NCT00841867

Brief Summary

The purpose of this study is to examine changes in sugar metabolism that may occur in subjects who have previously had part of their pancreas removed due to a benign lesion.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
24

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Dec 2008

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

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

December 1, 2008

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 10, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 11, 2009

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2009

Completed
Last Updated

November 17, 2016

Status Verified

November 1, 2016

Enrollment Period

10 months

First QC Date

February 10, 2009

Last Update Submit

November 16, 2016

Conditions

Impaired Glucose Tolerance

Keywords

Impaired Glucose ToleranceDiabetes

Outcome Measures

Primary Outcomes (1)

  • To determine differences in glucose metabolism between subjects who have had partial pancreatectomy due to a benign lesion and those who have not had such a surgery.

    Outcome will be determined after all data has been collected.

Study Arms (2)

1

Subjects 18-80 years of age who have previously undergone partial pancreatectomy due to a benign lesion

Procedure: All subjects will undergo a 120 minute Oral Glucose Tolerance Test at study visit 2.

2

Healthy control subjects, 18-80 years of age, who have not had partial pancreatectomy.

Procedure: All subjects will undergo a 120 minute Oral Glucose Tolerance Test at study visit 2.

Interventions

All subjects will undergo a 120 minute Oral Glucose Tolerance Test at study visit 2.PROCEDURE

All subjects will ingest a 75 g glucose solution (Glucola brand) and have blood drawn at 7 timepoints over 120 minutes.

12

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Subjects 18-80 years of age who have had partial pancreatectomy for benign lesions and healthy controls who have not had pancreas surgery.

You may qualify if:

  • Male and Female subjects
  • years of age who have had
  • partial pancreatectomy due to a benign lesion
  • OR are healthy control subjects
  • are willing to fast (nothing to eat or drink for 10 hours)prior to visits

You may not qualify if:

  • Pancreatic malignancy
  • Chronic pancreatitis
  • Pregnant
  • On steroid medications such as prednisone

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UCLA General Clinical Research Center (GCRC)

Los Angeles, California, 90024, United States

Location

MeSH Terms

Conditions

Glucose IntoleranceDiabetes Mellitus

Condition Hierarchy (Ancestors)

HyperglycemiaGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 10, 2009

First Posted

February 11, 2009

Study Start

December 1, 2008

Primary Completion

October 1, 2009

Study Completion

October 1, 2009

Last Updated

November 17, 2016

Record last verified: 2016-11

Locations

US(1)