IUCPQ
Québec, Canada
NCT Number: NCT05476861
Type 1 Diabetes management is requiring and implies numerous lifestyle modifications. Insulin restriction to control weight is a frequent phenomenon, affecting up to 40% of PWT1D. Broadly, purging or binge eating behaviors are also frequently disordered eating behaviors (DEB) in people living with a Type 1 Diabetes (associated or not with restrictive eating behaviors). In a study on adolescents with T1D, the prevalence of moderate or high level of DEB ranged from 21% to 32%. Moreover, the presence of binge eating behavior seems to be associated with higher anxiety and depression levels.
Omitting insulin for weight control has been associated with the highest rates of retinopathy and nephropathy when compared to other weight control behaviors and to increase the risk of mortality by 3.2 times and decrease life spans from an average of 58 to 44 years at 11-year follow-up. Moreover, insulin misuse may be much more complex behavior than just the need for weight control. These behaviors may also involve increased distress, loss of control, and feelings of regret, guilt, and shame.
Interestingly, most studies of eating disorders and type 1 diabetes use question regarding insulin omission as a surrogate marker for eating disorders and disordered eating. For instance, the question used in the BETTER registry are: "In the past 12 months, did you intentionally omit insulin injections with the objective of losing weight?" or "In a typical week, how often do you miss an insulin dose?". However, the validity and robustness of such a marker have not been specifically investigated yet.
Our study objectives are : 1) To confirm that participants who reported intentionally omitting insulin had significantly more disordered eating behavior (based on the review of food records available); 2) To compare the prevalence and the severity of physical and mental health comorbidities (e.g., diabetes micro and macrovascular complications, glycated hemoglobin levels, current and past psychiatric disorders, distress related to diabetes) in people living with diabetes having or not declared to intentionally omit insulin; 3) To establish, using machine learning techniques, the main factors associated with intentional insulin omission behavior, taking into account biological, anthropometric and psychometric factors.
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Notify Me14 year and older
All sexes
Observational
Québec, Canada
Our main hypotheses:
Statistical Analysis:
The normality of the data distribution will be checked for each value using a graphical analysis of the distribution and a Kolmogorov-Smirnov test before parametric tests are performed. A description of the characteristics of the participants included in this study will be performed. Continuous variables will be presented by the mean and standard deviation for normal distributions, median and range for others. Categorical variables will be presented by the number and percentage of each modality. The level of significance of the tests must be equal or lower than 0.05. The risk of alpha error is set at 0.05, with Bonferroni correction if necessary.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: Baseline
"In the past 12 months, did you intentionally omit insulin injections with the objective of losing weight?" "In a typical week, how often do you miss an insulin dose?"
Time frame: Baseline
Time frame: Baseline
Time frame: Baseline
If any.
Time frame: Baseline
In units.
Time frame: Baseline
Like hypoglycemia, diabetic ketoacidosis (DKA), micro- and macro-vascular.
Time frame: Baseline
Including celiac disease.
Time frame: Baseline
The medication that is being taken for depression, if any.
Time frame: Baseline
The Patient Health Questionnaire (9 items).
Time frame: Baseline
Macronutrients per meal total per day.
Time frame: Baseline
Including portions and macronutrients.
Time frame: Baseline
If any.
Time frame: Baseline
Per day.
Time frame: Baseline
Weight and height will be combined to report BMI in kg/m^2.
Time frame: Baseline
In cm.
Laval University
Other
Is Insulin Omission a Surrogate Marker of Eating Disorders and Severity of Diabetes-related Distress: an Exploratory Study.
Acronym: iOS
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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