Insulin ResistanceNCT00493259
Health Related QOL, Depression and Lifestyle Changes in Insulin Resistant Adolescents
An observational study of Insulin Resistance and Depression, run by Children's Mercy Hospital Kansas City at 1 site in United States.
Trial summary
The purpose of this study is to assess adolescents with Insulin Resistance Syndrome for quality of life and altered health related issues. Read more about this study
- Who is it for?
- Ages 11 to 17 years
- Conditions the study is for
- Insulin Resistance, Depression
- What is being tested?
- Health-Related Quality of Life instrument and Depression Scale for Children (CES-DC)
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 78 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2007to Jun 2008
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 11 to 17 years
- All sexes
- No healthy volunteers
- Child
Study population: Adoslescents treated in Children's Mercy Hospital and Clinic, Endocrine clinic.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Mercy Hospital
Kansas City, Missouri, 64108
About this study
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
The purpose of this study is to assess adolescents with Insulin Resistance Syndrome for quality of life and altered health related issues.
Read the 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.
- Conditions
- Insulin Resistance, Depression
- Being tested
- Health-Related Quality of Life instrument, Depression Scale for Children (CES-DC)
- Keywords
- Health-Related Quality of Life
- Medical subject headings
- Insulin Resistance, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Health-Related Quality of Life instrumentBehavioural
Adolescents will fill out questionnaires regarding quality of life and dealing with diagnosis of Insulin Resistance Syndrome
Depression Scale for Children (CES-DC)Behavioural
questionnaire
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2007 (estimated)
- Study startJun 2007
- Primary completionJun 2008
- Study completionJun 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Insulin ResistanceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Mercy Hospital Kansas City
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Adrienne Platt, MS, CPNP, Principal investigator, Children's Mercy Hospital Kansas City
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00493259
- Sponsor's protocol ID
- 07 02-037E
- Status last verified
- Jan 2021
- First submitted
- 26 Jun 2007
- Last updated
- 6 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00493259
- Acronym / sponsor ID
- 07 02-037E
- Conditions
- Insulin Resistance, Depression
- Keywords
- Health-Related Quality of Life
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Children's Mercy Hospital Kansas CityUniversity, hospital or other
- Study start
- Jun 2007 (actual)
- Primary completion
- Jun 2008 (actual)
- Study completion
- Jun 2008 (actual)
- First posted
- 28 Jun 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 11 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Adoslescents treated in Children's Mercy Hospital and Clinic, Endocrine clinic.
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Health-Related Quality of Life instrumentAdolescents will fill out questionnaires regarding quality of life and dealing with diagnosis of Insulin Resistance Syndrome | Behavioural | – |
| Depression Scale for Children (CES-DC)questionnaire | Behavioural | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Adrienne Platt, MS, CPNP principal investigator
Children's Mercy Hospital Kansas City
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Insulin Resistance and Depression, run by Children's Mercy Hospital Kansas City at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2021.