Skip to main content
OpenTrials
Recruiting

NCT Number: NCT05487534

Do "sugar Swings" Impact the Brain Function and the Eating Behaviors of People with Type 1 Diabetes

In type 1 diabetes, it is common to choose the food we eat according to the blood sugar level and the insulin dose and vice versa. Beyond the nutritional aspects, the relationship to food and the resulting eating behaviors can be a source of suffering. Also, it has been reported that one out of two people over 60 years of age living with type 1 diabetes has cognitive impairment. Changes in cognitive functions can have important implications for daily well-being, diet (e.g., the ability to modulate cravings), and treatment decisions to manage diabetes.

One factor that can affect both eating behaviors and cognitive function is variation in blood glucose levels.

This research aims to better understand the impact of glycemic variability in disordered eating behaviors and cognitive impairment, and its consequences on self-management skills in people with type 1 diabetes.

The hypotheses are that i) higher glycemic variability is associated with higher disordered eating behaviors and poorer cognitive function in people with type 1 diabetes, and that differences exist between sexes, ii) higher disordered eating behaviors and poorer cognitive function are associated with lower self-management skills; and iii) cognitive impairment, interoception awareness and insulin resistance may mediate the relationship between glycemic variability and disordered eating behaviors.

This research study will contribute to highlighting the consequences of blood sugar fluctuations, "sugar swings", in daily life, in particular the way they disrupt eating behaviors and brain function. A better understanding of the mechanisms involved could eventually allow for early detection and management of these problems. Our study will also seek to understand the patients' point of view, which will allow the design of appropriate and meaningful recommendations.

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

IRCM, Montreal, Canada

Loading trial locations.

About this study

All assessments will be done in virtual mode through secure platforms (but also offered in person in Quebec City if needed to limit discrimination).

The study will start with an inclusion visit during which self-reported and medical data will be collected as well as some anthropometric parameters measured. Following the visit, the participant will be asked to wear a continuous glucose sensor provided by the investigator (Dexcom®) to perform a continuous glucose recording for 10 days. During this 10-day period, the participant will be required to complete:

  • A food diary during 3 weekdays and 1 weekend day using the Keenoa® app.
  • 3 online sessions combining questionnaires (using the Redcap platform) and computerized tests (Inquisit® platform). Each session will last approximately 45 minutes (can vary between 30 and 60 minutes).

Participants who wish to participate in the qualitative phase of this study will also be offered the opportunity to do so. Participants will be recruited consecutively until a total of 50 are reached. For this part of the study, an individual interview will be conducted by a professional specifically trained in this method of analysis. This meeting will last on average 1.5 hours, but may last up to 2.5 hours depending on the length of the discussion. There will be an audio and video recording of this meeting. The discussions will then be transcribed into text and analyzed.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Type 1 diabetes (> 12 months)
  • Age between 18 and 65 years old
  • 6.5 % < A1C < 9% (to avoid potential severe eating disorder)

Exclusion criteria

  • Type 2 diabetes or other form of diabetes; gastroparesis (clinical diagnosis);
  • Recent (< 6 months) major cardiovascular event (e.g. myocardial infarction, cerebrovascular accident, major revascularization)
  • Recent (< 12 weeks) severe hypoglycemia episodes (<2.8 mmol/L or assistance from a third party)
  • Recent (< 12 weeks) changes in insulin type or delivery method
  • Automated Insulin Delivery
  • History of severe brain trauma, epilepsy, schizophrenia or bipolar disorders
  • Inability to use a computer
  • Incorrect vision or auditory problems

Treatment and study plan

Observational

Other

The same self-reported questionnaires and cognitive tests will be completed by both groups. There is no intervention.

Primary outcomes

  1. Eating Disorder examination (EDE-Q)

    Time frame: Day 1 (+/- 2 days)

    To assess eating behaviors according to their glycemic variability.

  2. Glucose variability and insulin resistance (CGMS - 10 days)

    Time frame: Start at inclusion (Day 1 to Day 10)

    CGMS will be performed over a 10-day period using a DEXCOM G6 to separate participants into groups based on glycemic variation (i.e., a coefficient of variation [CV] >36% over a 10-day CGMS) versus those with a low glucose variability (i.e., CV <36%).

Secondary outcomes

  1. Distress Diabetes Scale (T1-DDS)

    Time frame: Inclusion

    To assess self-management's skills.

  2. Diabetes Behavior Ratting Scale (DBRS)

    Time frame: Inclusion

    To assess self-management's skills.

  3. Generalized Anxiety Disorder (GAD-7)

    Time frame: Inclusion

    To assess anxiety disorders.

  4. Patient Health Questionnaire (PHQ-9)

    Time frame: Inclusion

    To assess depression disorder.

  5. Diabetes Numeracy Test (DNT-15)

    Time frame: Inclusion

    To assess diabetes literacy and numeracy skills.

  6. Physical and psychological comorbidities

    Time frame: Inclusion (medical data)

    Including eating disorders.

  7. Diabetes Information : Duration

    Time frame: Inclusion (medical data)

    Number of years since the diagnosis of diabetes.

