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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
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
  Purpose
The purpose of this study is to assess adolescents with Insulin Resistance Syndrome for quality of life and altered health related issues.

Condition Intervention
Insulin Resistance
Depression
Behavioral: Health-Related Quality of Life instrument
Behavioral: Depression Scale for Children (CES-DC)

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Children's Mercy Hospital Kansas City:

Estimated Enrollment: 100
Study Start Date: June 2007
Estimated Study Completion Date: June 2008
Estimated Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    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
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.
  Eligibility

Ages Eligible for Study:   11 Years to 17 Years   (Child)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adoslescents treated in Children's Mercy Hospital and Clinic, Endocrine clinic.
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00493259

Locations
United States, Missouri
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
  More Information

Responsible Party: Adrienne Platt, MS, Cpnp, Children's Mercy Hospitals and Clinics
ClinicalTrials.gov Identifier: NCT00493259     History of Changes
Other Study ID Numbers: 07 02-037E 
Study First Received: June 26, 2007
Last Updated: January 21, 2008
Health Authority: United States: Institutional Review Board

Keywords provided by Children's Mercy Hospital Kansas City:
Health-Related Quality of Life

Additional relevant MeSH terms:
Depression
Depressive Disorder
Insulin Resistance
Behavioral Symptoms
Mood Disorders
Mental Disorders
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on December 05, 2016