NCT00493259

Brief Summary

The purpose of this study is to assess adolescents with Insulin Resistance Syndrome for quality of life and altered health related issues.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
78

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2007

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

June 1, 2007

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

June 26, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 28, 2007

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2008

Completed
Last Updated

January 6, 2021

Status Verified

January 1, 2021

Enrollment Period

1 year

First QC Date

June 26, 2007

Last Update Submit

January 5, 2021

Conditions

Keywords

Health-Related Quality of Life

Interventions

Adolescents will fill out questionnaires regarding quality of life and dealing with diagnosis of Insulin Resistance Syndrome

Eligibility Criteria

Age11 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Adoslescents treated in Children's Mercy Hospital and Clinic, Endocrine clinic.

You may qualify if:

  • Patients 11-17 years of age who are seen in the Insulin Resistance Clinic for the first time
  • Historical control: Patients 11-19 years of age seen in the Insulin Resistance Clinic during the prior four months

You may not qualify if:

  • Co-morbid syndrome (Downs, Turner's, Prader Willi etc)
  • Diagnosis of Type 2 Diabetes
  • Taking Metformin before the initial visit
  • Taking medication for or diagnosis of a psychiatric condition prior to initial visit
  • Developmentally delayed

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Mercy Hospital

Kansas City, Missouri, 64108, United States

Location

MeSH Terms

Conditions

Insulin ResistanceDepression

Condition Hierarchy (Ancestors)

HyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesBehavioral SymptomsBehavior

Study Officials

  • Adrienne Platt, MS, CPNP

    Children's Mercy Hospital Kansas City

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 26, 2007

First Posted

June 28, 2007

Study Start

June 1, 2007

Primary Completion

June 1, 2008

Study Completion

June 1, 2008

Last Updated

January 6, 2021

Record last verified: 2021-01

Locations