Glucose Metabolism After Partial Pancreatectomy

May 26, 2020 updated by: Yoo-Seok Yoon, Seoul National University Hospital

Alteration of Glucose Metabolism After Partial Pancreatectomy Assessed With Biochemical Markers :A Single Center Prospective Observational Study

This is a single center observational study to assess alteration of glucose metabolism after pancreatectomy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Biochemical markers of glucose metabolism including oral glucose tolerance tests, fasting blood glucose, insulin, glucagon and HbA1c were performed on patients receiving pancreatectomy (pancreaticoduodenectomy and distal pancreatectomy). Tests were done preoperatively, postoperatively at 3 months, and at 1 year. The primary endpoints were the incidence and risk factors of new-onset and worsened DM after each type of pancreatectomy.

Study Type

Observational

Enrollment (Actual)

224

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

patients receiving partial pancreatectomy

Description

Inclusion Criteria:

  • partial pancreatectomy

Exclusion Criteria:

  • total pancreatectomy
  • incomplete testing
  • follow-up loss
  • death within 1 year

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
Intervention / Treatment
PD
pancreaticoduodenectomy
Diagnostic test: oral glucose tolerance test
DP
distal pancreatectomy
Diagnostic test: oral glucose tolerance test

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
incidence & risk factors of new-onset DM
Time Frame: at 1 year
incidence & risk factors of new onset DM after pancreatectomy
at 1 year
incidence & risk factors of worsened DM
Time Frame: at 1 year
incidence & risk factors of worsened DM after pancreatectomy
at 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
characteristics of new-onset and worsened DM
Time Frame: 1 year
changes of glucose metabolism during study period
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

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.

General Publications

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 (Actual)

September 1, 2015

Primary Completion (Actual)

December 31, 2018

Study Completion (Actual)

January 31, 2020

Study Registration Dates

First Submitted

May 26, 2020

First Submitted That Met QC Criteria

May 26, 2020

First Posted (Actual)

June 1, 2020

Study Record Updates

Last Update Posted (Actual)

June 1, 2020

Last Update Submitted That Met QC Criteria

May 26, 2020

Last Verified

May 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SNUBH-GS-HBP6

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

There are no plans of sharing IPD

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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.

Clinical Trials on Diabete Mellitus

Clinical Trials on oral glucose tolerance test

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Serbia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe