MedTrace Logo

NEW ONSET ENDOCRINE DYSFUNCTION AFTER ACUTE PANCREATITIS

NCT04513197 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 90

Last updated 2020-08-14

No results posted yet for this study

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.

Conditions

  • Endocrine System Diseases

Sponsors & Collaborators

  • Asian Institute of Gastroenterology, India

    lead OTHER

Principal Investigators

  • Dr MANU TANDAN, MBBS MD DM · Asian Institute of Gastroenterology, India

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-03-01
Primary Completion
2019-05-31
Completion
2020-08-30

Countries

  • India

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04513197 on ClinicalTrials.gov