NCT04409171

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

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

Enrollment
224

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2015

Longer than P75 for all trials

Status
completed

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

September 1, 2015

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2018

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2020

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

May 26, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 1, 2020

Completed
Last Updated

June 1, 2020

Status Verified

May 1, 2020

Enrollment Period

3.3 years

First QC Date

May 26, 2020

Last Update Submit

May 26, 2020

Conditions

Keywords

PancreatectomyDiabetes Mellituspancreaticoduodenectomy

Outcome Measures

Primary Outcomes (2)

  • incidence & risk factors of new-onset DM

    incidence \& risk factors of new onset DM after pancreatectomy

    at 1 year

  • incidence & risk factors of worsened DM

    incidence \& risk factors of worsened DM after pancreatectomy

    at 1 year

Secondary Outcomes (1)

  • characteristics of new-onset and worsened DM

    1 year

Study Arms (2)

PD

pancreaticoduodenectomy

Diagnostic Test: oral glucose tolerance test

DP

distal pancreatectomy

Diagnostic Test: oral glucose tolerance test

Interventions

DPPD

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients receiving partial pancreatectomy

You may qualify if:

  • partial pancreatectomy

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • Lee BW, Kang HW, Heo JS, Choi SH, Kim SY, Min YK, Chung JH, Lee MK, Lee MS, Kim KW. Insulin secretory defect plays a major role in the development of diabetes in patients with distal pancreatectomy. Metabolism. 2006 Jan;55(1):135-41. doi: 10.1016/j.metabol.2005.08.005.

    PMID: 16324932BACKGROUND
  • Hwang HK, Park J, Choi SH, Kang CM, Lee WJ. Predicting new-onset diabetes after minimally invasive subtotal distal pancreatectomy in benign and borderline malignant lesions of the pancreas. Medicine (Baltimore). 2017 Dec;96(51):e9404. doi: 10.1097/MD.0000000000009404.

    PMID: 29390555BACKGROUND

MeSH Terms

Conditions

HyperglycemiaDiabetes Mellitus

Interventions

Glucose Tolerance Test

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Blood Chemical AnalysisClinical Chemistry TestsClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisDiagnostic Techniques, EndocrineInvestigative Techniques

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Year
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

May 26, 2020

First Posted

June 1, 2020

Study Start

September 1, 2015

Primary Completion

December 31, 2018

Study Completion

January 31, 2020

Last Updated

June 1, 2020

Record last verified: 2020-05

Data Sharing

IPD Sharing
Will not share

There are no plans of sharing IPD