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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01988350
Other study ID # IRB00064360
Secondary ID
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


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
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