Do "Sugar Swings" Impact the Brain Function and the Eating Behaviors of People With Type 1 Diabetes

Type 1 Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05487534
• Other study ID #: MP-20-2023-6466
• Status: Recruiting
• Start date: April 26, 2023
• Est. completion date: September 2026

Study information

• Verified date: May 2023
• Source: Laval University
• Contact: Sylvain Iceta, MD, PhD
• Phone: +1 (418) 656-8711
• Email: equipe.iceta[@]criucpq.ulaval.ca
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: September 2026
• Est. primary completion date: September 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Type 1 Diabetes

Intervention

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

Locations

Country	Name	City	State
Canada	IRCM	Montréal
Canada	CHU de Québec	Québec

Sponsors (5)

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

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Eating Disorder examination (EDE-Q)	To assess eating behaviors according to their glycemic variability.	Day 1 (+/- 2 days)
Primary	Glucose variability and insulin resistance (CGMS - 10 days)	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%).	Start at inclusion (Day 1 to Day 10)
Secondary	Distress Diabetes Scale (T1-DDS)	To assess self-management's skills.	Inclusion
Secondary	Diabetes Behavior Ratting Scale (DBRS)	To assess self-management's skills.	Inclusion
Secondary	Generalized Anxiety Disorder (GAD-7)	To assess anxiety disorders.	Inclusion
Secondary	Patient Health Questionnaire (PHQ-9)	To assess depression disorder.	Inclusion
Secondary	Diabetes Numeracy Test (DNT-15)	To assess diabetes literacy and numeracy skills.	Inclusion
Secondary	Physical and psychological comorbidities	Including eating disorders.	Inclusion (medical data)
Secondary	Diabetes Information : Duration	Number of years since the diagnosis of diabetes.	Inclusion (medical data)
Secondary	Diabetes Information : Modality of insulin delivery	Pumps or injections of insulin.	Inclusion (medical data)
Secondary	Diabetes Information : Total daily insulin dose	The dose of insulin taken per day.	Inclusion (medical data)
Secondary	Diabetes Information : Duration of diabetes self-monitoring	Number of years or months of its use, either self-monitoring with capillary glucose tests or CGMS.	Inclusion (medical data)
Secondary	Diabetes Information : Severe hypoglycemic episodes	Number of severe hypoglycemic episodes over the last year.	Inclusion (medical data)
Secondary	Diabetes Information : Medication	Past year and current medications (included use of psychotropic drugs to be considered as a potential confounding factor).	Inclusion (medical data)
Secondary	Diabetes Information : Diabetes complications	Number and type of diabetes complications.	Inclusion (medical data)
Secondary	Diabetes Information : Coefficient of variation	Measured coefficient of variation based on previous CGMS and last available HbA1c (max 6 months).	Inclusion (medical data)
Secondary	Anthropometric markers : BMI	Weight and height will be combined to report BMI in kg/m^2.	Inclusion (medical data)
Secondary	Anthropometric markers : Waist, hips and neck circumferences	Waist, hips and neck circumferences will be self measured in cm with a measuring tape.	Inclusion (medical data)
Secondary	Biological information : Cholesterol and triglycerides	Measurement of cholesterol, HDL-cholesterol, LDL-cholesterol and triglycerides in mg/dL.	Inclusion (biological data)
Secondary	Biological information : Fasting blood glucose	Measurement of fasting blood glucose in mg/dL.	Inclusion (biological data)
Secondary	Biological information : C-peptide	Measurement of c-peptide in nmol/L.	Inclusion (biological data)
Secondary	Biological information : Triglycerides	otal cholesterol, triglycerides, HDL-cholesterol, LDL-cholesterol, fasting blood glucose, c-peptide, ghrelin fasting and CRP	Inclusion (biological data)
Secondary	Biological information : Ghrelin fasting and C-Reactive protein (CRP)	Measurement of ghrelin fasting and CRP in mg/L.	Inclusion (biological data)
Secondary	Detail and Flexibility Questionnaire (DFQ)	To assess cognitive flexibility.	Day 1 (+/- 2 days)
Secondary	Adult ADHD Self-Report Scale (ASRS)	To screen for Attention Deficit Hyperactive Disorder (ADHD).	Day 1 (+/- 2 days)
Secondary	Category Switch Task	To assess attention.	Day 1 (+/- 2 days)
Secondary	Multidimensional Assessment of Interoceptive Awareness Version 2 (MAIA)	To assess the level of interoception.	Day 4 (+/- 2 days)
Secondary	Binge Eating Scale (BES)	To assess eating behaviors.	Day 4 (+/- 2 days)
Secondary	Tower of London Task	To assess executive functioning.	Day 4 (+/- 2 days)
Secondary	Stop Signal Task	To assess impulsivity and inhibition.	Day 4 (+/- 2 days)
Secondary	5-Trial Adjusting Delay Discounting	To assess temporal discounting.	Day 4 (+/- 2 days)
Secondary	Short UPPS-P Impulsive Behavior Scale	To assess behavior impulsivity.	Day 8 (+/- 2 days)
Secondary	Modified Yale Food Addiction Scale 2.0 (mYFAS 2.0)	To estimate susceptibility to food reward.	Day 8 (+/- 2 days)
Secondary	Emotional Go/No-Go Task	To assess inhibition leverages by emotion recognition and regulation.	Day 8 (+/- 2 days)
Secondary	Attentional Cueing Procedure	To assess the effects of threat stimuli on capturing and holding attention.	Day 8 (+/- 2 days)