Pancreatic Insufficiency Secondary to Tobacco Exposure

November 13, 2013 updated by: Field Willingham MD, Emory University
Pancreatic insufficiency is a condition in which there is a decrease in the production and release of enzymes made in the pancreas, which causes nutrient malabsorption. There are many chronic diseases that can lead to pancreatic insufficiency. In the early stages of this disease, a patient may not experience any symptoms, and the prevalence of pancreatic insufficiency may be underestimated. Smoking has long been recognized as a cause of disease in many organs in the body. Cigarette smoke causes inflammation and damages tissue, including the pancreas. Studies have shown that smoking is an independent risk factor for pancreatic cancer and chronic pancreatitis. It has also been shown that the more a person smokes, the worse his disease will be. Additionally, there are studies that show that smokers have nutritional deficiencies. There are observational and retrospective studies that suggest that pancreatic insufficiency may also be caused by smoking. However, this has not been established, and the relationship has not been examined in a controlled manner. This study examines the relationship between smoking and pancreatic insufficiency in patients who do not have other pancreatic diseases.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

202

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • The Emory Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Smokers and non-smoking controls without a h/o pancreatic disease.

Description

Inclusion Criteria:

  1. Male or female at least 30 years of age
  2. Able to read, understand, and sign informed consent
  3. Patients with a negligible smoking history (defined as no smoking for the past 7 years, and a total smoking history ≤ 5 pack-years) OR patients with AT LEAST a 20 pack-year smoking history

Exclusion Criteria:

  1. Patients with a prior diagnosis of pancreatic insufficiency
  2. Patients who have a current or remote history of acute or chronic pancreatitis or any other primary pancreatic disease or malignancy
  3. Patients who have had pancreatic surgery
  4. Patients with a diagnosis of small bowel malabsorption or Celiac disease
  5. Patients with any other significant systemic disease that is deemed by the investigator as possibly interfering with the conduct or interpretation of the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Non-smokers
Smokers

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
pancreatic insufficency
Time Frame: 1-2 weeks after provision of stool specimen
The primary outcome is presence or absence of pancreatic insufficiency as determined by fecal elastase-1 measurement
1-2 weeks after provision of stool specimen

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Emory University

Investigators

  • Principal Investigator: Field F Willingham, MD, MPH, Emory University School of Medicine, Division of Gastroenterology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2013

Primary Completion (Actual)

August 1, 2013

Study Completion (Actual)

August 1, 2013

Study Registration Dates

First Submitted

July 24, 2013

First Submitted That Met QC Criteria

November 13, 2013

First Posted (Estimate)

November 20, 2013

Study Record Updates

Last Update Posted (Estimate)

November 20, 2013

Last Update Submitted That Met QC Criteria

November 13, 2013

Last Verified

November 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB00064360

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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