Pancreatic InsufficiencyNCT01988350
Pancreatic Insufficiency Secondary to Tobacco Exposure
An observational study of Pancreatic Insufficiency, run by Emory University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 30 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pancreatic Insufficiency
- How many people
- 202 participants
- Where
- 1 siteUnited States
- Study dates
- May 2013to Aug 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Smokers and non-smoking controls without a h/o pancreatic disease.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
- Medical subject headings
- Exocrine Pancreatic Insufficiency, Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Non-smokers | Not described | |
| Smokers | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
pancreatic insufficency
The primary outcome is presence or absence of pancreatic insufficiency as determined by fecal elastase-1 measurement
Measured: 1-2 weeks after provision of stool specimen
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2013 (estimated)
- Study startMay 2013
- Primary completionAug 2013
- Study completionAug 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pancreatic InsufficiencyStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 202 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Field Willingham MD, Emory University
- Investigators
- Field F Willingham, MD, MPH, Principal investigator, Emory University School of Medicine, Division of Gastroenterology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01988350
- Sponsor's protocol ID
- IRB00064360
- Status last verified
- Nov 2013
- First submitted
- 24 Jul 2013
- Last updated
- 20 Nov 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 27846134
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pancreatic Insufficiency Secondary to Tobacco Exposure
- ClinicalTrials.gov ID
- NCT01988350
- Acronym / sponsor ID
- IRB00064360
- Conditions
- Pancreatic Insufficiency
- Keywords
- pancreatic insufficiency, pancreatic elastase, fecal elastase, smoking, tobacco
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 202 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Study start
- May 2013
- Primary completion
- Aug 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 20 Nov 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Non-smokers | – | – |
| Smokers | – | – |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Smokers and non-smoking controls without a h/o pancreatic disease.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2013.
- Derived from this study: PubMed 27846134Raphael 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Field F Willingham, MD, MPH principal investigator
Emory University School of Medicine, Division of Gastroenterology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pancreatic Insufficiency, run by Emory University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pancreatic insufficency (time frame: 1-2 weeks after provision of stool specimen). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01988350, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2013.