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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2007 by Children's Mercy Hospital Kansas City.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Children's Mercy Hospital Kansas City
ClinicalTrials.gov Identifier:
NCT00493259
First received: June 26, 2007
Last updated: January 21, 2008
Last verified: June 2007
History of Changes

June 26, 2007
January 21, 2008
June 2007
June 2008   (final data collection date for primary outcome measure)
 
 
Complete list of historical versions of study NCT00493259 on ClinicalTrials.gov Archive Site
 
 
 
 
 
Health Related QOL, Depression and Lifestyle Changes in Insulin Resistant Adolescents
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

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

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.
Observational
Observational Model: Cohort
Time Perspective: Retrospective
 
Non-Probability Sample

Adoslescents treated in Children's Mercy Hospital and Clinic, Endocrine clinic.
  • Insulin Resistance
  • Depression
  • 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
 
 

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
100
June 2008
June 2008   (final data collection date for primary outcome measure)

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
Both
11 Years to 17 Years
No
Contact: Adrienne Platt, MS, CPNP 813-234-3804 aplatte@cmh.edu
United States
 
NCT00493259
07 02-037E
No
Adrienne Platt, MS, Cpnp, Children's Mercy Hospitals and Clinics
Children's Mercy Hospital Kansas City
 
Principal Investigator: Adrienne Platt, MS, CPNP Children's Mercy Hospital
Children's Mercy Hospital Kansas City
June 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP