Pancreatic Insufficiency Secondary to Tobacco Exposure

Pancreatic Insufficiency Clinical Trial

Official title:

Pancreatic Insufficiency Secondary to Tobacco Exposure

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01988350
• Other study ID #: IRB00064360
• Status: Completed
• Phase: N/A
• First received: July 24, 2013
• Last updated: November 13, 2013
• Start date: May 2013
• Est. completion date: August 2013

Study information

• Verified date: November 2013
• Source: Emory University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 202
• Est. completion date: August 2013
• Est. primary completion date: August 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 30 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Exocrine Pancreatic Insufficiency
• Pancreatic Insufficiency

Locations

Country	Name	City	State
United States	The Emory Clinic	Atlanta	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
Emory University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	pancreatic insufficency	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	No