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

NCT ID: NCT00493259

Last Updated: 2021-01-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

78 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-06-30

Study Completion Date

2008-06-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Insulin Resistance Depression

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Interventions

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Health-Related Quality of Life instrument

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

Intervention Type BEHAVIORAL

Depression Scale for Children (CES-DC)

questionnaire

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

11 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Children's Mercy Hospital Kansas City

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Adrienne Platt, MS, CPNP

Role: PRINCIPAL_INVESTIGATOR

Children's Mercy Hospital Kansas City

Locations

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Children's Mercy Hospital

Kansas City, Missouri, United States

Site Status

Countries

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United States

Other Identifiers

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07 02-037E

Identifier Type: -

Identifier Source: org_study_id

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