Observational
OtherThe same self-reported questionnaires and cognitive tests will be completed by both groups. There is no intervention.
NCT Number: NCT05487534
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.
Interested in participating?
Request Info18 year–65 year
All sexes
Observational
IRCM, Montreal, Canada
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:
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The same self-reported questionnaires and cognitive tests will be completed by both groups. There is no intervention.
Time frame: Day 1 (+/- 2 days)
To assess eating behaviors according to their glycemic variability.
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%).
Time frame: Inclusion
To assess self-management's skills.
Time frame: Inclusion
To assess self-management's skills.
Time frame: Inclusion
To assess anxiety disorders.
Time frame: Inclusion
To assess depression disorder.
Time frame: Inclusion
To assess diabetes literacy and numeracy skills.
Time frame: Inclusion (medical data)
Including eating disorders.
Time frame: Inclusion (medical data)
Number of years since the diagnosis of diabetes.
Time frame: Inclusion (medical data)
Pumps or injections of insulin.
Time frame: Inclusion (medical data)
The dose of insulin taken per day.
Time frame: Inclusion (medical data)
Number of years or months of its use, either self-monitoring with capillary glucose tests or CGMS.
Time frame: Inclusion (medical data)
Number of severe hypoglycemic episodes over the last year.
Time frame: Inclusion (medical data)
Past year and current medications (included use of psychotropic drugs to be considered as a potential confounding factor).
Time frame: Inclusion (medical data)
Number and type of diabetes complications.
Time frame: Inclusion (medical data)
Measured coefficient of variation based on previous CGMS and last available HbA1c (max 6 months).
Time frame: Inclusion (medical data)
Weight and height will be combined to report BMI in kg/m^2.
Time frame: Inclusion (medical data)
Waist, hips and neck circumferences will be self measured in cm with a measuring tape.
Time frame: Inclusion (biological data)
Measurement of cholesterol, HDL-cholesterol, LDL-cholesterol and triglycerides in mg/dL.
Time frame: Inclusion (biological data)
Measurement of fasting blood glucose in mg/dL.
Time frame: Inclusion (biological data)
Measurement of c-peptide in nmol/L.
Time frame: Inclusion (biological data)
otal cholesterol, triglycerides, HDL-cholesterol, LDL-cholesterol, fasting blood glucose, c-peptide, ghrelin fasting and CRP
Time frame: Inclusion (biological data)
Measurement of ghrelin fasting and CRP in mg/L.
Time frame: Day 1 (+/- 2 days)
To assess cognitive flexibility.
Time frame: Day 1 (+/- 2 days)
To screen for Attention Deficit Hyperactive Disorder (ADHD).
Time frame: Day 1 (+/- 2 days)
To assess attention.
Time frame: Day 4 (+/- 2 days)
To assess the level of interoception.
Time frame: Day 4 (+/- 2 days)
To assess eating behaviors.
Time frame: Day 4 (+/- 2 days)
To assess executive functioning.
Time frame: Day 4 (+/- 2 days)
To assess impulsivity and inhibition.
Time frame: Day 4 (+/- 2 days)
To assess temporal discounting.
Time frame: Day 8 (+/- 2 days)
To assess behavior impulsivity.
Time frame: Day 8 (+/- 2 days)
To estimate susceptibility to food reward.
Time frame: Day 8 (+/- 2 days)
To assess inhibition leverages by emotion recognition and regulation.
Time frame: Day 8 (+/- 2 days)
To assess the effects of threat stimuli on capturing and holding attention.
Contact information is provided by the study sponsor or research team.
Melissa Pelletier, M. Sc
CONTACT
+1 (418) 656-8711 ext. 2136
Sylvain Iceta, MD, PhD
CONTACT
+1 (418) 656-8711 ext. 4565
Laval University
Other
Impact of Glycemic Variability on Cognitive Impairment, Disordered Eating Behavior, and Self-management Skills in Patients Living with Type 1 Diabetes
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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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