- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00493259
Health Related QOL, Depression and Lifestyle Changes in Insulin Resistant Adolescents
January 5, 2021 updated by: Children's Mercy Hospital Kansas City
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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
Enrollment (Actual)
78
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Missouri
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Kansas City, Missouri, United States, 64108
- Children's Mercy Hospital
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
11 years to 17 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Adoslescents treated in Children's Mercy Hospital and Clinic, Endocrine clinic.
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Adrienne Platt, MS, CPNP, Children's Mercy Hospital Kansas City
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 1, 2007
Primary Completion (Actual)
June 1, 2008
Study Completion (Actual)
June 1, 2008
Study Registration Dates
First Submitted
June 26, 2007
First Submitted That Met QC Criteria
June 27, 2007
First Posted (Estimate)
June 28, 2007
Study Record Updates
Last Update Posted (Actual)
January 6, 2021
Last Update Submitted That Met QC Criteria
January 5, 2021
Last Verified
January 1, 2021
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 07 02-037E
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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