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Recruiting Observational

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

NCT05487534 · tracked via the Priya Life Science Canada tracker
Phase
Observational
Started
2023-04-26
Last updated
2024-10-09

Condition(s) studied

Type 1 Diabetes

Investigational drug(s) / intervention(s)

Observational

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

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
65 Years
Healthy volunteers
No
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

Primary outcome measure(s)

  • Eating Disorder examination (EDE-Q) — Day 1 (+/- 2 days)
    To assess eating behaviors according to their glycemic variability.
  • Glucose variability and insulin resistance (CGMS - 10 days) — 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%).

Trial sites (2)

FacilityCityRegionStatus
IRCM Montreal Canada Recruiting
CHU de Québec Québec Canada Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05487534 on ClinicalTrials.gov ↗ ← All trials in Canada