Acute PancreatitisROGAAPNCT01470885
Relation of Glucose and Acute Pancreatitis
An observational study of Acute Pancreatitis, run by Huashan Hospital at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 15 to 85 years
- Conditions the study is for
- Acute Pancreatitis
- How many people
- 350 participants
- Where
- 1 siteChina
- Study dates
- Mar 2011to Dec 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 85 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: primary care clinic
Who may be able to join
- patients that newly diagnosed as acute pancreatitis.
Who cannot join
- exclude other acute abdomen, such as peptic ulcer with perforation, mesenteric arterial embolism or ruptured ectopic pregnancy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Acute Pancreatitis
- Keywords
- glucose, prognosis, glycated hemoglobin
- Medical subject headings
- Pancreatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| glucose value | glucose value |
What is being measured
The primary outcome is the main question the study is designed to answer.
motability
motability after acute pancreatitis
Measured: motability
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2011 (estimated)
- Study startMar 2011
- Primary completionDec 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute PancreatitisStudies of the same condition, open and under way.
- More trials run by Huashan HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 350 participants (actual)
Sponsor and investigators
- Lead sponsor
- Huashan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, xiaolong zhao, Huashan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01470885
- Sponsor's protocol ID
- zsdxxhnk20110707
- Acronym
- ROGAAP
- Status last verified
- May 2014
- First submitted
- 9 Nov 2011
- Last updated
- 5 May 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Zhao X, Chang Mei H, Chen L, Jiang L, He M, Chen J, Hu Z, Ye H, Hu H, Zhou L, Li Y, Hu R. An increased level of haemoglobin A1C predicts a poorer clinical outcome in patients with acute pancreatitis. Clin Endocrinol (Oxf). 2012 Aug;77(2):241-5. doi: 10.1111/j.1365-2265.2011.04252.x.
PubMed 21988175
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- the Influence of Glucose to the Prognosis of Patients of Acute Pancreatitis
- ClinicalTrials.gov ID
- NCT01470885
- Acronym / sponsor ID
- ROGAAP / zsdxxhnk20110707
- Conditions
- Acute Pancreatitis
- Keywords
- glucose, prognosis, glycated hemoglobin
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 350 participants (actual)
- Lead sponsor
- Huashan HospitalUniversity, hospital or other
- Collaborators
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
- Study start
- Mar 2011
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 11 Nov 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| glucose value | – | –glucose value |
Who may qualify
- Ages
- 15 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- primary care clinic
Key inclusion criteria (1 listed)
- patients that newly diagnosed as acute pancreatitis.
Key exclusion criteria (1 listed)
- exclude other acute abdomen, such as peptic ulcer with perforation, mesenteric arterial embolism or ruptured ectopic pregnancy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
motability
Time frame: motability
motability after acute pancreatitis
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2014.
- Results publication: PubMed 21988175Zhao X, Chang Mei H, Chen L, Jiang L, He M, Chen J, Hu Z, Ye H, Hu H, Zhou L, Li Y, Hu R. An increased level of haemoglobin A1C predicts a poorer clinical outcome in patients with acute pancreatitis. Clin Endocrinol (Oxf). 2012 Aug;77(2):241-5. doi: 10.1111/j.1365-2265.2011.04252.x.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Pancreatitis, run by Huashan Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
motability (time frame: motability). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01470885, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2014.