NEW ONSET ENDOCRINE DYSFUNCTION AFTER ACUTE PANCREATITIS
NEW ONSET ENDOCRINE DYSFUNCTION AFTER ACUTE PANCREATITIS
AIMS AND OBJECTIVES

 1. To evaluate whether acute pancreatitis results in increased endocrine dysfunction or
 not?

 2. To evaluate whether severity of acute pancreatitis have an impact on the development of
 endocrine dysfunction or not?

 1.4 MATERIALS AND METHODS:- Definitions … 1) Acute pancreatitis…..Acute pancreatitis is best
 defined clinically by a patient presenting with 2 of the following 3 criteria: (1)
 symptoms(e.g., epigastric pain) consistent with pancreatitis, (2) a serum amylase or lipase
 level greater than 3 times the laboratory's upper limit of normal, and (3) radiologic imaging
 consistent with pancreatitis, usually using CT or MRI.The AtlantaCriteria revision of 2012
 classifies severity as mild, moderately severe, or severe. Mild acute pancreatitis has no
 organ failure, no local or systemic complications.Moderately-severe acute pancreatitis is
 defined by the presence of transient organ failure (lasting <48 hours) and/or local
 complications.Severe acute pancreatitis is defined by persistent organ failure (lasting >48
 hours). Local complications include peripancreatic fluid collections, pancreatic and
 peripancreatic necrosis (sterile or infected), pseudocyst, and walled-offnecrosis (sterile or
 infected) .

 Prediabetes/Diabetes….Prediabetes is defined by fasting blood glucose (FBG ≥(100 mg/dL) and
 <(126 mg/dL),and/or 2 h oral glucose tolerance test (OGTT) criteria as >/ (140 mg/dL) and <
 (200 mg/dL)) or HbA1c of 5.7% to 6.4%. DM is defined as (FBG ≥ (126 mg/dL) or 2 hOGTT ≥ (200
 mg/dL)or HbA1c value>/ 6.5% ,treatment with insulin, oral hypoglycaemic agents or specific
 dietary management. Diagnosis of diabetes in asymptomatic patients is established by presence
 of abnormal test results in 2 out of 3 parameters used(FBG,OGTT or HbA1c) or if only one test
 result is abnormal ,needs to be confirmed on next day or few days later by repeat testing of
 the specific parameter.

 Study design :- Single center ,prospective cohort study performed at a tertiary care centre
 (Asian institute of gastroenterology , Hyderabad) from Feb 2019 to May 2020.

 Participant recruitment procedures…. Patient enrollment from Feb 2019 to May 2019 & follow up
 of each case upto 1 year, upto May 2020(1 year follow up).

 Primary outcome-Development of endocrine dysfunction (diabetes & prediabetes) after acute
 pancreatitis Secondary outcomes-Whether severity of acute pancreatitis correlate with
 development of diabetes & prediabetes.
METHODOLOGY: Patients of acute pancreatitis will be screened as per inclusion/exclusion
 criteria and patients with first episode of acute pancreatitis who meet the ATLANTA
 definition, will be graded for severity as per Modified Marshall criteria. Control group for
 the study will include nondiabetic /non prediabetic volunteers who come to OPD for master
 health check up or who are being suspected to have functional syndromes like functional
 dyspepsia or irritable bowel syndrome.The study will be a prospective cohort study in which
 initial recruitment will be for 4 months from Feb 2019 to May 2019, & recruited patients will
 be followed for a period of 1 year each from the period of recruitment, and as such the study
 is expected to complete by May 2020. On admission in addition to routine blood investigations
 , specific investigations for acute pancreatitis will be done(complete details in proforma)
 which include serum amylase ,serum lipase, USG abdomen, CECT abdomen(after 72hrs of onset of
 acute pancreatitis) will be done to assess for pancreatic necrosis. Blood sugar (fasting,
 postprandial) & HBA1c will be done on admission to evaluate the diabetic status of the
 patient. C peptide and Fasting insulin levels which will help assess the insulin resistance
 will be done at onset only in these patients .Control group will be assessed clinically and
 only clinically relevant investigations in addition to blood sugar (fasting, postprandial) &
 HBA1c will be done at initiation & at 6months & 1 year of follow up(follow up will be via
 telephonic communication or if possible in person) On follow up at 2months , 6months & 12
 months patients will be reassessed either in person (if possible) or via telephonic
 communication for endocrine dysfunction , which will be assessed by simple and routine tests
 as mentioned ( Blood sugar-fasting, postprandial & HbA1c).Controls will be clinically
 assessed and if clinically stable and asymptomatic will be assessed for diabetic status only
 with Blood sugar (fasting, postprandial) & HBA1c at initiation & subsequently at 6 months and
 1 year end.

 Statistical analysis :Data will be collected using a structured study proforma. Data will be
 put in MS EXCEL for further analysis .Results will be expressed as mean(SD), median (IQR) for
 continuous variables and percentage for categorical variables etc. Appropriate parametric and
 non parametric will be applied. SPSS (21st version) will be used for statistical analyses.

 Primary outcome…. To estimate incidence of endocrinopathy (diabetes & prediabetes)among Acute
 Pancreatitis patients.
Inclusion Criteria:

 1 )Ist episode of acute pancreatitis. 2) Non diabetic or non pre diabetic as per American
 Diabetes Association criteria .

 3) Age >18yrs.

 Exclusion Criteria:

 1. Acute pancreatitis cases who die within 1 month of hospitalization.

 2. Recurrent acute pancreatitis

 3. Chronic pancreatitis.

 4. Previous diagnosed diabetes or prediabetes

 5. Any malignancy

 6. Age <18yrs

 7. Pregnant females or lactating women.

 8. Chronic diarrhea, intestinal tuberculosis or Crohns disease