NCT04513197

Brief Summary

AIMS AND OBJECTIVES

  1. 1.To evaluate whether acute pancreatitis results in increased endocrine dysfunction or not?
  2. 2.To evaluate whether severity of acute pancreatitis have an impact on the development of endocrine dysfunction or not?

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2019

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2019

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2019

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

August 11, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 14, 2020

Completed
16 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2020

Completed
Last Updated

August 14, 2020

Status Verified

August 1, 2020

Enrollment Period

3 months

First QC Date

August 11, 2020

Last Update Submit

August 13, 2020

Conditions

Endocrine System Diseases

Outcome Measures

Primary Outcomes (1)

  • 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% ,

    1 year

Secondary Outcomes (1)

  • 2) To evaluate whether severity of acute pancreatitis have an impact on the development of endocrine dysfunction or not?

    72 hours

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Required sample size is 90 subjects with 80% power and 0.05 as type 1 error.

You may qualify if:

  • )Ist episode of acute pancreatitis. 2) Non diabetic or non pre diabetic as per American Diabetes Association criteria .
  • \) Age \>18yrs.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Asian Institute of Gastroenterology/AIG Hospitals

Hyderabad, Telangana, 500082, India

RECRUITING

MeSH Terms

Conditions

Endocrine System Diseases

Study Officials

  • Dr MANU TANDAN, MBBS MD DM

    Asian Institute of Gastroenterology, India

    PRINCIPAL INVESTIGATOR

Central Study Contacts

WAHID AKBAR LONE, MBBS MD

CONTACT

7006102770wahidakbar333@gmail.com

RAJESH GOUD MARAGONI, M.PHARM, MBA

CONTACT

9705053550rajeshgoud761@gmail.com

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

August 11, 2020

First Posted

August 14, 2020

Study Start

March 1, 2019

Primary Completion

May 31, 2019

Study Completion

August 30, 2020

Last Updated

August 14, 2020

Record last verified: 2020-08

Locations

IN(1)