Intermittent Fasting for Pancreatitis

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Brief Title

Intermittent Fasting for Pancreatitis

Official Title

Intermittent Fasting as a Primary Means for Improving Quality of Life for Acute and Chronic Pancreatitis

Brief Summary

      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.
    

Detailed Description

      Fasting is a classic means for religious discipline, yet recently regaining favor in the
      medical landscape. Numerous studies have come forth, both in animals and humans outlining the
      benefit of intermittent fasting (IF) on various disease states and longevity. Though a
      relatively complex cellular process, fasting for at least 8-12 hours has been shown to lead
      to fatty acid release from a patient's adipose storage. These fatty acids then shuttle to the
      liver, where they are converted to ketones such as beta-hydroxybutyrate and acetoacetate.

      Ketones are then utilized for energy sources in the heart, brain and skeletal muscle tissue.
      The energy produced (ATP), then leads to increase in the cellular powerhouses, the
      mitochondria and autophagy or cell recycling. This cellular recycling is one main way in
      which IF has proven benefit for inflammatory conditions and in cancer care.

      Furthermore, reductions in amino acids and glucose due to fasting and reliance on ketones as
      energy, lead to down regulation of the mTOR pathway. Much is known regarding the mTOR
      pathway. Down regulation of mTOR is associated with increased autophagy (as above), lower
      protein and lipid synthesis, ribosome and lysosome creation (cell shuttles) and lowered
      energy use.

      Specific to the pancreas, mTOR down regulation has been shown to lower protein synthesis with
      the pancreas, caused by cholecystokinin (CCK), a pancreas stimulating hormone.2 The effect of
      this leads to lower pancreatic enzymes secretion. Inhibition of mTOR also lowers the
      generation of fibroblasts, the scar-tissue cells within the pancreas, leading to less
      scar-formation.3 Scar tissue formation is a vital part of morbidity and complications for
      patients with chronic pancreatitis.

      Pancreatic disease-modulation has also been evaluated in regard to the mTOR pathway.4 For
      pancreatic cancer, rapamycin a mTOR inhibitor have been implicated as targets for
      chemotherapy. Clinical trials have shown benefit for pancreatic cancer cases given rapamycin
      in concert with other chemotherapeutic medications.5 For acute, chronic pancreatitis and
      post-ERCP pancreatitis, mTOR is usually activated.6 In particular, blocking the mTOR pathway
      can favor autophagy, limit cell death (apoptosis) and hence necrosis of the pancreas.
      Necrosis in pancreatitis, leads to complex disease, possess a higher mortality, organ
      failure, and can make the clinical course more complicated. Therefore, the mTOR pathway has
      been implicated as a potential therapeutic target to ameliorate disease course and
      severity.4,7,8 The purpose of this study is to evaluate IF as a means for limiting disease
      severity with people who have recurrent acute pancreatitis and chronic pancreatitis. Our
      hypothesis is that IF will improve pancreatic-disease related quality of life.1
    


Study Type

Interventional


Primary Outcome

Pancreas related Quality of Life Index (PANQALI)

Secondary Outcome

 Pain scores

Condition

Pancreatitis

Intervention

Intermittent Fasting

Study Arms / Comparison Groups

 Intermittent Fasting
Description:  Patients in Group A will then receive information regarding intermittent fasting, which would include fasting for a 16-hour period each day, followed by ingestion of an appropriate number of calories for the remaining part of the day.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Other

Estimated Enrollment

64

Start Date

March 1, 2021

Completion Date

March 1, 2023

Primary Completion Date

March 1, 2023

Eligibility Criteria

        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
      

Gender

All

Ages

18 Years - 80 Years

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

, 4404065500, [email protected]

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT04760847

Organization ID

STUDY20201373


Responsible Party

Principal Investigator

Study Sponsor

University Hospitals Cleveland Medical Center


Study Sponsor

, , 


Verification Date

February 2021