Ignite Creation Date:
2024-05-06 @ 3:05 PM
Last Modification Date:
2025-12-17 @ 6:53 AM
Study NCT ID:
NCT04513197
Status:
None
Last Update Posted:
2020-08-14 00:00:00
First Post:
2020-08-11 00:00:00
Brief Title:
NEW ONSET ENDOCRINE DYSFUNCTION AFTER ACUTE PANCREATITIS
Sponsor:
Asian Institute of Gastroenterology India
Organization:
Asian Institute of Gastroenterology, India
Study Overview
Official Title:
NEW ONSET ENDOCRINE DYSFUNCTION AFTER ACUTE PANCREATITIS(PANCREATICOGENIC DIABETES MILLETUS - TYPE 3C)
Status:
None
Status Verified Date:
2020-08
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
APPDM
Brief Summary:
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.
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.
Detailed Description:
METHODOLOGY Patients of acute pancreatitis will be screened as per inclusionexclusion 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 syndromeThe 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 donecomplete details in proforma which include serum amylase serum lipase USG abdomen CECT abdomenafter 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 upfollow 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 HbA1cControls 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 meanSD 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 prediabetesamong Acute Pancreatitis patients
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 meanSD 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 prediabetesamong Acute Pancreatitis patients
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None