Type 1 DiabetesDEPS-RNCT05346679
DEPS-R Turkish Version in Adults With Type 1Diabetes
An observational study of Type 1 Diabetes, run by Ege University at 1 site in Turkey (Türkiye).
Trial summary
A growing body of research has revealed the good psychometric properties and three-component factor structure of DEPS-R in children and adolescents with type 1 diabetes (T1D) but research with adults has limited and has differing results. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Type 1 Diabetes
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2021to 28 Feb 2022
- 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 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Study population: The sample of this study consists of 100 participants with T1D who were being followed at the Istanbul University, Istanbul Faculty of Medicine, Endocrine and Diabetes Outpatient Clinic.
Who may be able to join
- Duration of T1D ≥1 year
- A regular follow-up for at least 1 year (4 visits/year)
- No major medical problems related to nutrition
Who cannot join
- Have major medical problems related to nutrition ( etc. celiac disorders, cystic fibrosis, dyslipidemia,.....)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: DIABETES EATING PROBLEM SURVEY- REVISED (DEPS-R) AMONG ADULTS WITH TYPE 1 DIABETES
A growing body of research has revealed the good psychometric properties and three-component factor structure of DEPS-R in children and adolescents with type 1 diabetes (T1D) but research with adults has limited and has differing results. The Diabetes Eating Problem Survey-Revised (DEPS-R) developed by Markowitz et al is a diabetes-specific self-report instrument to screen eating disorders for individuals with T1D. DEPS-R is a 16-item diabetes-specific self-report questionnaire to test for diabetes-specific eating disorders. Answers are scored on a six-point Likert scale, with higher scores indicating more DEB and a total score of ≥20 indicating a high risk for eating disorders (range 0-80). The original DEPS-R has been shown to have a good internal consistency (Cronbach's alpha=0.86) and construct validity in a sample of the pediatric population with T1D. This study aimed to evaluate the validity and reliability of the Turkish version of the DEPS-R questionnaire for adults with T1D, investigate its psychometric properties and factor structure, and examine its relationship with the EDE-Q questionnaire.
Read the detailed description
In this cross-sectional study, participants answered a DEPS-R and EDE-Q questionnaire during a regularly scheduled medical visit after obtaining written informed consent. All participants had established that patients with T1D were treated with multiple daily insulin or insulin pump therapy. Height was measured using a stadiometer to the nearest 0.1 cm in all participants. Weight was measured unclothed to the nearest 0.1 kg using a calibrated balance scale. Body Mass Index (BMI) was calculated by using the weight (kg)/height (m²) equation. Clinical data including HbA1c, T1D onset, birth date, and treatment model etc. was conducted as part of a standard clinical assessment. HbA1c was measured with ion-exchange high-performance liquid chromatography (Bio-rad Variant ll Turbo, Japan).
- Conditions
- Type 1 Diabetes
- Keywords
- type 1 diabetes, DEPS-R, confirmatory factor analysis, diabulimia, distributed eating disorder
- Medical subject headings
- Diabetes Mellitus, Type 1, Diabulimia
What is being measured
The primary outcome is the main question the study is designed to answer.
DEPS-R Score
Diabetes Eating Problem Survey-Revised, min score 0, max score 80 DEPS-R score DEP-R score ≥20 indicating a high risk for eating disorders
Measured: Day 1
EDE-Q Score
Eating Disorders Examination Questionnaire It consists of four subscales eating restraint, eating concern, shape concern, and weight concern. The global score represents an average of the four subscale scores, with higher scores indicating greater eating pathology.
Measured: Day 1
Duration of diabetes (years)
It will be calculated by subtracting the diabetes onset date from the date the patient was included in the study.
Measured: Day 1
HbA1c
number
Measured: Day 1
BMI
number
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2022
- Study start1 Mar 2021
- Primary completion30 Oct 2021
- Study completion28 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Type 1 DiabetesStudies of the same condition, open and under way.
- More trials run by Ege UniversityThe sponsor's other registered studies.
- 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 only
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ege University
- Sponsor type
- University, hospital or other
- Collaborators
- Istanbul University
- Responsible party
- Principal investigator, Yasemin Atik Altinok, Ege University
- Investigators
- yasemin A atik-altınok, PhD, Study chair, ege university department of pediatrics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05346679
- Sponsor's protocol ID
- DEPS-R Adult
- Acronym
- DEPS-R
- Status last verified
- Jan 2024
- First submitted
- 16 Apr 2022
- Last updated
- 18 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Atik Altinok Y, Ozgur S, Meseri R, Ozen S, Darcan S, Goksen D. Reliability and Validity of the Diabetes Eating Problem Survey in Turkish Children and Adolescents with Type 1 Diabetes Mellitus. J Clin Res Pediatr Endocrinol. 2017 Dec 15;9(4):323-328. doi: 10.4274/jcrpe.4219. Epub 2017 Feb 23.
