Health Related QOL, Depression and Lifestyle Changes in I... | NCT00493259

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

NCT00493259

Sponsor

Children's Mercy Hospital Kansas City

Status

Completed

Last Update Posted

Jan 6, 2021Actual

Enrollment

78Actual

Phase

Not provided

Conditions

Insulin Resistance
Depression

Interventions

Health-Related Quality of Life instrument
Depression Scale for Children (CES-DC)

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2007Actual

Primary Completion Date

Jun 2008Actual

Completion Date

Jun 2008Actual

First Submitted Date

Jun 26, 2007

First Submission Date that Met QC Criteria

Jun 27, 2007

First Posted Date

Jun 28, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 5, 2021

Last Update Posted Date

Jan 6, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

78Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Health-Related Quality of Life instrument	Behavioral	Adolescents will fill out questionnaires regarding quality of life and dealing with diagnosis of Insulin Resistance Syndrome
Depression Scale for Children (CES-DC)	Behavioral	questionnaire

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

11 Years

Maximum Age

17 Years

Standard Ages

Child

Study Population

Adoslescents treated in Children's Mercy Hospital and Clinic, Endocrine clinic.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Adrienne Platt, MS, CPNP	Children's Mercy Hospital Kansas City	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Children's Mercy Hospital		Kansas City	Missouri	64108	United States

Condition Browse Module

MeSH Terms

ID	Term
D007333	Insulin Resistance
D003863	Depression

Ancestor Terms

ID	Term
D006946	Hyperinsulinism
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided