- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01470885
Relation of Glucose and Acute Pancreatitis (ROGAAP)
May 2, 2014 updated by: xiaolong zhao, Huashan Hospital
the Influence of Glucose to the Prognosis of Patients of Acute Pancreatitis
Acute pancreatitis (AP) is an acute inflammatory disease of the pancreas which can lead to a systemic inflammatory response syndrome with significant morbidity and mortality in 20% of patients.
Part of endocrine function of pancreas would be affected in AP.
Stress hyperglycemia would explode at acute phase.
So the investigators decide to follow up and observe 200 cases of patients with acute pancreatitis, determining of blood sugar, blood amylase, hemoglobin and glycosylated hemoglobin level.
At last, using ROC curve method to identify the die cutting between blood glucose level and acute pancreatitis, and makes analysis of the diagnostic value.
Study Overview
Status
Completed
Conditions
Detailed Description
Acute pancreatitis (AP) is an acute inflammatory disease of the pancreas which can lead to a systemic inflammatory response syndrome with significant morbidity and mortality in 20% of patients.
Part of endocrine function of pancreas would be affected in AP.
Stress hyperglycemia would explode at acute phase.
There are two reasons.
One is because that sympathetic hyperactivity makes glucagon elevated.
Secondary, microcirculation disorder makes pancreas edema, ischemia and necrosis, affecting secretion and excretion of insulin.
In severe acute pancreatitis, there may be ketoacidosis.
Many scoring systems for predicting prognosis of severe acute pancreatitis also contains glucose values, such as the Ranson scoring system and the Glascow scoring system.
On the other hand, Type 2 diabetes has become a global pandemic disease.
Most of patients of type 2 diabetes are obese, who easily complicated gallstone disease and hypertriglyceridemia.
All of above could be the risk factors for acute pancreatitis.
Our initial small sample research also suggests undiagnosed diabetes patients whose glucose value elevated is significantly worse than the known diabetic patients.
Therefore, the investigators believe that glucose directly affects the prognosis of AP.
So the investigators decide to follow up and observe 1000 cases of patients with acute pancreatitis, determining of blood sugar, blood amylase, hemoglobin and glycosylated hemoglobin level.
At last, using ROC curve method to identify the die cutting between blood glucose level and acute pancreatitis, and makes analysis of the diagnostic value.
Study Type
Observational
Enrollment (Actual)
350
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Shanghai
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Shanghai, Shanghai, China, 21012
- Xiaolong Zhao
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
13 years to 83 years (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
primary care clinic
Description
Inclusion Criteria:
patients that newly diagnosed as acute pancreatitis.
Exclusion Criteria:
exclude other acute abdomen, such as peptic ulcer with perforation, mesenteric arterial embolism or ruptured ectopic pregnancy.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
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glucose value
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
motability
Time Frame: motability
|
motability after acute pancreatitis
|
motability
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2011
Primary Completion (Actual)
December 1, 2011
Study Completion (Actual)
December 1, 2011
Study Registration Dates
First Submitted
November 9, 2011
First Submitted That Met QC Criteria
November 10, 2011
First Posted (Estimate)
November 11, 2011
Study Record Updates
Last Update Posted (Estimate)
May 5, 2014
Last Update Submitted That Met QC Criteria
May 2, 2014
Last Verified
May 1, 2014
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- zsdxxhnk20110707
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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