PubMed 28270369Karastogiannidou C, Giannoulaki P, Samaras I, Kotzakioulafi E, Didangelos T, Bocsan IC, Vassilopoulou E. The Diabetes Eating Problem Survey-Revised (DEPS-R) in a Greek Adult Population with Type 1 Diabetes Mellitus: Model Comparison Supporting a Single Factor Structure. Nutrients. 2021 Jul 12;13(7):2375. doi: 10.3390/nu13072375.
PubMed 34371885Wisting L, Wonderlich J, Skrivarhaug T, Dahl-Jorgensen K, Ro O. Psychometric properties and factor structure of the diabetes eating problem survey - revised (DEPS-R) among adult males and females with type 1 diabetes. J Eat Disord. 2019 Jan 17;7:2. doi: 10.1186/s40337-018-0232-0. eCollection 2019.
PubMed 30675355Wisting L, Froisland DH, Skrivarhaug T, Dahl-Jorgensen K, Ro O. Psychometric properties, norms, and factor structure of the diabetes eating problem survey-revised in a large sample of children and adolescents with type 1 diabetes. Diabetes Care. 2013 Aug;36(8):2198-202. doi: 10.2337/dc12-2282. Epub 2013 Mar 27.
PubMed 23536586Yilmaz Kafali H, Atik Altinok Y, Ozbaran B, Ozen S, Kose S, Tahillioglu A, Darcan S, Goksen D. Exploring emotional dysregulation characteristics and comorbid psychiatric disorders in type 1 diabetic children with disordered eating behavior risk. J Psychosom Res. 2020 Apr;131:109960. doi: 10.1016/j.jpsychores.2020.109960. Epub 2020 Feb 11.
PubMed 32070835Watt A, Ng AH, Sandison A, Fourlanos S, Bramley A. Prevalence of disordered eating in adults with type 1 diabetes in an Australian metropolitan hospital. Health Soc Care Community. 2022 Jul;30(4):e974-e980. doi: 10.1111/hsc.13500. Epub 2021 Jul 12.
PubMed 34250682Atik-Altinok Y, Eliuz-Tipici B, Idiz C, Ozgur S, Ok AM, Karsidag K. Psychometric properties and factor structure of the diabetes eating problem survey- revised (DEPS-R) among adults with type 1 diabetes mellitus. Eat Weight Disord. 2023 Sep 4;28(1):71. doi: 10.1007/s40519-023-01602-y.
PubMed 37665472
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DIABETES EATING PROBLEM SURVEY- REVISED (DEPS-R) AMONG ADULTS WITH TYPE 1 DIABETES
- ClinicalTrials.gov ID
- NCT05346679
- Acronym / sponsor ID
- DEPS-R / DEPS-R Adult
- Conditions
- Type 1 Diabetes
- Keywords
- type 1 diabetes, DEPS-R, confirmatory factor analysis, diabulimia, distributed eating disorder
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Ege UniversityUniversity, hospital or other
- Collaborators
- Istanbul University
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 30 Oct 2021 (actual)
- Study completion
- 28 Feb 2022 (actual)
- First posted
- 26 Apr 2022 (actual)
- 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.
A growing body of research has revealed the good psychometric properties and three-component factor structure of DEPS-R in children and adolescents with type 1 diabetes (T1D) but research with adults has limited and has differing results. The Diabetes Eating Problem Survey-Revised (DEPS-R) developed by Markowitz et al is a diabetes-specific self-report instrument to screen eating disorders for individuals with T1D. DEPS-R is a 16-item diabetes-specific self-report questionnaire to test for diabetes-specific eating disorders. Answers are scored on a six-point Likert scale, with higher scores indicating more DEB and a total score of ≥20 indicating a high risk for eating disorders (range 0-80). The original DEPS-R has been shown to have a good internal consistency (Cronbach's alpha=0.86) and construct validity in a sample of the pediatric population with T1D. This study aimed to evaluate the validity and reliability of the Turkish version of the DEPS-R questionnaire for adults with T1D, investigate its psychometric properties and factor structure, and examine its relationship with the EDE-Q questionnaire.
Detailed description
In this cross-sectional study, participants answered a DEPS-R and EDE-Q questionnaire during a regularly scheduled medical visit after obtaining written informed consent. All participants had established that patients with T1D were treated with multiple daily insulin or insulin pump therapy. Height was measured using a stadiometer to the nearest 0.1 cm in all participants. Weight was measured unclothed to the nearest 0.1 kg using a calibrated balance scale. Body Mass Index (BMI) was calculated by using the weight (kg)/height (m²) equation. Clinical data including HbA1c, T1D onset, birth date, and treatment model etc. was conducted as part of a standard clinical assessment. HbA1c was measured with ion-exchange high-performance liquid chromatography (Bio-rad Variant ll Turbo, Japan).
