Endocrine System DiseasesAPPDMNCT04513197
NEW ONSET ENDOCRINE DYSFUNCTION AFTER ACUTE PANCREATITIS
An observational study of Endocrine System Diseases, run by Asian Institute of Gastroenterology, India at 1 site in India.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Endocrine System Diseases
- How many people
- 90 participants
- Where
- 1 siteIndia
- Study dates
- 1 Mar 2019to 30 Aug 2020
- 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 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Required sample size is 90 subjects with 80% power and 0.05 as type 1 error.
Who may be able to join
- 1 )Ist episode of acute pancreatitis. 2) Non diabetic or non pre diabetic as per American Diabetes Association criteria .
- 3) Age >18yrs.
Who cannot join
- Acute pancreatitis cases who die within 1 month of hospitalization.
- Recurrent acute pancreatitis
- Chronic pancreatitis.
- Previous diagnosed diabetes or prediabetes
- Any malignancy
- Age <18yrs
- Pregnant females or lactating women.
- Chronic diarrhea, intestinal tuberculosis or Crohns disease
Trial locations and contacts
1 site in 1 country.
India1 site, 1 recruiting
- Recruiting
Asian Institute of Gastroenterology/AIG Hospitals
Hyderabad, Telangana, 500082
Dr Mohan Ramchandani, MBBS MD DM, 04023378888 ext. 802, ramchandanimohan@gmail.com
About this study
Official title: NEW ONSET ENDOCRINE DYSFUNCTION AFTER ACUTE PANCREATITIS(PANCREATICOGENIC DIABETES MILLETUS - TYPE 3C)
AIMS AND OBJECTIVES
- To evaluate whether acute pancreatitis results in increased endocrine dysfunction or not?
- To evaluate whether severity of acute pancreatitis have an impact on the development of endocrine dysfunction or not?
Read more
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.
Read the 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.
- Conditions
- Endocrine System Diseases
- Medical subject headings
- Endocrine System Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
Development of endocrine dysfunction (diabetes & prediabetes) after acute pancreatitis
Prediabetes/Diabetes is defined by fasting blood glucose (FBG ≥(100 mg/dL),HbA1c value>/ 6.5% ,
Measured: 1 year
Secondary outcomes (1)
2) To evaluate whether severity of acute pancreatitis have an impact on the development of endocrine dysfunction or not?
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.
Measured: 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2020
- Study start1 Mar 2019
- Primary completion31 May 2019
- Study completion30 Aug 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endocrine System DiseasesStudies of the same condition, open and under way.
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Asian Institute of Gastroenterology, India
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohan Ramchandani, Asian Institute of Gastroenterology, India
- Investigators
- Dr MANU TANDAN, MBBS MD DM, Principal investigator, Asian Institute of Gastroenterology, India
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04513197
- Sponsor's protocol ID
- NODAP
- Acronym
- APPDM
- Status last verified
- Aug 2020
- First submitted
- 11 Aug 2020
- Last updated
- 14 Aug 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- NEW ONSET ENDOCRINE DYSFUNCTION AFTER ACUTE PANCREATITIS(PANCREATICOGENIC DIABETES MILLETUS - TYPE 3C)
- ClinicalTrials.gov ID
- NCT04513197
- Acronym / sponsor ID
- APPDM / NODAP
- Conditions
- Endocrine System Diseases
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Asian Institute of Gastroenterology, IndiaUniversity, hospital or other
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 31 May 2019 (actual)
- Study completion
- 30 Aug 2020 (estimated)
- First posted
- 14 Aug 2020 (actual)
- 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.
AIMS AND OBJECTIVES
- To evaluate whether acute pancreatitis results in increased endocrine dysfunction or not?
- 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.
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
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Required sample size is 90 subjects with 80% power and 0.05 as type 1 error.
Key inclusion criteria (2 listed)
- 1 )Ist episode of acute pancreatitis. 2) Non diabetic or non pre diabetic as per American Diabetes Association criteria .
- 3) Age >18yrs.
Key exclusion criteria (8 listed)
- Acute pancreatitis cases who die within 1 month of hospitalization.
- Recurrent acute pancreatitis
- Chronic pancreatitis.
- Previous diagnosed diabetes or prediabetes
- Any malignancy
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
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% ,
1 secondary outcome
2) To evaluate whether severity of acute pancreatitis have an impact on the development of endocrine dysfunction or not?
Time frame: 72 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2020.
Related trials for Endocrine System Diseases
Not yet recruitingPhase 1/2
177Lu-DOTA-EB-TATE in Adult Patients With Metastatic, Radioactive Iodine Non-Responsive Oncocytic (Hurthle-Cell) Thyroid Cancer
Thyroid Cancer
Active, not recruitingPhase 1/2
A Beta-only IL-2 ImmunoTherapY Study
Advanced Solid Tumor, Unresectable Solid Tumor
RecruitingPhase 1
Study of Preoperative Radiation Therapy in Participants With Resectable Recurrent Abdominal Adrenocortical Carcinoma
Adrenocortical Carcinoma (ACC), Recurrent Adrenocortical Carcinoma (ACC)
RecruitingPhase 2
WoO: Window of Opportunity Trial of Olaparib and Durvalumab in Histologically Proven EOC
Epithelial Ovarian Cancer
RecruitingPhase 1
A Study of MGC030 in Participants With Advanced Solid Tumors
Urothelial Cancer, GastroEsophageal Cancer
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.
Dr MANU TANDAN, MBBS MD DM principal investigator
Asian Institute of Gastroenterology, India
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 Endocrine System Diseases, run by Asian Institute of Gastroenterology, India at 1 site in India.
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 2 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 14 Aug 2020. 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 India. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact WAHID AKBAR LONE, MBBS MD (7006102770, wahidakbar333@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Development of endocrine dysfunction (diabetes & prediabetes) after acute pancreatitis (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Aug 2020.