Exocrine Pancreatic InsufficiencyNCT04690738
Role of Pancreatic Exocrine Secretion in Weight Gain After Pancreas Transplantation
An observational study of Exocrine Pancreatic Insufficiency and Weight Gain, run by Rush University Medical Center at 1 site in United States.
Trial summary
Pancreas transplantation is currently the most reliable method for glycemic control in insulin dependent diabetic patients. Outcomes of pancreas transplantation have improved significantly over the years due to improved surgical techniques, medical management and immunosuppression. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Exocrine Pancreatic Insufficiency, Weight Gain
- What is being tested?
- Fecal Elastase Concentration
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Aug 2020to 31 Dec 2030
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Recipients of pancreas transplant with or without kidney transplant
Who may be able to join
- Recipients of pancreas transplant with or without other organs
- Age 18 - 80 yrs
Who cannot join
- Unwillingness to consent or participate in the study
Trial locations and contacts
1 site in 1 country.
United States1 site
Rush University Medical Center
Chicago, Illinois, 60612
About this study
Pancreas transplantation is currently the most reliable method for glycemic control in insulin dependent diabetic patients. Outcomes of pancreas transplantation have improved significantly over the years due to improved surgical techniques, medical management and immunosuppression. However, weight gain after pancreas transplantation remains a common problem with associated consequences such as development of type 2 diabetes, coronary artery disease, graft loss, metabolic syndrome and increased risk of cardiovascular death. Excessive weight gain is well known after liver and kidney transplantation; however there are very few studies that have looked at weight gain after pancreas transplantation. In a recent study by Knight et al, 26% of the pancreas transplant recipients had excessive weight gain, defined as more than 30% of their baseline weight by 1-year post transplant. The study focused mainly on the endocrine function of the pancreas, explaining that excessive peripheral insulin circulation post-transplant may explain the weight gain. Other factors like immunosuppression, increased oral intake and potentially reduced activity may also have played a role. However no study has looked at the possible role of exocrine secretion from the new pancreatic allograft, combined with exocrine secretion of the old pancreas, leading to excessive availability of digestive juices like trypsin, chymotrypsin, lipase, amylase, gelatinase, elastase etc. Our hypothesis is that the excessive weight gain after pancreas transplant, which is more than in other solid organ transplants, is driven by the excessive digestive juice leading to improved conversion of available food and nutrient into storable energy and subsequently leading to weight gain. The patient will therefore need to either increase physical activity to avoid weight gain post-transplant or significantly reduce caloric intake.
Fecal elastase test (FE-1)-elastase is a proteolytic enzyme produced by pancreatic acinar cells. They bind to bile salt and pass through the gut without degradation. These levels correlate well with the other pancreatic enzyme levels. Fecal elastase concentration (FEC) has been used routinely to screen for pancreatic exocrine insufficiency (PEI).
Exocrine pancreatic juice has been a target for the management of obesity lately, with the use of drugs like Orlistat (Xenical) that inhibits pancreatic lipase and therefore interfere with the absorption of fat. If our theory of excessive pancreatic juice availability after pancreas transplant can be proven, it can help guide the targeted use and appropriate dosing of such drugs based on the level of the pancreatic juice as measured by the FEC.
Read the detailed description
This is the second of a two-part study. The first part, a pilot study, assessed the FEC level after pancreas transplant to determine if FEC is high compared to that of the general population and see if particularly high levels correlate with post pancreas transplant weight gain. The pilot study demonstrated excessively high FEC relative to the general population/healthy individuals, and much higher than the upper limit of the assay. However, the study did not show correlation between weight gain and high post-transplant FEC. This is thought to be because majority of the subjects enrolled were years from their transplant and the high FEC and weight gain already occurred early post-transplant. The study showed that FEC level was particularly high early post-transplant and decreased gradually over the years. It also showed that most weight gain occurred between years
1 to 2 post-transplant; we therefore felt the pilot study might have missed the period when the high level of exocrine secretion contributed to the weight gain. The primary aim of this second part is to assess patients from pre-transplant period to post-transplant period and see if FEC early posttransplant correlates with weight gain, particularly during the period of post-transplant weight gain established from results of the pilot study. The relationship between obesity and the gut microbiome is still not well established. To understand the role of gut microbiome in pancreas transplant patients, we will assess gut microbiome and other gut factors that may help us determine if the weight gain is related to lifestyle changes or it is associated with pancreas transplant.
