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OpenTrials
Completed

NCT Number: NCT01988350

Pancreatic Insufficiency Secondary to Tobacco Exposure

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.

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Key information

Age range

30 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

The Emory Clinic

Atlanta, Georgia, 30322, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Emory University

Other

Registry information

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Nov 20, 2013
Registry last updated
Nov 20, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.