Temple Registry for the Investigation of African American Gastrointestinal Disease Epidemiology (TRIAGE)

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Temple University
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Frank K. Friedenberg, Temple University
ClinicalTrials.gov Identifier:
NCT01262755
First received: December 16, 2010
Last updated: May 15, 2014
Last verified: May 2014
  Purpose

DESCRIPTION: Minimal data exists on the prevalence of gastroesophageal reflux disease in minority populations. Specific objectives of this K24 research project are to: (1) Provide an estimate of the prevalence of gastroesophageal reflux disease in an urban, African American population; (2) Determine whether specific risk factors including diet, tobacco use, physical activity, and psychosocial stress are important in the targeted population. We will also measure height, weight, and waist/hip circumference to determine the impact of central obesity on reflux; (3) To identify the importance of race and identify risk factors for gastroesophageal reflux disease unique to the African Americans population by using a control group composed of Caucasians; PUBLIC HEALTH RELEVANCE: This research will help doctors to understand the frequency and risks for esophageal reflux disease (heartburn) in African Americans.


Condition
Gastroesophageal Reflux Disease
Functional Bowel Disorders

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: Temple Registry for the Investigation of African American Gastrointestinal Disease Epidemiology

Resource links provided by NLM:


Further study details as provided by Temple University:

Primary Outcome Measures:
  • Epidemiologic factors associated with prevalent reflux disease. [ Time Frame: Two years ] [ Designated as safety issue: No ]
    Patients will complete a series of standardized questionnaires to determine the prevalence of reflux disease and risk factors for its development. We will query diet, depression, drug, tobacco, and alcohol use as well as a variety of other factors. We will study 750 African Americans and have 250 caucasian controls all from the same community in North Philadelphia.


Secondary Outcome Measures:
  • Longitudinal study on incidence of reflux disease [ Time Frame: 10 years ] [ Designated as safety issue: No ]
    We will follow the established cohort over 10 years to look at the incidence of reflux disease as well as the incidence of functional bowel disorders in African Americans.


Estimated Enrollment: 1000
Study Start Date: April 2010
Estimated Study Completion Date: June 2020
Estimated Primary Completion Date: January 2020 (Final data collection date for primary outcome measure)
Groups/Cohorts
African Americans
Consists of 750 African Americans living in the zip code surrounding Temple Hospital between the ages of 18 and 80.
Caucasian comparison group
Consists of 250 Caucasian Americans living in the zip code surrounding Temple Hospital between the ages of 18 and 80.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

All adult individuals (age 18-80)residing in the 19140 zip code area will be eligible for participation. We will interview 750 African American residents and 250 self-described Caucasian residents.

Criteria

Inclusion Criteria:

  • age over 18
  • self-described African American or Caucasian
  • lived in zip code for > 3 years

Exclusion Criteria:

  • newly arrived to zip code
  • unable to provide proof of address
  • unwilling to come to temple to complete interview
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01262755

Locations
United States, Pennsylvania
Temple University Hospital Recruiting
Philadelphia, Pennsylvania, United States, 19140
Contact: Amiya Palit, MD    215-707-5477      
Contact: Frank Friedenberg, MD    215-707-4391    frank.friedenberg@temple.edu   
Principal Investigator: Frank K Friedenberg, MD         
Sub-Investigator: Amiya Palit, MD         
Sponsors and Collaborators
Temple University
Investigators
Principal Investigator: Frank K Friedenberg, MD Temple University
  More Information

Additional Information:
No publications provided

Responsible Party: Frank K. Friedenberg, Professor of Medicine, Temple University
ClinicalTrials.gov Identifier: NCT01262755     History of Changes
Other Study ID Numbers: K24DK083268, K24DK083268
Study First Received: December 16, 2010
Last Updated: May 15, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Temple University:
GERD
IBS
Minority

Additional relevant MeSH terms:
Gastrointestinal Diseases
Gastroesophageal Reflux
Digestive System Diseases
Intestinal Diseases
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases

ClinicalTrials.gov processed this record on August 27, 2014