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- The sample of this study consists of 100 participants with T1D who were being followed at the Istanbul University, Istanbul Faculty of Medicine, Endocrine and Diabetes Outpatient Clinic.
Key inclusion criteria (3 listed)
- Duration of T1D ≥1 year
- A regular follow-up for at least 1 year (4 visits/year)
- No major medical problems related to nutrition
Key exclusion criteria (1 listed)
- Have major medical problems related to nutrition ( etc. celiac disorders, cystic fibrosis, dyslipidemia,.....)
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
DEPS-R Score
Time frame: Day 1
Diabetes Eating Problem Survey-Revised, min score 0, max score 80 DEPS-R score DEP-R score ≥20 indicating a high risk for eating disorders
EDE-Q Score
Time frame: Day 1
Eating Disorders Examination Questionnaire It consists of four subscales eating restraint, eating concern, shape concern, and weight concern. The global score represents an average of the four subscale scores, with higher scores indicating greater eating pathology.
Duration of diabetes (years)
Time frame: Day 1
It will be calculated by subtracting the diabetes onset date from the date the patient was included in the study.
HbA1c
Time frame: Day 1
number
BMI
Time frame: Day 1
number
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 18 Jan 2024.
- Background: PubMed 28270369Atik Altinok Y, Ozgur S, Meseri R, Ozen S, Darcan S, Goksen D. Reliability and Validity of the Diabetes Eating Problem Survey in Turkish Children and Adolescents with Type 1 Diabetes Mellitus. J Clin Res Pediatr Endocrinol. 2017 Dec 15;9(4):323-328. doi: 10.4274/jcrpe.4219. Epub 2017 Feb 23.
- Background: PubMed 34371885Karastogiannidou C, Giannoulaki P, Samaras I, Kotzakioulafi E, Didangelos T, Bocsan IC, Vassilopoulou E. The Diabetes Eating Problem Survey-Revised (DEPS-R) in a Greek Adult Population with Type 1 Diabetes Mellitus: Model Comparison Supporting a Single Factor Structure. Nutrients. 2021 Jul 12;13(7):2375. doi: 10.3390/nu13072375.
- Background: PubMed 30675355Wisting L, Wonderlich J, Skrivarhaug T, Dahl-Jorgensen K, Ro O. Psychometric properties and factor structure of the diabetes eating problem survey - revised (DEPS-R) among adult males and females with type 1 diabetes. J Eat Disord. 2019 Jan 17;7:2. doi: 10.1186/s40337-018-0232-0. eCollection 2019.
- Background: PubMed 23536586Wisting L, Froisland DH, Skrivarhaug T, Dahl-Jorgensen K, Ro O. Psychometric properties, norms, and factor structure of the diabetes eating problem survey-revised in a large sample of children and adolescents with type 1 diabetes. Diabetes Care. 2013 Aug;36(8):2198-202. doi: 10.2337/dc12-2282. Epub 2013 Mar 27.
- Background: PubMed 32070835Yilmaz Kafali H, Atik Altinok Y, Ozbaran B, Ozen S, Kose S, Tahillioglu A, Darcan S, Goksen D. Exploring emotional dysregulation characteristics and comorbid psychiatric disorders in type 1 diabetic children with disordered eating behavior risk. J Psychosom Res. 2020 Apr;131:109960. doi: 10.1016/j.jpsychores.2020.109960. Epub 2020 Feb 11.
- Background: PubMed 34250682Watt A, Ng AH, Sandison A, Fourlanos S, Bramley A. Prevalence of disordered eating in adults with type 1 diabetes in an Australian metropolitan hospital. Health Soc Care Community. 2022 Jul;30(4):e974-e980. doi: 10.1111/hsc.13500. Epub 2021 Jul 12.
- Derived from this study: PubMed 37665472Atik-Altinok Y, Eliuz-Tipici B, Idiz C, Ozgur S, Ok AM, Karsidag K. Psychometric properties and factor structure of the diabetes eating problem survey- revised (DEPS-R) among adults with type 1 diabetes mellitus. Eat Weight Disord. 2023 Sep 4;28(1):71. doi: 10.1007/s40519-023-01602-y.
- Individual participant dataSharing planned: Undecided
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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.
yasemin A atik-altınok, PhD study chair
ege university department of pediatrics
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 Type 1 Diabetes, run by Ege University at 1 site in Turkey (Türkiye).
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 3 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 18 Jan 2024. 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 Turkey (Türkiye). 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?
DEPS-R Score (time frame: Day 1). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05346679, which also lists 7 linked publications.
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 18 Jan 2024.