NCT00287456

Brief Summary

We hypothesize use of the insulin pump will improve body weight, lean body mass, whole body protein turnover, hepatic glucose production (HGP), and blood sugar control in CF patients with impaired glucose tolerance or patients with CF related diabetes (CFRD). We further hypothesize that HGP is also elevated in children/adolescents with type 1 diabetes and that the insulin pump will result in decreased HGP.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Feb 2006

Geographic Reach
1 country

1 active site

Status
withdrawn

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 2, 2006

Completed
Same day until next milestone

Study Start

First participant enrolled

February 2, 2006

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 2, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 2, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 6, 2006

Completed
Last Updated

January 10, 2019

Status Verified

January 1, 2019

Enrollment Period

Same day

First QC Date

February 2, 2006

Last Update Submit

January 8, 2019

Conditions

Cystic Fibrosis Related Diabetes

Interventions

Insulin PumpDEVICE
InsulinDRUG

0

Also known as: 0
Oral Glucose Tolerance TestPROCEDURE

0

Whole body Protein TurnoverPROCEDURE

0

Eligibility Criteria

Age12 Years - 32 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Cystic fibrosis patients aged 12-32 years
  • Impaired glucose tolerance or CFRD defined as fasting blood glucose (FBG) and post-prandial blood glucose (pp) equal to: FBG \<126 and pp 151-200, or FBG \<126 and pp \>200, or FBG \>126 and pp \>200.
  • Type 1 diabetes control patients aged 12-32 years.

You may not qualify if:

  • Colonization with Burkholderia cepacia
  • currently on corticosteroid medication
  • pregnant
  • medically unstable
  • Unable to understand the insulin pump directions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Medical Center of Dallas

Dallas, Texas, 75390, United States

Location

MeSH Terms

Interventions

Insulin Infusion SystemsInsulinGlucose Tolerance Test

Intervention Hierarchy (Ancestors)

Drug Delivery SystemsDrug TherapyTherapeuticsInfusion PumpsEquipment and SuppliesArtificial OrgansSurgical EquipmentProinsulinInsulinsPancreatic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and ProteinsBlood Chemical AnalysisClinical Chemistry TestsClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisDiagnostic Techniques, EndocrineInvestigative Techniques

Study Officials

  • Dana S Hardin, MD

    University of Texas, Southwestern Medical Center at Dallas

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 2, 2006

First Posted

February 6, 2006

Study Start

February 2, 2006

Primary Completion

February 2, 2006

Study Completion

February 2, 2006

Last Updated

January 10, 2019

Record last verified: 2019-01

Locations

US(1)