Role of Pancreatic Exocrine Secretion in Weight Gain After Pancreas Transplantation

NCT04690738 | Suspended

• 1 other identifier: 20052109
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Weight Gain; Exocrine Pancreatic Insufficiency

Keywords

pancreas transplant; weight gain; pancreatic insufficiency; kidney pancreas transplant

Outcome Measures

Primary Outcomes (1)

• Concentration of Fecal Elastase-1, measured in mcg/g, correlation with post-transplant weight

  Follow-up for up to 3 years post-transplant

Study Arms (1)

Post Pancreas Transplant Patients

Pancreas transplant recipients

Diagnostic Test: Fecal Elastase Concentration

Interventions

Fecal Elastase Concentration DIAGNOSTIC_TEST

Stool sample for fecal elastase-1 (FEC) analysis and microbiome for sequencing and analysis will be obtained pre- and post-transplant.

Post Pancreas Transplant Patients

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Recipients of pancreas transplant with or without kidney transplant

You may qualify if:

• Recipients of pancreas transplant with or without other organs
• Age 18 - 80 yrs

You may not qualify if:

• Unwillingness to consent or participate in the study

Sponsors & Collaborators

• Rush University Medical Center: lead

Study Sites (1)

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

Related Publications (5)

• 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.

  PMID: 31335775 BACKGROUND

• Ewald 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.

  PMID: 19380282 BACKGROUND

• Dominguez-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.

  PMID: 28315028 BACKGROUND

• Forsmark 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.

  PMID: 19668794 BACKGROUND

• Van 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.

  PMID: 37518975 RESULT

MeSH Terms

Conditions

Exocrine Pancreatic Insufficiency; Weight Gain

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Oyedolamu Olaitan, MBBS

  Rush University Medical Center

  PRINCIPAL INVESTIGATOR

• Amanda Van Jacobs, MS

  Rush University Medical Center

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 31, 2020
• First Posted: December 31, 2020
• Study Start: August 17, 2020
• Primary Completion (Estimated): December 31, 2030
• Study Completion (Estimated): December 31, 2030
• Last Updated: February 3, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)