gastrointestinal endoscopy.

You may not qualify if:

  • Receiving medication for reflux disease (including proton pump inhibitor, histamine type 2 receptors blocker, prokinetic agents) in the previous month.
  • Pregnant woman.
  • History of upper abdominal surgery.
  • Severe co-morbidity as cirrhosis, end-stage renal disease and heart failure.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tropical medicine department

Cairo, Egypt

Location

MeSH Terms

Conditions

Gastroesophageal Reflux

Condition Hierarchy (Ancestors)

Esophageal Motility DisordersDeglutition DisordersEsophageal DiseasesGastrointestinal DiseasesDigestive System Diseases

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Target Duration
6 Weeks
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of tropical medicine , Ain Shams university

Study Record Dates

First Submitted

September 29, 2013

First Posted

October 7, 2013

Study Start

January 1, 2012

Primary Completion

August 1, 2013

Study Completion

August 1, 2013

Last Updated

October 7, 2013

Record last verified: 2013-09

Locations

EG(1)