  8. Diabetes Information : Modality of insulin delivery

    Time frame: Inclusion (medical data)

    Pumps or injections of insulin.

  9. Diabetes Information : Total daily insulin dose

    Time frame: Inclusion (medical data)

    The dose of insulin taken per day.

  10. Diabetes Information : Duration of diabetes self-monitoring

    Time frame: Inclusion (medical data)

    Number of years or months of its use, either self-monitoring with capillary glucose tests or CGMS.

  11. Diabetes Information : Severe hypoglycemic episodes

    Time frame: Inclusion (medical data)

    Number of severe hypoglycemic episodes over the last year.

  12. Diabetes Information : Medication

    Time frame: Inclusion (medical data)

    Past year and current medications (included use of psychotropic drugs to be considered as a potential confounding factor).

  13. Diabetes Information : Diabetes complications

    Time frame: Inclusion (medical data)

    Number and type of diabetes complications.

  14. Diabetes Information : Coefficient of variation

    Time frame: Inclusion (medical data)

    Measured coefficient of variation based on previous CGMS and last available HbA1c (max 6 months).

  15. Anthropometric markers : BMI

    Time frame: Inclusion (medical data)

    Weight and height will be combined to report BMI in kg/m^2.

  16. Anthropometric markers : Waist, hips and neck circumferences

    Time frame: Inclusion (medical data)

    Waist, hips and neck circumferences will be self measured in cm with a measuring tape.

  17. Biological information : Cholesterol and triglycerides

    Time frame: Inclusion (biological data)

    Measurement of cholesterol, HDL-cholesterol, LDL-cholesterol and triglycerides in mg/dL.

  18. Biological information : Fasting blood glucose

    Time frame: Inclusion (biological data)

    Measurement of fasting blood glucose in mg/dL.

  19. Biological information : C-peptide

    Time frame: Inclusion (biological data)

    Measurement of c-peptide in nmol/L.

  20. Biological information : Triglycerides

    Time frame: Inclusion (biological data)

    otal cholesterol, triglycerides, HDL-cholesterol, LDL-cholesterol, fasting blood glucose, c-peptide, ghrelin fasting and CRP

  21. Biological information : Ghrelin fasting and C-Reactive protein (CRP)

    Time frame: Inclusion (biological data)

    Measurement of ghrelin fasting and CRP in mg/L.

  22. Detail and Flexibility Questionnaire (DFQ)

    Time frame: Day 1 (+/- 2 days)

    To assess cognitive flexibility.

  23. Adult ADHD Self-Report Scale (ASRS)

    Time frame: Day 1 (+/- 2 days)

    To screen for Attention Deficit Hyperactive Disorder (ADHD).

  24. Category Switch Task

    Time frame: Day 1 (+/- 2 days)

    To assess attention.

  25. Multidimensional Assessment of Interoceptive Awareness Version 2 (MAIA)

    Time frame: Day 4 (+/- 2 days)

    To assess the level of interoception.

  26. Binge Eating Scale (BES)

    Time frame: Day 4 (+/- 2 days)

    To assess eating behaviors.

  27. Tower of London Task

    Time frame: Day 4 (+/- 2 days)

    To assess executive functioning.

  28. Stop Signal Task

    Time frame: Day 4 (+/- 2 days)

    To assess impulsivity and inhibition.

  29. 5-Trial Adjusting Delay Discounting

    Time frame: Day 4 (+/- 2 days)

    To assess temporal discounting.

  30. Short UPPS-P Impulsive Behavior Scale

    Time frame: Day 8 (+/- 2 days)

    To assess behavior impulsivity.

  31. Modified Yale Food Addiction Scale 2.0 (mYFAS 2.0)

    Time frame: Day 8 (+/- 2 days)

    To estimate susceptibility to food reward.

  32. Emotional Go/No-Go Task

    Time frame: Day 8 (+/- 2 days)

    To assess inhibition leverages by emotion recognition and regulation.

  33. Attentional Cueing Procedure

    Time frame: Day 8 (+/- 2 days)

    To assess the effects of threat stimuli on capturing and holding attention.

Study contacts

Contact information is provided by the study sponsor or research team.

Melissa Pelletier, M. Sc

CONTACT

[email protected]

+1 (418) 656-8711 ext. 2136

Sylvain Iceta, MD, PhD

CONTACT

[email protected]

+1 (418) 656-8711 ext. 4565

Sponsors and collaborators

Lead sponsor

Laval University

Other

Collaborators

  • CHU de Quebec-Universite Laval
  • Centre d'expertise Poids, Image et Alimentation (CEPIA)
  • Institut de Recherches Cliniques de Montreal
  • Institut universitaire de cardiologie et de pneumologie de Québec, University Laval

Registry information

Official study title

Impact of Glycemic Variability on Cognitive Impairment, Disordered Eating Behavior, and Self-management Skills in Patients Living with Type 1 Diabetes

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Aug 4, 2022
Registry last updated
Oct 9, 2024

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.

Published trials that share one or more normalized conditions with this study.