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NCT00493259 Clinical Trial

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

Depression Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00493259
Other study ID # 07 02-037E
Secondary ID
Status Completed
Phase
First received
Last updated
Start date June 2007
Est. completion date June 2008

Study information
Verified date January 2021
Source Children's Mercy Hospital Kansas City
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Completed
Enrollment 78
Est. completion date June 2008
Est. primary completion date June 2008
Accepts healthy volunteers No
Gender All
Age group 11 Years to 17 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Behavioral:
• Health-Related Quality of Life instrument
Adolescents will fill out questionnaires regarding quality of life and dealing with diagnosis of Insulin Resistance Syndrome
• Depression Scale for Children (CES-DC)
questionnaire

Locations
Country Name City State
United States Children's Mercy Hospital Kansas City Missouri

Sponsors (1)
Lead Sponsor Collaborator
Children's Mercy Hospital Kansas City

Country where clinical trial is conducted

United States, 

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