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Health Related QOL, Depression and Lifestyle Changes in Insulin Resistant Adolescents

Sponsor
Children's Mercy Hospital Kansas City (Other)
Overall Status
Completed
CT.gov ID
NCT00493259
Collaborator
(none)
78
Enrollment
1
Location
12
Actual Duration (Months)
6.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Health-Related Quality of Life instrument
  • Behavioral: Depression Scale for Children (CES-DC)

Detailed Description

Matched historical control study designed to examine outcomes on insulin resistant adolescents who were treated in the Insulin Resistance Syndrome Clinic at Children's Mercy Hospital in the past year. New patients will be screened at baseline, 4 and 12 months to evaluate if there is improvement in the BMI Z-score, HgA1c, lipid profile or waist circumference when depression and/or altered health related quality of life are identified and treated in this population.

Study Design

Study Type:
Observational
Actual Enrollment :
78 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
Health-related Quality of Life, Depression and the Impact on Successful Incorporation of Lifestyle Changes in Insulin Resistant Adolescents as Evidenced by Changes in BMI, Waist Circumference and Metabolic Parameters
Actual Study Start Date :
Jun 1, 2007
Actual Primary Completion Date :
Jun 1, 2008
Actual Study Completion Date :
Jun 1, 2008

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    11 Years to 17 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • 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

    Exclusion Criteria:

    • 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Children's Mercy Hospital Kansas City Missouri United States 64108

    Sponsors and Collaborators

    • Children's Mercy Hospital Kansas City

    Investigators

    • Principal Investigator: Adrienne Platt, MS, CPNP, Children's Mercy Hospital Kansas City

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Children's Mercy Hospital Kansas City
    ClinicalTrials.gov Identifier:
    NCT00493259
    Other Study ID Numbers:
    • 07 02-037E
    First Posted:
    Jun 28, 2007
    Last Update Posted:
    Jan 6, 2021
    Last Verified:
    Jan 1, 2021
    Keywords provided by Children's Mercy Hospital Kansas City
    Health-Related Quality of Life
    Additional relevant MeSH terms:
    Insulin Resistance
    Depression
    Depressive Disorder

    Study Results

    No Results Posted as of Jan 6, 2021