Pancreatic Insufficiency Secondary to Tobacco Exposure

Sponsor

Emory University (Other)

Overall Status

Completed

CT.gov ID

NCT01988350

Collaborator

(none)

202

Enrollment

Location

Duration (Months)

66.8

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Pancreatic Insufficiency

Study Design

Study Type:

Observational

Actual Enrollment :

202 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Pancreatic Insufficiency Secondary to Tobacco Exposure

Study Start Date :

May 1, 2013

Actual Primary Completion Date :

Aug 1, 2013

Actual Study Completion Date :

Aug 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Non-smokers
Smokers

Outcome Measures

Primary Outcome Measures

pancreatic insufficency [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

Eligibility Criteria

Criteria

Ages Eligible for Study:

30 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Male or female at least 30 years of age
Able to read, understand, and sign informed consent
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:

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