| CTRI Number |
CTRI/2025/02/080396 [Registered on: 12/02/2025] Trial Registered Prospectively |
| Last Modified On: |
31/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Understanding Diabetes in pancreatitis and its long term impct |
|
Scientific Title of Study
|
Diagnostic Models Of Diabetes Mellitus In Idiopathic Recurrent Chronic Pancreatitis Or Early Chronic Pancreatitis To Be Distinguished From Type 2 Diabetes Mellitus- Long Term Follow-Up |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Rajiv Mehta |
| Designation |
Consultant Gastroenterologist |
| Affiliation |
SIDS hospital and research centre |
| Address |
SIDS healthcare private limited Majura-Khatodara Bamroli road Khatodara Near Shell petrol pump Majuragate, Department of Gastroenterology, Room no 5003
Surat
GUJARAT
395002
India |
| Phone |
9909907475 |
| Fax |
|
| Email |
rmgastro@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sankalp Parikh |
| Designation |
DrNB student |
| Affiliation |
SIDS hospital and research centre |
| Address |
SIDS healthcare private limited Majura-Khatodara Bamroli road Khatodara Near Shell petrol pump Majuragate, Department of Gastroenterology, Room no 5003
Surat
GUJARAT
395002
India |
| Phone |
7861828719 |
| Fax |
|
| Email |
sankalpparikh@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Dhvani Adhvaryu |
| Designation |
Research Coordinator |
| Affiliation |
SIDS hospital and research centre |
| Address |
SIDS healthcare private limited Majura-Khatodara Bamroli road Khatodara Near Shell petrol pump Majuragate, Department of Gastroenterology, Room no 5003
Surat
GUJARAT
395002
India |
| Phone |
9925849900 |
| Fax |
|
| Email |
dhvaniadhvaryu21@gmail.com |
|
|
Source of Monetary or Material Support
|
| SIDS Hospital and Research Centre |
|
|
Primary Sponsor
|
| Name |
SIDS Hospital and Research Center |
| Address |
SIDS healthcare private limited Majura-Khatodara Bamroli road Khatodara Near Shell petrol pump Majuragate, Surat, Gujarat, 395002 |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Sankalp Parikh |
SIDS Hospital and Research Center |
Room no 5003, 5th floor,division of GI research,
SIDS healthcare private limited Majura Khatodara Bamroli road
Near Shell petrol pump Majura gate
Surat
GUJARAT |
7861828719
sankalpparikh@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SIDS Hospital and Research Centre EC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K861||Other chronic pancreatitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Adults aged 18 years and above diagnosed with IRCP or ECP, confirmed by clinical, biochemical, and imaging findings.
2. Patients who demonstrate evidence of pancreatic dysfunction, including exocrine insufficiency (e.g., low fecal elastase) or endocrine dysfunction (e.g., impaired glucose tolerance).
3. Patients capable of adhering to study protocols and attending follow-up assessments.
4. Willingness to provide informed consent for participation and data use.
|
|
| ExclusionCriteria |
| Details |
1. Patients with secondary causes of pancreatitis, including alcohol-induced, biliary, or hereditary pancreatitis.
2. Patients with pre-existing diabetes unrelated to pancreatitis (e.g., Type 1 or Type 2 diabetes diagnosed before pancreatitis onset).
3. Those with severe systemic illnesses or comorbidities, such as advanced malignancies or end-stage organ failure, that could interfere with study adherence.
4. Pregnant or breastfeeding women, to avoid confounding physiological changes.
5. Patients on medications known to affect pancreatic function, such as corticosteroids or chronic opioid therapy
|
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To elucidate the distinct clinical characteristics and management challenges of DM3c in CP, differentiating it from DM2 |
Outcome will be measured at the baseline (One time point study) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Diagnostic criteria
2.Better understanding of the pathophysiology
3.Enhanced treatment strategies for DM3c, ultimately leading to improved patient care and quality of life.
|
Outcome will be measured at the baseline (One time point study) |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
20/02/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This observational cohort study (prospective and retrospective) aims to analyze the phenotype and prevalence of diabetes mellitus in patients with idiopathic recurrent chronic pancreatitis (IRCP) or early chronic pancreatitis (ECP). It will assess the severity of diabetes in relation to pancreatitis, evaluate pancreatic dysfunction, and compare diagnostic models for differentiating Type 3c Diabetes Mellitus (T3cDM) from Type 2 Diabetes Mellitus (T2DM). The study will enroll 70 patients, including a 10% dropout rate, meeting inclusion criteria. The study involves detailed clinical evaluation, structured interviews, physical examinations, Imaging techniques and Functional pancreatic assessments. Patients will undergo standardized glucose tolerance assessments, antibody evaluation and insulin response to differentiate phenotype of diabetes mellitus. |