Eating DisorderNCT00945711
Characteristics of Persons With an Eating Disorder and Type 1 Diabetes
An observational study of Eating Disorder and Type 1 Diabetes, run by HealthPartners Institute at 1 site in United States.
Trial summary
The purpose of this study is to analyze a chart audit of patients seen at Park Nicollet Eating Disorder Institute (EDI) to identify and compare general characteristics of eating disorders with type 1 diabetes patients to a matched eating disordered population without type 1 diabetes, also seen at EDI. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Eating Disorder, Type 1 Diabetes
- How many people
- 154 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2010to Sep 2010
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Park Nicollet Eating Disorder Institute patient and International Diabetes Center type 1 diabetes patients
Who may be able to join
- patient seen in both Park Nicollet Eating Disorder Institute and International Diabetes Center for type 1 diabetes from 2005 - 2008
- patient seen only in Park Nicollet Eating Disorder Institute from 2005 - 2008
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
United States1 site
International Diabetes Center
Minneapolis, Minnesota, 55416
About this study
Official title: Characteristics of Persons With an Eating Disorder and Type 1 Diabetes and Psychological Comparisons to Persons With an Eating Disorder and No Diabetes
The purpose of this study is to analyze a chart audit of patients seen at Park Nicollet Eating Disorder Institute (EDI) to identify and compare general characteristics of eating disorders with type 1 diabetes patients to a matched eating disordered population without type 1 diabetes, also seen at EDI.
Read the detailed description
The goal of this study is to conduct a chart audit on all patients with type 1 diabetes who have been seen collaboratively by International Diabetes Center (IDC) and Park Nicollet Eating Disorder Institute (EDI) staff from 2005 - 2008 and their matched eating disordered controls.
Research Questions
- What are the general characteristics of the ED DM T1 population?
- How are ED DM T1 patients different from the matched eating disordered patients with respect to race, marital status, age of onset, eating behaviors, self-reported highest and lowest weight, exercise frequency and duration, number of hospital admissions, number of emergency room visits, medication needs, and other medical and psychological/psychiatric comorbidities?
- How are ED DM T1 patients different from the matched eating disordered patients with respect to the affective and cognitive aspects of eating disorders such as self-reported depression symptoms, body image distortion, thoughts and feelings about eating, psychological concerns, readiness to change, self-esteem and anxiety?
- For ED DM T1 patients, what is the time relationship of the diagnosis of diabetes and an eating disorder?
- For ED DM T1 patients, what is the relationship of BMI and A1c?
- Conditions
- Eating Disorder, Type 1 Diabetes
- Keywords
- dual diagnosis
- Medical subject headings
- Feeding and Eating Disorders, Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Eating Disorder Diabetes Mellitus T1 patients | |
| 2 | Eating Disorder only patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
define general characteristics of the diabetes and eating disorder population
Measured: 2005 - 2008
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2009 (estimated)
- Study startMar 2010
- Primary completionSep 2010
- Study completionSep 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Eating DisorderStudies 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 154 participants (actual)
Sponsor and investigators
- Lead sponsor
- HealthPartners Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Park Nicollet Eating Disorder Institute, International Diabetes Center at Park Nicollet, Park Nicollet Foundation
- Responsible party
- Sponsor
- Investigators
- Margaret Powers, PhD, Principal investigator, International Diabetes Center at Park Nicollet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00945711
- Sponsor's protocol ID
- 03802-08-C
- Status last verified
- Aug 2013
- First submitted
- 22 Jul 2009
- Last updated
- 2 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characteristics of Persons With an Eating Disorder and Type 1 Diabetes and Psychological Comparisons to Persons With an Eating Disorder and No Diabetes
- ClinicalTrials.gov ID
- NCT00945711
- Acronym / sponsor ID
- 03802-08-C
- Conditions
- Eating Disorder, Type 1 Diabetes
- Keywords
- dual diagnosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 154 participants (actual)
- Lead sponsor
- HealthPartners InstituteUniversity, hospital or other
- Collaborators
- Park Nicollet Eating Disorder Institute, International Diabetes Center at Park Nicollet, Park Nicollet Foundation
- Study start
- Mar 2010
- Primary completion
- Sep 2010 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 24 Jul 2009 (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 analyze a chart audit of patients seen at Park Nicollet Eating Disorder Institute (EDI) to identify and compare general characteristics of eating disorders with type 1 diabetes patients to a matched eating disordered population without type 1 diabetes, also seen at EDI.
Detailed description
The goal of this study is to conduct a chart audit on all patients with type 1 diabetes who have been seen collaboratively by International Diabetes Center (IDC) and Park Nicollet Eating Disorder Institute (EDI) staff from 2005 - 2008 and their matched eating disordered controls.
Research Questions
- What are the general characteristics of the ED DM T1 population?
- How are ED DM T1 patients different from the matched eating disordered patients with respect to race, marital status, age of onset, eating behaviors, self-reported highest and lowest weight, exercise frequency and duration, number of hospital admissions, number of emergency room visits, medication needs, and other medical and psychological/psychiatric comorbidities?
- How are ED DM T1 patients different from the matched eating disordered patients with respect to the affective and cognitive aspects of eating disorders such as self-reported depression symptoms, body image distortion, thoughts and feelings about eating, psychological concerns, readiness to change, self-esteem and anxiety?
- For ED DM T1 patients, what is the time relationship of the diagnosis of diabetes and an eating disorder?
- For ED DM T1 patients, what is the relationship of BMI and A1c?
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Eating Disorder Diabetes Mellitus T1 patients |
| 2 | – | –Eating Disorder only patients |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Park Nicollet Eating Disorder Institute patient and International Diabetes Center type 1 diabetes patients
Key inclusion criteria (2 listed)
- patient seen in both Park Nicollet Eating Disorder Institute and International Diabetes Center for type 1 diabetes from 2005 - 2008
- patient seen only in Park Nicollet Eating Disorder Institute from 2005 - 2008
Key exclusion criteria (1 listed)
- none
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
define general characteristics of the diabetes and eating disorder population
Time frame: 2005 - 2008
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 2 Dec 2015.
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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.
Margaret Powers, PhD principal investigator
International Diabetes Center at Park Nicollet
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 Eating Disorder and Type 1 Diabetes, run by HealthPartners Institute 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 1 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 2 Dec 2015. 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.
What does the primary outcome measure?
define general characteristics of the diabetes and eating disorder population (time frame: 2005 - 2008). It is what the study was designed to measure, not a finding.
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 2 Dec 2015.