Pancreatitis Clinical Trial
— IFPancOfficial title:
Intermittent Fasting as a Primary Means for Improving Quality of Life for Acute and Chronic Pancreatitis
The purpose of this research is to compare intermittent fasting with a standard diet approach for improving the quality of life related to your pancreas disease. Our hope is to improve your symptoms and prevent you from needing to go into the hospital for pancreas-related issues.
Status | Not yet recruiting |
Enrollment | 64 |
Est. completion date | April 1, 2026 |
Est. primary completion date | April 1, 2026 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility | Inclusion Criteria: - Age = 18 year - Recurrent acute pancreatitis defined by greater than 2 episodes of pancreatitis, defined by: abdominal pain and either amylase or lipase > 3 x the upper limit of normal, imaging suggestive of, separated by time - Anatomy of chronic pancreatitis defined by Rosemont criterion9 or on imaging (CT, MRI) - Pancreatic exocrine insufficiency defined by a pancreatic elastase < 200 ug/g stool10 Exclusion Criteria: - Age < 18 years - Pregnant Patients - Age > 80 years - Patients who cannot consent for themselves - Glycogen storage disease - Insulinoma or hypoglycemic state - Active alcohol abuse - Alcohol induced acute pancreatitis - Gallstone induced acute pancreatitis - Pancreatic solid neoplasm - Patients with diabetes - Patients on beta blockers |
Country | Name | City | State |
---|---|---|---|
United States | Moffitt Cancer Center | Tampa | Florida |
Lead Sponsor | Collaborator |
---|---|
H. Lee Moffitt Cancer Center and Research Institute |
United States,
Bellizzi AM, Bloomston M, Zhou XP, Iwenofu OH, Frankel WL. The mTOR pathway is frequently activated in pancreatic ductal adenocarcinoma and chronic pancreatitis. Appl Immunohistochem Mol Morphol. 2010 Oct;18(5):442-7. doi: 10.1097/PAI.0b013e3181de115b. — View Citation
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Corley BT, Carroll RW, Hall RM, Weatherall M, Parry-Strong A, Krebs JD. Intermittent fasting in Type 2 diabetes mellitus and the risk of hypoglycaemia: a randomized controlled trial. Diabet Med. 2018 May;35(5):588-594. doi: 10.1111/dme.13595. Epub 2018 Feb 27. — View Citation
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Han S, Patel B, Min M, Bocelli L, Kheder J, Wachholtz A, Wassef W. Quality of life comparison between smokers and non-smokers with chronic pancreatitis. Pancreatology. 2018 Apr;18(3):269-274. doi: 10.1016/j.pan.2018.02.012. Epub 2018 Feb 26. — View Citation
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Javle MM, Shroff RT, Xiong H, Varadhachary GA, Fogelman D, Reddy SA, Davis D, Zhang Y, Wolff RA, Abbruzzese JL. Inhibition of the mammalian target of rapamycin (mTOR) in advanced pancreatic cancer: results of two phase II studies. BMC Cancer. 2010 Jul 14;10:368. doi: 10.1186/1471-2407-10-368. — View Citation
Ji L, Li L, Qu F, Zhang G, Wang Y, Bai X, Pan S, Xue D, Wang G, Sun B. Hydrogen sulphide exacerbates acute pancreatitis by over-activating autophagy via AMPK/mTOR pathway. J Cell Mol Med. 2016 Dec;20(12):2349-2361. doi: 10.1111/jcmm.12928. Epub 2016 Jul 15. — View Citation
Law R, Leal C, Dayyeh BA, Leise MD, Balderramo D, Baron TH, Cardenas A. Role of immunosuppression in post-endoscopic retrograde cholangiopancreatography pancreatitis after liver transplantation: a retrospective analysis. Liver Transpl. 2013 Dec;19(12):1354-60. doi: 10.1002/lt.23758. — View Citation
Wassef W, DeWitt J, McGreevy K, Wilcox M, Whitcomb D, Yadav D, Amann S, Mishra G, Alkaade S, Romagnuolo J, Stevens T, Vargo J, Gardner T, Singh V, Park W, Hartigan C, Barton B, Bova C. Pancreatitis Quality of Life Instrument: A Psychometric Evaluation. Am J Gastroenterol. 2016 Aug;111(8):1177-86. doi: 10.1038/ajg.2016.225. Epub 2016 Jun 14. — View Citation
Wu XM, Ji KQ, Wang HY, Zhao Y, Jia J, Gao XP, Zang B. MicroRNA-339-3p alleviates inflammation and edema and suppresses pulmonary microvascular endothelial cell apoptosis in mice with severe acute pancreatitis-associated acute lung injury by regulating Anxa3 via the Akt/mTOR signaling pathway. J Cell Biochem. 2018 Aug;119(8):6704-6714. doi: 10.1002/jcb.26859. Epub 2018 Apr 25. — View Citation
Yang J, Waldron RT, Su HY, Moro A, Chang HH, Eibl G, Ferreri K, Kandeel FR, Lugea A, Li L, Pandol SJ. Insulin promotes proliferation and fibrosing responses in activated pancreatic stellate cells. Am J Physiol Gastrointest Liver Physiol. 2016 Oct 1;311(4):G675-G687. doi: 10.1152/ajpgi.00251.2016. Epub 2016 Sep 8. — View Citation
* Note: There are 15 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Pancreas related Quality of Life Index (PANQALI) | Pancreas related Quality of Life Index (PANQALI) is pancreas related quality of life index scale from 0 (lowest or better disease activity) to 90 (highest or worse disease activity) | 24 weeks | |
Secondary | Pain scores | standard score from 0-10 (0 no pain, 10 worst pain) | 24 weeks | |
Secondary | Oral Morphine Equivalent Daily Dosing | total dose of opiates taken converted into morphine in milligrams | 24 weeks | |
Secondary | Patient weight | pounds | 24 weeks | |
Secondary | Patient Body mass index | pounds/inch squared | 24 weeks | |
Secondary | Vitamin D 25-OH levels | levels of vitamin D 25-OH in nanograms/milliLiter | 24 weeks | |
Secondary | stool pancreatic elastase levels | stool elastase level in micrograms/gram | 24 weeks | |
Secondary | Readmissions | number of participants that need to seek medical care | 24 weeks | |
Secondary | Length of Stay | days requiring medical care | 24 weeks |
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