- Conditions
- Exocrine Pancreatic Insufficiency, Weight Gain
- Being tested
- Fecal Elastase Concentration
- Keywords
- pancreas transplant, weight gain, pancreatic insufficiency, kidney pancreas transplant
- Medical subject headings
- Exocrine Pancreatic Insufficiency, Weight Gain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fecal Elastase ConcentrationDiagnostic test
Stool sample for fecal elastase-1 (FEC) analysis and microbiome for sequencing and analysis will be obtained pre- and post-transplant.
| Study group | Role | What they receive |
|---|---|---|
| Post Pancreas Transplant Patients | Pancreas transplant recipients Receives: Diagnostic Test: Fecal Elastase Concentration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Concentration of Fecal Elastase-1, measured in mcg/g, correlation with post-transplant weight
Measured: Follow-up for up to 3 years post-transplant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2020
- Study start17 Aug 2020
- Primary completion31 Dec 2030 (estimated)
- Study completion31 Dec 2030 (estimated)
Why it stopped: Currently lack of funding and study staff
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Exocrine Pancreatic InsufficiencyStudies of the same condition, open and under way.
- More trials run by Rush University Medical CenterThe 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
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rush University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Oyedolamu Olaitan, MBBS, Principal investigator, Rush University Medical CenterAmanda Van Jacobs, MS, Study director, Rush University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04690738
- Sponsor's protocol ID
- 20052109
- Status last verified
- Jan 2026
- First submitted
- 31 Jul 2020
- Last updated
- 3 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Knight RJ, Islam AK, Pham C, Graviss EA, Nguyen DT, Moore LW, Kagan A, Sadhu AR, Podder H, Gaber AO. Weight Gain After Simultaneous Kidney and Pancreas Transplantation. Transplantation. 2020 Mar;104(3):632-639. doi: 10.1097/TP.0000000000002862.
PubMed 31335775Ewald N, Raspe A, Kaufmann C, Bretzel RG, Kloer HU, Hardt PD. Determinants of Exocrine Pancreatic Function as Measured by Fecal Elastase-1 Concentrations (FEC) in Patients with Diabetes mellitus. Eur J Med Res. 2009 Mar 17;14(3):118-22. doi: 10.1186/2047-783x-14-3-118.
PubMed 19380282Dominguez-Munoz JE, D Hardt P, Lerch MM, Lohr MJ. Potential for Screening for Pancreatic Exocrine Insufficiency Using the Fecal Elastase-1 Test. Dig Dis Sci. 2017 May;62(5):1119-1130. doi: 10.1007/s10620-017-4524-z. Epub 2017 Mar 17.
PubMed 28315028Forsmark C, Adams PC. Pancreatic function testing--valuable but underused. Can J Gastroenterol. 2009 Aug;23(8):529-30. doi: 10.1155/2009/464326. No abstract available.
PubMed 19668794Van Jacobs A, Williams MD, Ralph OG, Becerra AZ, Chan EY, Olaitan O. Pancreatic Exocrine Secretion and Weight Gain After Pancreas Transplantation. Prog Transplant. 2023 Sep;33(3):236-241. doi: 10.1177/15269248231189877. Epub 2023 Jul 30.
PubMed 37518975
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Pancreatic Exocrine Secretion in Weight Gain After Pancreas Transplantation
- ClinicalTrials.gov ID
- NCT04690738
- Acronym / sponsor ID
- 20052109
- Conditions
- Exocrine Pancreatic Insufficiency, Weight Gain
- Keywords
- pancreas transplant, weight gain, pancreatic insufficiency, kidney pancreas transplant
- Study type
- Observational
- Recruitment status
- SuspendedReason stopped: Currently lack of funding and study staff
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Rush University Medical CenterUniversity, hospital or other
- Study start
- 17 Aug 2020 (actual)
- Primary completion
- 31 Dec 2030 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 31 Dec 2020 (actual)
- 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.
Pancreas transplantation is currently the most reliable method for glycemic control in insulin dependent diabetic patients. Outcomes of pancreas transplantation have improved significantly over the years due to improved surgical techniques, medical management and immunosuppression. However, weight gain after pancreas transplantation remains a common problem with associated consequences such as development of type 2 diabetes, coronary artery disease, graft loss, metabolic syndrome and increased risk of cardiovascular death. Excessive weight gain is well known after liver and kidney transplantation; however there are very few studies that have looked at weight gain after pancreas transplantation. In a recent study by Knight et al, 26% of the pancreas transplant recipients had excessive weight gain, defined as more than 30% of their baseline weight by 1-year post transplant. The study focused mainly on the endocrine function of the pancreas, explaining that excessive peripheral insulin circulation post-transplant may explain the weight gain. Other factors like immunosuppression, increased oral intake and potentially reduced activity may also have played a role. However no study has looked at the possible role of exocrine secretion from the new pancreatic allograft, combined with exocrine secretion of the old pancreas, leading to excessive availability of digestive juices like trypsin, chymotrypsin, lipase, amylase, gelatinase, elastase etc. Our hypothesis is that the excessive weight gain after pancreas transplant, which is more than in other solid organ transplants, is driven by the excessive digestive juice leading to improved conversion of available food and nutrient into storable energy and subsequently leading to weight gain. The patient will therefore need to either increase physical activity to avoid weight gain post-transplant or significantly reduce caloric intake.
Fecal elastase test (FE-1)-elastase is a proteolytic enzyme produced by pancreatic acinar cells. They bind to bile salt and pass through the gut without degradation. These levels correlate well with the other pancreatic enzyme levels. Fecal elastase concentration (FEC) has been used routinely to screen for pancreatic exocrine insufficiency (PEI).
