NEW ONSET ENDOCRINE DYSFUNCTION AFTER ACUTE PANCREATITIS (APPDM)

• ClinicalTrials.gov Identifier: NCT04513197
• Recruitment Status: Recruiting
• First Posted: August 14, 2020
• Last Update Posted: August 14, 2020
• Sponsor: Asian Institute of Gastroenterology, India
• Information provided by (Responsible Party): Mohan Ramchandani, Asian Institute of Gastroenterology, India

Study Description

Brief Summary:

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.

Condition or disease
Endocrine System Diseases

Detailed Description:

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.

Study Design

• Study Type: Observational
• Estimated Enrollment: 90 participants
• Observational Model: Case-Control
• Time Perspective: Prospective
• Official Title: NEW ONSET ENDOCRINE DYSFUNCTION AFTER ACUTE PANCREATITIS(PANCREATICOGENIC DIABETES MILLETUS - TYPE 3C)
• Actual Study Start Date: March 1, 2019
• Actual Primary Completion Date: May 31, 2019
• Estimated Study Completion Date: August 30, 2020

Groups and Cohorts

Outcome Measures

Primary Outcome Measures :

1. Development of endocrine dysfunction (diabetes & prediabetes) after acute pancreatitis [ Time Frame: 1 year ]
   Prediabetes/Diabetes is defined by fasting blood glucose (FBG ≥(100 mg/dL),HbA1c value>/ 6.5% ,

Secondary Outcome Measures :

1. 2) To evaluate whether severity of acute pancreatitis have an impact on the development of endocrine dysfunction or not? [ Time Frame: 72 hours ]
   Severity of acute pancreatitis can be done based on elevated serum amylase and lipase levels.normal range of amylase level is( 28-100 units U/I) more than 3 times of normal range indicated acute pancreatitis, normal range of lipase is (5.6-51.3) more than 3 times of normal range leads to acute pancreatitis.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 70 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes
• Sampling Method: Probability Sample

Study Population

Required sample size is 90 subjects with 80% power and 0.05 as type 1 error.

Criteria

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

Contacts and Locations

Contacts

Contact: WAHID AKBAR LONE, MBBS MD; 7006102770; wahidakbar333@gmail.com

Contact: RAJESH GOUD MARAGONI, M.PHARM, MBA; 9705053550; rajeshgoud761@gmail.com

Locations

India

Asian Institute of Gastroenterology/AIG Hospitals; Recruiting

Hyderabad, Telangana, India, 500082

Contact: Dr Mohan Ramchandani, MBBS MD DM 04023378888 ext 802 ramchandanimohan@gmail.com

Sponsors and Collaborators

Asian Institute of Gastroenterology, India

Investigators

• Principal Investigator: Dr MANU TANDAN, MBBS MD DM; Asian Institute of Gastroenterology, India

More Information

• Responsible Party: Mohan Ramchandani, Dr, Asian Institute of Gastroenterology, India
• ClinicalTrials.gov Identifier: NCT04513197
• Other Study ID Numbers: NODAP
• First Posted: August 14, 2020
• Last Update Posted: August 14, 2020
• Last Verified: August 2020

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Pancreatitis; Endocrine System Diseases; Pancreatic Diseases; Digestive System Diseases