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

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ClinicalTrials.gov Identifier: NCT00493259
Recruitment Status : Unknown
Verified June 2007 by Children's Mercy Hospital Kansas City.
Recruitment status was:  Recruiting
First Posted : June 28, 2007
Last Update Posted : January 23, 2008
Sponsor:
Information provided by:
Children's Mercy Hospital Kansas City

Tracking Information
First Submitted Date June 26, 2007
First Posted Date June 28, 2007
Last Update Posted Date January 23, 2008
Study Start Date June 2007
Estimated Primary Completion Date June 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures Not Provided
Original Primary Outcome Measures Not Provided
Change History Complete list of historical versions of study NCT00493259 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Health Related QOL, Depression and Lifestyle Changes in Insulin Resistant Adolescents
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
Brief Summary The purpose of this study is to assess adolescents with Insulin Resistance Syndrome for quality of life and altered health related issues.
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 Type Observational
Study Design Observational Model: Cohort
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Adoslescents treated in Children's Mercy Hospital and Clinic, Endocrine clinic.
Condition
  • Insulin Resistance
  • Depression
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
  • Behavioral: Depression Scale for Children (CES-DC)
    questionnaire
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: January¬†21,¬†2008)
100
Original Enrollment Not Provided
Estimated Study Completion Date June 2008
Estimated Primary Completion Date June 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: All
Ages 11 Years to 17 Years   (Child)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT00493259
Other Study ID Numbers 07 02-037E
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Adrienne Platt, MS, Cpnp, Children's Mercy Hospitals and Clinics
Study Sponsor Children's Mercy Hospital Kansas City
Collaborators Not Provided
Investigators
Principal Investigator: Adrienne Platt, MS, CPNP Children's Mercy Hospital Kansas City
PRS Account Children's Mercy Hospital Kansas City
Verification Date June 2007