Temple Registry for the Investigation of African American Gastrointestinal Disease Epidemiology

NCT01262755 | Completed Results

• 1 other identifier: K24DK083268
• Study Type: observational
• Target: 450
• Locations: 1 country
• Sites: 1

Brief Summary

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. PUBLIC HEALTH RELEVANCE: This research will help doctors to understand the frequency and risks for esophageal reflux disease (heartburn) in African Americans.

Conditions

Gastroesophageal Reflux Disease; Functional Bowel Disorders

Keywords

GERD; IBS; Minority

Outcome Measures

Primary Outcomes (1)

• Epidemiologic Factors Associated With Prevalent Reflux Disease.

  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 450 African Americans living in North Philadelphia.

  Two years

Study Arms (1)

African Americans

Consists of 450 African Americans living in the zip code surrounding Temple Hospital between the ages of 18 and 80.

Behavioral: Structured Interview

Interventions

Structured Interview BEHAVIORAL

Subjects underwent a structured interview using a laptop computer and answered over 200 standardized questions. All patient had their height, weight, and waist circumference measured.

African Americans

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• newly arrived to zip code
• unable to provide proof of address
• unwilling to come to temple to complete interview

Sponsors & Collaborators

• Temple University: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

Temple University Hospital

Philadelphia, Pennsylvania, 19140, United States

Location

MeSH Terms

Conditions

Gastroesophageal Reflux

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Results Point of Contact

• Title: Frank Friedenberg, MD
• Organization: Temple University

frank.friedenberg@temple.edu

215-707-9900

Study Officials

• Frank K Friedenberg, MD

  Temple University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: December 16, 2010
• First Posted: December 17, 2010
• Study Start: April 1, 2010
• Primary Completion: January 1, 2015
• Study Completion: January 1, 2015
• Last Updated: May 4, 2015
• Results First Posted: May 4, 2015

Record last verified: 2015-04

Locations

US (1)