Exocrine pancreatic juice has been a target for the management of obesity lately, with the use of drugs like Orlistat (Xenical) that inhibits pancreatic lipase and therefore interfere with the absorption of fat. If our theory of excessive pancreatic juice availability after pancreas transplant can be proven, it can help guide the targeted use and appropriate dosing of such drugs based on the level of the pancreatic juice as measured by the FEC.
Detailed description
This is the second of a two-part study. The first part, a pilot study, assessed the FEC level after pancreas transplant to determine if FEC is high compared to that of the general population and see if particularly high levels correlate with post pancreas transplant weight gain. The pilot study demonstrated excessively high FEC relative to the general population/healthy individuals, and much higher than the upper limit of the assay. However, the study did not show correlation between weight gain and high post-transplant FEC. This is thought to be because majority of the subjects enrolled were years from their transplant and the high FEC and weight gain already occurred early post-transplant. The study showed that FEC level was particularly high early post-transplant and decreased gradually over the years. It also showed that most weight gain occurred between years
1 to 2 post-transplant; we therefore felt the pilot study might have missed the period when the high level of exocrine secretion contributed to the weight gain. The primary aim of this second part is to assess patients from pre-transplant period to post-transplant period and see if FEC early posttransplant correlates with weight gain, particularly during the period of post-transplant weight gain established from results of the pilot study. The relationship between obesity and the gut microbiome is still not well established. To understand the role of gut microbiome in pancreas transplant patients, we will assess gut microbiome and other gut factors that may help us determine if the weight gain is related to lifestyle changes or it is associated with pancreas transplant.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Post Pancreas Transplant Patients | – | Diagnostic Test: Fecal Elastase ConcentrationPancreas transplant recipients |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Recipients of pancreas transplant with or without kidney transplant
Key inclusion criteria (2 listed)
- Recipients of pancreas transplant with or without other organs
- Age 18 - 80 yrs
Key exclusion criteria (1 listed)
- Unwillingness to consent or participate in 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.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fecal Elastase ConcentrationStool sample for fecal elastase-1 (FEC) analysis and microbiome for sequencing and analysis will be obtained pre- and post-transplant. | Diagnostic test | Post Pancreas Transplant Patients |
Primary outcome
Concentration of Fecal Elastase-1, measured in mcg/g, correlation with post-transplant weight
Time frame: Follow-up for up to 3 years post-transplant
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2026.
- Background: PubMed 31335775Knight RJ, Islam AK, Pham C, Graviss EA, Nguyen DT, Moore LW, Kagan A, Sadhu AR, Podder H, Gaber AO. Weight Gain After Simultaneous Kidney and Pancreas Transplantation. Transplantation. 2020 Mar;104(3):632-639. doi: 10.1097/TP.0000000000002862.
- Background: PubMed 19380282Ewald N, Raspe A, Kaufmann C, Bretzel RG, Kloer HU, Hardt PD. Determinants of Exocrine Pancreatic Function as Measured by Fecal Elastase-1 Concentrations (FEC) in Patients with Diabetes mellitus. Eur J Med Res. 2009 Mar 17;14(3):118-22. doi: 10.1186/2047-783x-14-3-118.
- Background: PubMed 28315028Dominguez-Munoz JE, D Hardt P, Lerch MM, Lohr MJ. Potential for Screening for Pancreatic Exocrine Insufficiency Using the Fecal Elastase-1 Test. Dig Dis Sci. 2017 May;62(5):1119-1130. doi: 10.1007/s10620-017-4524-z. Epub 2017 Mar 17.
- Background: PubMed 19668794Forsmark C, Adams PC. Pancreatic function testing--valuable but underused. Can J Gastroenterol. 2009 Aug;23(8):529-30. doi: 10.1155/2009/464326. No abstract available.
- Results publication: PubMed 37518975Van Jacobs A, Williams MD, Ralph OG, Becerra AZ, Chan EY, Olaitan O. Pancreatic Exocrine Secretion and Weight Gain After Pancreas Transplantation. Prog Transplant. 2023 Sep;33(3):236-241. doi: 10.1177/15269248231189877. Epub 2023 Jul 30.
- Individual participant dataSharing planned: No
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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.
Oyedolamu Olaitan, MBBS principal investigator
Rush University Medical Center
Amanda Van Jacobs, MS study director
Rush University Medical Center
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 Exocrine Pancreatic Insufficiency and Weight Gain, run by Rush University Medical Center 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 2 inclusion and 1 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: paused, as of the sponsor's last update on 3 Feb 2026. 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?
Results are not available in the source record.
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?
Concentration of Fecal Elastase-1, measured in mcg/g, correlation with post-transplant weight (time frame: Follow-up for up to 3 years post-transplant). 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 NCT04690738, which also lists 5 linked publications.
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 3 Feb 2026.