Pancreatic Insufficiency Secondary to Tobacco Exposure

NCT01988350 | Completed

• 1 other identifier: IRB00064360
• Study Type: observational
• Target: 202
• Locations: 1 country
• Sites: 1

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.

Conditions

Pancreatic Insufficiency

Keywords

pancreatic insufficiency; pancreatic elastase; fecal elastase; smoking; tobacco

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Non-smokers

Smokers

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Emory University: lead

Study Sites (1)

The Emory Clinic

Atlanta, Georgia, 30322, United States

Location

Related Publications (1)

• Raphael KL, Chawla S, Kim S, Keith CG, Propp DR, Chen ZN, Woods KE, Keilin SA, Cai Q, Willingham FF. Pancreatic Insufficiency Secondary to Tobacco Exposure: A Controlled Cross-Sectional Evaluation. Pancreas. 2017 Feb;46(2):237-243. doi: 10.1097/MPA.0000000000000721.

  PMID: 27846134 DERIVED

MeSH Terms

Conditions

Exocrine Pancreatic Insufficiency; Smoking

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Behavior

Study Officials

• Field F Willingham, MD, MPH

  Emory University School of Medicine, Division of Gastroenterology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Endoscopy

Study Record Dates

• First Submitted: July 24, 2013
• First Posted: November 20, 2013
• Study Start: May 1, 2013
• Primary Completion: August 1, 2013
• Study Completion: August 1, 2013
• Last Updated: November 20, 2013

Record last verified: 2013-11

Locations

US (1)