Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05346679
Other study ID # DEPS-R Adult
Secondary ID
Status Completed
Phase
First received
Last updated
Start date March 1, 2021
Est. completion date February 28, 2022

Study information

Verified date January 2024
Source Ege University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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.


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).


Recruitment information / eligibility

Status Completed
Enrollment 100
Est. completion date February 28, 2022
Est. primary completion date October 30, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years to 50 Years
Eligibility Inclusion Criteria: - Duration of T1D =1 year - A regular follow-up for at least 1 year (4 visits/year) - No major medical problems related to nutrition Exclusion Criteria: - Have major medical problems related to nutrition ( etc. celiac disorders, cystic fibrosis, dyslipidemia,.....)

Study Design


Locations

Country Name City State
Turkey Istanbul University Istanbul

Sponsors (2)

Lead Sponsor Collaborator
Ege University Istanbul University

Country where clinical trial is conducted

Turkey, 

References & Publications (6)

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. — View Citation

Karastogiannidou 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. — View Citation

Watt 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. — View Citation

Wisting 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. — View Citation

Wisting 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. — View Citation

Yilmaz 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 Feb 11;131:109960. doi: 10.1016/j.jpsychores.2020.109960. Online ahead of print. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Day 1
Primary 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. Day 1
Primary Duration of diabetes (years) It will be calculated by subtracting the diabetes onset date from the date the patient was included in the study. Day 1
Primary HbA1c number Day 1
Primary BMI number Day 1
See also
  Status Clinical Trial Phase
Recruiting NCT05653518 - Artificial Pancreas Technology to Reduce Glycemic Variability and Improve Cardiovascular Health in Type 1 Diabetes N/A
Enrolling by invitation NCT05515939 - Evaluating the InPen in Pediatric Type 1 Diabetes
Completed NCT05109520 - Evaluation of Glycemic Control and Quality of Life in Adults With Type 1 Diabetes During Continuous Glucose Monitoring When Switching to Insulin Glargine 300 U/mL
Recruiting NCT04016987 - Automated Structured Education Based on an App and AI in Chinese Patients With Type 1 Diabetes N/A
Active, not recruiting NCT04190368 - Team Clinic: Virtual Expansion of an Innovative Multi-Disciplinary Care Model for Adolescents and Young Adults With Type 1 Diabetes N/A
Recruiting NCT05413005 - Efficacy of Extracorporeal Photopheresis (ECP) in the Treatment of Type 1 Diabetes Mellitus Early Phase 1
Active, not recruiting NCT04668612 - Dual-wave Boluses in Children With Type 1 Diabetes Insulin Boluses in Children With Type 1 Diabetes N/A
Completed NCT02837094 - Enhanced Epidermal Antigen Specific Immunotherapy Trial -1 Phase 1
Recruiting NCT05414409 - The Gut Microbiome in Type 1 Diabetes and Mechanism of Metformin Action Phase 2
Recruiting NCT05670366 - The Integration of Physical Activity Into the Clinical Decision Process of People With Type 1 Diabetes N/A
Active, not recruiting NCT05418699 - Real-life Data From Diabetic Patients on Closed-loop Pumps
Completed NCT04084171 - Safety of Artificial Pancreas Therapy in Preschoolers, Age 2-6 N/A
Recruiting NCT06144554 - Post Market Registry for the Omnipod 5 System in Children and Adults With Type 1 Diabetes
Recruiting NCT05153070 - Ciclosporin Followed by Low-dose IL-2 in Patients With Recently Diagnosed Type 1 Diabetes Phase 2
Recruiting NCT05379686 - Low-Dose Glucagon and Advanced Hybrid Closed-Loop System for Prevention of Exercise-Induced Hypoglycaemia in People With Type 1 Diabetes N/A
Completed NCT05281614 - Immune Effects of Vedolizumab With or Without Anti-TNF Pre-treatment in T1D Early Phase 1
Withdrawn NCT04259775 - Guided User-initiated Insulin Dose Enhancements (GUIDE) to Improve Outcomes for Youth With Type 1 Diabetes N/A
Active, not recruiting NCT01600924 - Study on the Assessment of Determinants of Muscle and Bone Strength Abnormalities in Diabetes
Completed NCT02855307 - Closed-loop Control of Glucose Levels (Artificial Pancreas) During Postprandial Exercise in Adults With Type 1 Diabetes Phase 2
Completed NCT02914886 - Beneficial Effect of Insulin Glulisine by Lipoatrophy and Type 1 Diabetes (LAS) Phase 4